COVID-19 tracker: Moderna vaccine snares U.S. emergency nod; Europe to review Pfizer, BioNTech’s shot Monday

127 min readDec 21, 2020

The U.S. authorized its second COVID-19 vaccine Friday, clearing Moderna’s mRNA shot for emergency use in people ages 18 and older. Meanwhile, the European Medicines Agency’s Committee for Medicinal Products for Human Use endorsed Pfizer and BioNTech’s shot for a conditional nod in Europe Monday.

China, meanwhile, hopes to vaccinate 50 million people ahead of the Lunar New Year on Feb. 15, when hundreds of millions of people are expected to travel, a Shanghai vaccine expert said.

Stateside, President-elect Joe Biden and incoming First Lady Jill Biden plan to receive Pfizer’s coronavirus vaccine on live television Monday morning. Plus, Johnson & Johnson could file its vaccine for approval in the U.S. by January, the Department of Health and Human Services’ Adm. Brett Giroir said.

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And a new strain of the coronavirus found in the U.K. is spreading quickly, with cases reported in Italy and Australia.

The worldwide case count passed 76.92 million Monday morning, with more than 1.69 million reported deaths, according to Johns Hopkins University’s COVID-19 dashboard.

Please read below for the latest updates. Daily COVID-19 tracker entries from Aug. 11 to Oct. 30 can be found here. Entries from April 21 through Aug. 11 are here. Entries from Jan. 30 through April 20 are here.

UPDATED: Monday, Dec. 21 at 9:05 a.m. ET

The FDA on Friday cleared Moderna’s mRNA vaccine for emergency use in people ages 18 and older, teeing up immediate, nationwide distribution for the United States’ second authorized COVID-19 shot. Moderna plans to deploy 20 million doses to the U.S. by year-end, while Pfizer, first to authorization, has pledged 25 million doses. Both companies say they’re on track to deliver 100 million doses by the end of the first quarter, while Moderna recently agreed to supply 100 million more shots in the second quarter. Story

The EMA’s Committee for Medicinal Products for Human Use (CHMP) on Monday vouched for the conditional marketing authorization of Pfizer and BioNTech’s mRNA vaccine in people ages 16 and older in Europe. The European Commission is set to review and potentially rubber stamp the CHMP’s decision “in the near future,” Pfizer and BioNTech said in a release. If the Commission grants Pfizer’s shot a CMA, the decision will immediately extend to all 27 EU member states.

China aims to vaccinate 50 million people before February 15 — the date of the Lunar New Year, when many people are expected to travel, a Shanghai vaccine expert and former immunologist with the city’s CDC said during a teleconference with China’s National Health Commission. The country currently has five vaccine candidates in late-stage testing.

President-elect Joe Biden and incoming First Lady Jill Biden will receive Pfizer’s vaccine on live television Monday morning. Meanwhile, Vice President-elect Kamala Harris plans to get her shot after Christmas, on the advice of doctors who suggested she and Biden stagger their first injections. Last week, Vice President Mike Pence became the highest-ranking elected U.S. official to receive the vaccine when he, Second Lady Karen Pence and Surgeon General Jerome Adams rolled up their sleeves to get Pfizer’s shot — also on live T.V.

With authorizations for Pfizer and Moderna’s vaccines locked in, Johnson & Johnson is the next likely contender to apply for approval stateside, Adm. Brett Giroir, assistant secretary at the Department of Health and Human Services, told ABC News. J&J is expected to submit its adenovirus hopeful for authorization in January, Giroir said. The drugmaker last week said it had finished recruiting for its phase 3 trial and aims to deliver early efficacy data by the end of next month.

A new strain of COVID-19 first detected in the U.K. spreads quickly, and work is underway to determine whether it leads to higher mortality, too, Chris Whitty, England’s Chief Medical Officer, said in a statement Saturday. “As a result of the rapid spread of the new variant, preliminary modeling data and rapidly rising incidence rates in the South East, the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) now consider that the new strain can spread more quickly,” he said.

Italy on Sunday reported it had one patient infected with the new strain of the coronavirus found in Britain. The patient, now in isolation, recently returned from a trip to the United Kingdom, Italy’s health ministry said. Meanwhile, Australia on Monday confirmed it had identified two patients infected with the new strain.

UPDATED: Friday, Dec. 18 at 3:20 p.m. ET

Belgium’s budget state secretary, Eva De Bleeker, tweeted — and then deleted — the prices the European Union has negotiated for Pfizer and Moderna’s vaccines, The New York Times reports. Pfizer’s shot, due for a European approval decision Monday, will cost €12 ($14.70) per dose, bringing up the cost for a full two-dose course to €24 ($29.38). Moderna’s shot will cost $18 per dose, or $36 for a full course, according to the leaked price list.

The National Institutes of Health kicked off dosing in sub-studies of GlaxoSmithKline and Vir Biotechnology’s antibody hopeful, plus a two-antibody combo from Brii Biosciences. To start, researchers will test the two drug regimens against placebo in 450 subjects hospitalized with mild-to-moderate COVID-19. An initial readout, expected five days after dosing, will look at a range of factors like symptoms, how easily patients can perform daily activities and risk of death. If the drugs fare well, they’ll move into 700-subject trials that include patients with more severe COVID-19. Story

The FDA authorized a new version of Abbott’s speedy BinaxNOW antigen test that people can use at home with a prescription. Users aged 15 and up can take their own nose swab samples, while adults can use the swab on children as young as 4. Users are guided through the process via a telehealth connection. In partnership with digital service provider eMed, Abbott aims to deliver 30 million BinaxNOW tests by the end of March and another 90 million before the end of June. eMed, meanwhile, will pass off testing results to the relevant public health authorities. Story

COVAX, the World Health Organization’s equitable vaccine distribution scheme, has secured nearly 2 billion vaccine doses through additional supply talks with AstraZeneca and Johnson & Johnson, the alliance said Friday. COVAX aims to start deliveries in the first quarter of 2021, assuming the shots are approved. It expects enough doses in 2021’s first half to protect healthcare workers in all participating countries and economies and plans to deliver at least 1.3 billion doses to 92 low- and lower-middle income countries enrolled in the program sometime next year.

The vaccination will be televised. Vice President Mike Pence, second lady Karen Pence and Surgeon General Jerome Adams rolled up their sleeves to get Pfizer’s vaccine on live television Friday morning, making Pence the highest-ranking elected U.S. official to get the shot. After receiving the vaccine, Pence said he hoped the move would “affirm to the American people that hope is on the way,” adding that he “wanted to step forward and take this vaccine to assure the American people that while we cut red tape, we cut no corners.”

UPDATED: Friday, Dec. 18 at 11:45 a.m. ET

The FDA’s panel of vaccine experts voted 20–0 Thursday, with one abstention, that the benefits of Moderna’s mRNA shot outweigh the risks for people 18 and older. With Moderna’s vaccine now positioned for a swift authorization, panelists did raise concerns that an emergency nod could disrupt the company’s ongoing trial. Others pointed to cases of facial paralysis — a condition known as Bell’s palsy — that cropped up during the study. The FDA is investigating the side effect but “has no basis to conclude a causal relationship” between the paralysis and the vaccine, an agency official said. Story

The European Commission tapped its option to purchase another 80 million Moderna vaccine doses, raising the bloc’s total purchase to 160 million doses. Moderna aims to kick off deliveries to Europe in early 2021, subject to regulatory approval. The European Medicines Agency’s scientific committee for human medicines is set to review the shot on Jan. 6, and then the European Commission will decide whether to authorize it.

Johnson & Johnson on Thursday said it had wrapped enrollment for its late-stage vaccine trial and expects to release initial efficacy data by the end of January. If all goes to plan, J&J aims to submit its vaccine to the FDA in February and apply for authorization in other countries “in parallel.” The phase 3 kicked off in September, with study sites up and running in the U.S., South Africa, Brazil, Argentina and several other Latin American countries. Meanwhile, Health Canada launched a rolling review of the vaccine late last month.

A healthcare worker in Alaska suffered flushing and shortness of breath 10 minutes after receiving Pfizer’s vaccine, the states’ health department said. She had no previous history of allergies and is now in stable condition. Meanwhile, a second staffer at the same Alaskan hospital was hit with eye puffiness, lightheadedness, and scratchy throat ten minutes after receiving the shot, though this second case was not considered anaphylaxis.

Regeneron’s antibody cocktail successfully reduced viral load and the need for medical visits in non-hospitalized, recently-infected COVID-19 patients, with the greatest benefit seen in those who’d yet to mount their own effective immune response or had high viral load at baseline, initial data from a phase 1/2/3 trial published in the New England Journal of Medicine showed. Regeneron’s cocktail won an emergency nod in late November to treat non-hospitalized, mild-to-moderate patients at high risk for progressing to severe COVID-19.

Speaking of Regeneron, President Donald Trump personally stepped in to help Housing Secretary Ben Carson get the drugmaker’s antibody cocktail after he was hospitalized with COVID-19 last month, Carson told Fox News. Carson initially tried to treat himself with oleander extract — an unproven treatment derived from a toxic plant, which Trump and MyPillow executive Mike Lindell pushed aggressively over the summer.

UPDATED: Thursday, Dec. 17 at 3:39 p.m. ET

After HHS secretary Alex Azar said Pfizer was having some issues with its COVID-19 vaccine production, the company refuted the statement on Thursday. Pfizer “is not having any production issues” and “no shipments containing the vaccine are on hold or delayed,” the company said. At a press event Wednesday, Azar said the government had “recently been informed by them, finally, of various challenges” in the manufacturing process. Story

The United States’ second COVID-19 vaccine could be nearing an FDA emergency authorization. On Thursday, an advisory committee met to discuss Moderna’s application, with C-SPAN streaming the event. A vote on whether to recommend Moderna’s vaccine was expected around 5:15 p.m. ET.

Meanwhile, the effort to scale up COVID-19 vaccines is affecting other medicines in the pharmaceutical supply chain. Horizon said its thyroid eye disease med Tepezza will run scarce from the end of the month into 2021 as its contract manufacturer Catalent helps with coronavirus vaccine production. Story

Throughout the pandemic, market watchers have wondered whether the pharmaceutical industry would see major reputation gains. A new study in the U.K. from Takeda finds that’s not the case, as only 17% of adults surveyed in October said their perception of the industry had improved. Story

UPDATED: Thursday, Dec. 17 at 11:23 a.m. ET

Vials of Pfizer’s vaccine, designed to hold five doses, contain enough product for pharmacists to squeeze out a sixth or seventh dose, Stat News first reported. Without clear manufacturer or regulatory approval, that extra supply has so far been discarded. Now, the FDA is suggesting healthcare workers “use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue,” an agency representative told Reuters.

Speaking of Pfizer, why hasn’t CEO Albert Bourla taken the drugmaker’s vaccine yet? “I’m 59 years old, in good health, I’m not working on the frontline, so my type it is not recommended to get vaccination now,” he told CNN, suggesting it would “set a bad example” to “cut the queue.”

Japanese health authorities have questions about the efficacy of Fujifilm’s flu med Avigan in COVID-19, Kyodo News reported. Fujifilm started seeking approval in October after late-stage data showed its antiviral sped recovery time in patients with less-severe symptoms. Japan’s drug regulator is due to make a decision on Dec. 21, though it’s concerned doctors involved in the trial were aware which patients got the drug or placebo, government sources told Kyodo.

Utah’s Intermountain Healthcare says it’s trained a dedicated team, dubbed “the MAb Squad,” to contact high-risk individuals the moment they receive a positive COVID-19 testing result, helping connect them with infusion centers to receive Eli Lilly and Regeneron’s monoclonal antibody drugs. Demand for the companies’ antibodies, which must be administered soon after a person contracts COVID-19, has been underwhelming, Operation Warp Speed’s Moncef Slaoui said Wednesday.

Some 15,000 people in Moscow have received Russia’s Sputnik V vaccine since the the country kicked off large-scale vaccination efforts on Dec. 5, but enthusiasm for the shot has been mixed, the Los Angeles Times reports. Russia approved its shot this summer before wrapping up late-stage trials. It has since kicked off a phase 3, though public confidence may already be damaged. An October poll from the country’s Levada Center found 59% of Russians were unwilling to get the shot, with many wary that the “raw” vaccine was rushed to secure a world-first approval.

UPDATED: Wednesday, Dec. 16 at 3:15 p.m. ET

Most U.S. doses of Regeneron and Eli Lilly’s antibodies remain unused, Operation Warp Speed chief Moncef Slaoui told CNBC. Of some 65,000 total doses shipped out each week, only 5% to 20% end up reaching patients, he said. Some hospitals say they’re too overwhelmed to handle the logistics of prioritizing patients for treatment. As The Verge points out, patients also have a narrow window of time — soon after contracting COVID-19 — when they could benefit from Lilly and Regeneron’s drugs.

A lab technician at a Sanofi vaccine plant in Swiftwater, Pennsylvania, sued the company and the staffing firm Yoh for failing to deliver pandemic hazard pay as promised. A project manager this spring emailed more than 60 technicians to offer a 15% pay bump for the duration of the pandemic as compensation for “increased risk of exposure,” but as the weeks went on, employees noticed their wages hadn’t increased, the lawsuit alleges. The staffers were ultimately offered three extra days paid time off, the suit says, which the same manager later told them was “in lieu of hazard pay.” Story

The FDA cleared Ellume’s over-the-counter, home COVID-19 test for emergency use. The Ellume COVID-19 Home Test detects fragments of proteins of the coronavirus from a nasal swab and uses an analyzer that connects with a smartphone app to help users perform the test and interpret results. Ellume expects to crank out some 3 million tests by next month and 20 million by the second half of 2021. Story

Data analytics firm nference picked up $60 million in a series C funding round, building on a previous $60 million it raised in January. With the new cash, the company says it will to broaden its focus to include “biomedical data analytics to better understand the novel coronavirus.” This includes nference’s recent project to demystify COVID-19 transmission, the symptoms and progression of the disease and “diagnostic predictions of chronic and life-threatening conditions such as pulmonary hypertension,” the company said. Story

French shot developer Valneva kicked off a phase 1/2 trial of its inactivated, adjuvanted vaccine hopeful. The vaccine leverages the manufacturing platform of the company’s approved Japanese encephalitis shot, Ixiaro, Valneva said in a release. To start, the company will study the safety and immunogenicity of three dose levels in around 150 healthy adults at sites across the U.K. Valneva aims to pick an optimal dose by 2021’s second quarter and, if all goes to plan, believes it could snare an initial approval as early as the end of next year.

British American Tobacco — well-known for its cigarette brand Lucky Strike — bagged U.S. approval to run in-human trials of a COVID-19 vaccine made using tobacco plants, The Guardian reports. The company’s biotechnology division, Kentucky BioProcessing (KBP), says it can turn tobacco crops into “bio-manufacturing factories” by inserting a potential antigen into the plants for reproduction. The company’s unusual approach could be faster, too: up to 3 million “factory” plants can be grown, harvested and processed within six weeks, KBP said.

UPDATED: Wednesday, Dec. 16 at 9:31 a.m. ET

Pfizer is in talks with the U.S. government to free up supplies for extra vaccine doses, The New York Times reports, citing sources close to the matter. Pfizer may be able to manufacture more shots for the U.S. — beyond the 100 million it’s pledged to deliver by March — if the government orders its suppliers to prioritize its purchase requests. The company is now hashing out a contract with the government to potentially provide more doses from April to the end of June, NYT said. Story

White House press secretary Kayleigh McEnany on Tuesday said the Trump Administration was angling for an additional 100 million Pfizer doses, but didn’t specify when the order might arrive. Pfizer “can provide” the doses, CEO Albert Bourla told CNN earlier this week, but he added that “most of that we can provide in the third quarter.” The two parties are working “collaboratively” to find ways to produce more doses in the second quarter, he said.

Meanwhile, the Trump Administration turned down an offer to secure more Pfizer doses as recently as November, former FDA commissioner and Pfizer board member Scott Gottlieb said on CNBC’s Squawk Box. “I think hopefully we’ll find a way to increase supply and be able to get the government what the government needs,” he said.

BioNTech will supply 100 million vaccine doses to China as part of an agreement with the country’s Shanghai Fosun. The company will source the initial shipment from its production facilities in Germany. BioNTech and Fosun first teamed up in March to develop and commercialize a shot using BioNTech’s mRNA platform. The companies kicked off a phase 2 trial of the vaccine in China in late November. Meanwhile, BioNTech and Pfizer’s vaccine already boasts an emergency nod in countries like the U.S. and the U.K.

Long Island-based Codagenix got the OK to start a phase 1 trial of its nose drop COVID-19 vaccine in the U.K. The 48-subject trial is slated to kick off in the first week of January. Codagenix’s candidate, COVI-VAC, is designed to work after one dose and “may induce a more robust immune response and long-lasting cellular immunity,” the company said.

The University of California, San Francisco, is set to receive its first allocation of Pfizer doses in mid-December — but that’s just the start of the journey, Desi Kotis, chief pharmacy executive at UCSF health, told Fast Company. Once the university starts vaccinating people, it will send the CDC and the California Department of Public Health an accountability log of the number of doses administered each day. Meanwhile, the school is working with ethicists, doctors and health equity experts to determine who should receive the first doses.

The drug manufacturing industry in Bihar, India, is having a rough go of it amid the pandemic, and the government seems unwilling to help, Pharmabiz reports. The coronavirus has spurred losses of production, revenue and employment in the industry. Earlier this year, drug manufacturing facilities in Baddi, Himachal Pradesh, India, shut down after the region was declared a COVID-19 containment zone.

Amid pandemic supply constraints, South Africa is facing shortages of lithium, used to treat bipolar disorder, and the injectable contraceptives Depo-Provera and Nur-Isterate, made by Aspen Pharmacare and Bayer, respectively, Ruth Dube, project coordinator at the Stop Stockouts Project — a non-profit that looks to end medication scarcity — told Bloomberg. Meanwhile, Pfizer in September stopped South African manufacturing of intramuscular haloperidol, used to treat mood disorders, for “reasons beyond its control,” the company’s South African communications chief said.

UPDATED: Tuesday, Dec. 15 at 3:15 p.m. ET

Eli Lilly’s antibody treatment bamlanivimab and its immunology med Olumiant could add up to $2 billion in COVID-19 sales this year, the drugmaker said Tuesday. Pandemic profits, plus strong demand for several core products like Lilly’s diabetes drug Trulicity and its psoriasis med Taltz prompted the company to hike its year-end revenue forecast to $24.2 billion to $24.7 billion. In 2021, Lilly predicts revenues will fall between $26.5 billion to $28 billion. Story

The U.S. government should invest in production of Eli Lilly and Regeneron’s pandemic antibodies as an “insurance policy” against COVID-19 next year, former FDA chief Scott Gottlieb wrote in The Wall Street Journal. The government could pay companies for access to their manufacturing space and help blunt the risks for those willing to become contract manufacturers for the treatments, he said. The government should also stockpile raw ingredients for the drugs at a “worthwhile” price, shoring up supplies ahead of next winter. Story

President-elect Joe Biden and Vice President-elect Kamala Harris should both get Pfizer’s vaccine — as should President Donald Trump and Vice President Mike Pence, Anthony Fauci said Tuesday. Biden and Harris should get the shot as soon as possible, Fauci said, adding that Trump, who tested positive for COVID-19 in October, should also get one since his current level of natural resistance is unclear. Trump on Sunday said he wasn’t schedule to get the shot and suggested White House staffers wait until “somewhat later in the program” to receive one.

As shot authorizations start to trickle in, 71% of Americans say they would get a COVID-19 vaccine if it were free and proven safe and effective — up from 63% in September, a new Kaiser Family Foundation survey found. Twenty-seven percent of the public remains vaccine hesitant, with skepticism highest among republicans at 42%. Among Black adults — a group hit disproportionately hard by the pandemic — 35% said they definitely wouldn’t or probably wouldn’t get vaccinated. The poll surveyed 1,676 people between Nov. 30 and Dec. 8.

The U.S. Defense Advanced Research Projects Agency (DARPA) awarded a $37.6 million grant to Inovio, the Wistar Institute, AstraZeneca, the University of Pennsylvania and Indiana University to leverage Inovio’s platform to develop DNA-encoded monoclonal antibodies (dMAb) against SARS-CoV-2. To start, Inovio and Wistar will construct dMAb candidates mirroring the recombinant antibodies AZ has already pushed into clinical studies.

Biogen’s ill-fated management conference has been linked to hundreds of thousands of coronavirus cases, researchers estimate in an article published in Science. As of Nov. 1, at least one viral variant that may have hitched a ride over from Europe with an attendee had made its way to 245,000 people in the U.S., while another that emerged during or right after the Biogen conference reached 88,000, the researchers said. Story

Russia’s Sputnik V vaccine is 91.4% effective, interim phase 3 data published Monday by the country’s sovereign wealth fund showed. The readout covered 22,714 participants who got either placebo or the vaccine in Russia’s late-stage trial. Seventy-eight people became infected with COVID-19 across both groups. Twenty severe cases were logged in the placebo arm, while no one who got the vaccine became seriously ill.

UPDATED: Tuesday, Dec. 15 at 9:20 a.m. ET

Moderna’s mRNA vaccine won a thumbs-up from FDA staffers ahead of Thursday’s hotly anticipated advisory committee review. The agency reviewers highlighted the shot’s overall 94.5% efficacy rate, but noted that it appears to work better in patients under 65. Efficacy landed at 95.6% in that age group, compared with 86.4% for people 65 and older. The agency also vouched for the shot’s “favorable safety profile,” though many patients did experience mild side effects like injection site pain, fatigue and headaches, the FDA said. In an intriguing addendum to its own briefing documents, Moderna added its shot could prevent asymptomatic infection after one dose. Story

The European Medicines Agency aims to approve Pfizer and BioNTech’s vaccine on Dec. 23, Germany’s Bild reported. The agency would make an approval decision by Dec. 29 at the latest, an EMA spokesperson added. Meanwhile, Germany could kick off vaccination efforts over the Christmas holiday, Bild reports.

The first round of efficacy data from Johnson & Johnson’s phase 3 vaccine trial could arrive in early January — potentially teeing up an emergency nod later that month, Warp Speed chief Moncef Slaoui said. AstraZeneca’s efficacy readout is expected in late January, and the company could file for emergency use later in February, Slaoui said.

Some of Moderna’s COVID-19 vaccine documents were breached in a cyberattack targeting the European Medicines Agency, the biotech said. None of the data Moderna submitted contained identifying information on study participants and so far, there’s no evidence that any trial subjects have been ID’d, Moderna said. Last week, the EMA revealed hackers behind the same attack had accessed documents from Pfizer and BioNTech. Story

Pfizer’s shots are making their way across the U.S., CBS Philly reports. Temple University Hospital in Philadelphia expects to get 2,000 doses this week, with the goal to ultimately immunize between 7,000 and 8,000 patient-facing employees across its sites. Delaware on Monday received its first 9,000-dose shipment and will start giving the shot to frontline workers Tuesday. Meanwhile, the Cooper health system in New Jersey also plans to kick off vaccination efforts today.

All told, Pfizer’s vaccine made it to 141 out of 145 target locations in the U.S. Monday, an HHS spokeswoman told Metro US. Healthcare facilities in the island territories of American Samoa, the U.S. Virgin Islands, the North Mariana Islands and Guam are still waiting on shipments, she said. Meanwhile, severe storms expected in the U.S. this week could hamper ongoing distribution plans, Operation Warp Speed’s Gen. Gustave Perna said.

AstraZeneca removed children from a phase 2/3 study of its vaccine hopeful in the U.K., the United States clinical trial registry showed. Pfizer, Johnson & Johnson and Moderna are all testing their shots in kids to see how they work across a wider range of age groups.

The World Health Organization is in talks with Pfizer to include its shot in a global vaccine rollout, Bruce Aylward, a senior adviser at the agency, told Reuters. Aylward said he saw a “strong commitment” from Pfizer chief Albert Bourla to price shots fairly for poorer nations. Meanwhile, the agency expects to release information on additional manufacturers joining its COVAX vaccine facility in the coming weeks, he said.

Brazil’s Sao Paulo state plans to release efficacy data on Sinovac’s shot on Dec. 23, eight days later than planned, Reuters reports. That extra time will allow researchers to include data on a sample of 151 infected people, completing the analysis, the head of the state’s COVID-19 response said. Sao Paulo has set a vaccine rollout date for Jan. 25, though Sinovac’s shot has yet to win approval and has been met with frequent opposition from President Jair Bolsonaro.

China’s Sinopharm expects to have capacity to crank out 1 billion COVID-19 vaccine doses next year, Chinanews reports. The company has two inactivated vaccine candidates in phase 3 trials across 10 countries and regions, Yang Xiaoming, Sinopharm’s president, said. As it stands, Sinopharm’s plants in Wuhan and Beijing have a combined capacity of 300 million doses per year.

South Korea’s drug regulator cleared Celltrion’s experimental COVID-19 antibody treatment in patients with life-threatening disease. Under South Korea’s treatment scheme, patients with potentially fatal conditions and no other treatment options can receive drugs still in clinical trials, the Ministry of Food and Drug Safety said. Celltrion’s antibody is currently in phase 2 and phase 3 studies. The company plans to pursue an emergency nod before the end of the year.

A new strain of the coronavirus surfaced in the U.K., with more than 1,000 cases of the new variant found “predominantly in the South East” Monday, health secretary Matt Hancock said. Dubbed VUI-202012/01, the strain has also been identified in Wales. The new variant is spreading faster than the existing coronavirus strain, but it’s too early to say how it will affect the virus’ overall behavior, Hancock said. The mutation can still be detected by COVID-19 tests, another official added.

UPDATED: Monday, Dec. 14 at 3:05 p.m. ET

The U.S. government on Monday tapped its option to buy an additional 100 million doses of Moderna’s vaccine for around $1.68 billion, raising the country’s total order to 200 million doses — enough to vaccinate 100 million people. The biotech said it plans to distribute the new order in 2021’s second quarter. Ahead of that, it plans to ship out some 20 million doses this month and deliver 80 million more by next year’s first quarter, provided it wins an FDA emergency nod. Story

Vaccinations with Pfizer’s shot kicked off in the U.S. Monday, less than 11 months after the country’s first COVID-19 case, but the nation isn’t out of the woods yet, SVB Leerink analysts pointed out. Shot hesitancy among the public is one major concern, with recent reports of anaphylaxis and Bell’s palsy after vaccination adding to those worries, the analysts wrote. Supply and storage could create additional hurdles, while R&D setbacks for Sanofi, GSK and AstraZeneca may limit the U.S.’ backup options behind Pfizer and Moderna’s shots. Story

Eli Lilly’s Olumiant (baricitinib) plus Gilead’s Veklury — also known as remdesivir — may work better than Veklury alone in hospitalized COVID-19 patients on high-flow oxygen or non-invasive ventilation, a study published in the New England Journal of Medicine found. Among that group, patients who got the combination treatment had a median recovery time of 10 days, compared to 18 days in the group that received solo Veklury.

Eureka Therapeutics’ antibody nasal spray InvisiMask protected mice against SARS-CoV-2 pseudovirus for at least 10 hours, even at the lowest concentrations tested, researchers described in a paper on bioRxiv. The drug could work as a daily preventive measure against COVID-19, said Eureka, which is currently working on a clinical trial application with the FDA. Eureka’s monoclonal antibody targets the virus’ spike protein and has been further modified to increase its binding to mucin — a bid to extend the retention time of the drug in the respiratory tract. Story

In a preclinical trial, ImmunityBio’s oral COVID-19 vaccine raised levels of anti-spike antibodies in almost all 10 nonhuman primates who received the candidate. Five primates got subcutaneous doses on days 0 and 14, followed by an oral tablet on day 28. The other five received a subQ primer dose to start, but switched to the oral formulation for the two boosters. The company plans to move the oral formulation into phase 1 testing alone and as a boost to a subcutaneous shot in a mixed regimen. Immunity launched a phase 1 trial of its injectable formulation in October. Story

A finger-worn sensor from Oura may help reliably detect an oncoming fever before a person feels the effects, a proof-of-concept study showed. The results could position the device as an early warning system for spotting a major symptom of COVID-19, researchers running the Oura-funded study said. Data were gathered from a group of 50 participants who reported contracting COVID-19 and are the first to be published out of a larger, 65,000-subject trial of the Oura ring. Story

Parisian diagnostics firm Novacyt launched a research-use-only polymerase chain reaction (PCR) test for a new strain of COVID-19. The test homes in on the Y453F viral mutation originally found in mink in Denmark and the Netherlands. The mutation quickly spread to humans and has been detected outside of Europe. Story

Top U.S. infectious disease expert Anthony Fauci stars in the first phase of the Department of Health and Human Services’ troubled, $250-million ad campaign to build public confidence in a vaccine. The first video in the $500,000 “Tell Me More” digital campaign opens with reassurance from Fauci that the pandemic will end, while additional videos detail the science behind the virus and vaccine development. The effort will be followed by a $36.6 million “Slow the Spread” radio campaign, set to debut Dec. 21. Story

Primary care doctors in the U.K. will start offering doses of Pfizer and BioNTech’s vaccine to their patients, a little less than a week after the country started rolling out the shot, The New York Times reports. As of Monday, vaccines are being deployed to more than 100 vaccination sites, while more doctors and pharmacies are set to join the program on a “phased basis” over the next few months, the country’s National Health Service said.

UPDATED: Monday, Dec. 14 at 11:45 a.m. ET

It’s official: The FDA Friday cleared Pfizer and BioNTech’s mRNA shot, authorizing the first COVID-19 vaccine for emergency use in the U.S. The nod came a little more than 24 hours after the FDA’s Vaccines and Related Biologics Products Advisory Committee voted 17–4, with one member abstaining, that the vaccine’s benefits outweigh the risks in people over the age of 16. Story

As of Monday morning, patients started receiving Pfizer’s shot at the Long Island Jewish Medical Center in Queens, New York, The New York Times reports. Across the U.S., 145 sites are expected to receive vaccine shipments today, followed by 425 sites on Tuesday and 66 Wednesday, Operation Warp Speed’s Gen. Gustave Perna said.

Speaking of vaccinations, President Donald Trump Sunday said he would delay plans for senior White House staffers to receive the vaccine in the coming days, The New York Times wrote. The move came hours after The Times reported on the administration’s plan to distribute the shot internally. “People working in the White House should receive the vaccine somewhat later in the program, unless specifically necessary,” the President tweeted.

FedEx, United Airlines and UPS are taking to the skies to fly the first Pfizer doses to vaccination centers around the country. United says it was the first commercial airline to ferry Pfizer’s shot to the U.S. FedEx, meanwhile, will transport the vaccine using its priority overnight service, while UPS plans to move the shot from Pfizer storage sites in Michigan and Wisconsin to its UPS Worldport facilities in Louisville, Kentucky, where it will then expedite the shots to hospitals, clinics and other medical facilities.

Novartis and Incyte’s JAK1/JAK 2 inhibitor Jakafi, also known as ruxolitinib, missed the mark in a phase 3 study to see whether it could help patients aged 12 years and older with COVID-19-related cytokine storm. By day 29 of the study, there was no reduction in the proportion of patients on Jakafi and standard of care who experienced severe complications, including death, respiratory failure or admission to an ICU, compared to those on standard care alone, Incyte said. The drug also failed to improve mortality rates or time to recovery by day 29.

AstraZeneca would have run the University of Oxford’s vaccine trials differently if it had been in charge, Mene Pangalos, VP, biopharmaceuticals R&D at the British drugmaker, told BBC Panorama. Two full-doses of AstraZeneca’s vaccine have so far proven around 62% effective, while a regimen including half-dose primer shot charted 90% efficacy in phase 3, leading to recent confusion around the vaccine’s benefit. Ultimately, “it is what it is,” and AZ and Oxford have done as good a job as possible to set themselves up for a potential approval, Pangalos said.

Germany’s CureVac kicked off a phase 2b/3 trial of its mRNA vaccine candidate, CVnCoV. The trial will enroll 36,500 participants in Europe and Latin America with a view to generate data for a possible 2021 authorization. Unlike Moderna’s mRNA shot, advanced at a 100-microgram dose, CureVac’s candidate triggers immune responses at just 12 micrograms, enabling the company to pump out more doses if it snares approval. The phase 2b will generate safety, reactogenicity and immunogenicity data to inform the phase 3 start. Story

Even with Pfizer’s shot authorized and a possible Moderna EUA on the horizon, the worst of the pandemic is still yet to come, Bill Gates told CNN Sunday. “Sadly the next four to six months could be the worst,” the Microsoft co-founder warned. A vaccine won’t be widely available until spring or summer. “In the near term, it’s bad news,” Gates said, citing an evaluation showing the U.S. could suffer more than 200,000 additional COVID-19 deaths by April 1.

Swiss biotech Relief Therapeutics, partnered with the U.S.’ NeuoRx on development of a patented version of aviptadil for COVID-19 respiratory failure, has seen its share price skyrocket by 38,000% this year, CNBC reports. The companies have been in contact with Operation Warp Speed, and if their treatment passes muster in phase 3, the partners expect to receive stockpiling orders on par with those for Gilead Sciences’ antiviral Veklury and Eli Lilly’s monoclonal antibody bamlanivimab, Relief chairman Ram Selvaraju told the news outlet.

UPDATED: Friday, Dec. 11 at 3:15 p.m. ET

With an emergency use authorization looming, Pfizer is already looking ahead with plans to file its vaccine for a full FDA approval by April, William Gruber, SVP of vaccine clinical research and development at the company, said.

Roche has started deploying its Elecsys high-throughput antigen test across Europe, which could ease the burden on molecular-based diagnostics — the gold standard since the pandemic’s start. Anticipating international demand next year, Roche aims to boost production to “a double-digit million number of tests per month.” The test uses deep nose or throat swabs collected by healthcare professionals and runs on the company’s cobase immunochemistry analyzers, at up to 300 tests per hour. Story

The World Health Organization could offer a decision on Pfizer’s vaccine within a “couple of weeks,” Soumya Swaminathan, chief scientist at the agency, told Reuters. It may also review Moderna and AstraZeneca’s vaccines in a similar timeframe, she added. A WHO authorization could potentially allow vaccines to reach countries where local regulators have not yet had the chance to review them.

Sorrento Therapeutics got a thumbs up to run a phase 1 trial of its next-generation antibody treatment, STI-2020, also known as COVI-AMG. The drug is a new-and-improved version of the company’s first-gen antibody treatment COVI-GUARD, for which Sorrento has yet to publish phase 1 clinical data. To start, Sorrento will evaluate the safety, pharmacokinetics and efficacy of the drug at a single dose in healthy and non-hospitalized patients with mild COVID-19.

Teva teamed up with Villyge family benefits to help its employees better cope with work-life stresses, amplified by the COVID-19 pandemic. The partnership will result in a four-part virtual workshop series to help parents better manage work and family needs. As stay-at-home orders and school closures upend business-as-usual for working parents, women especially have had to shoulder the burden. More than 2.2 million women left the workforce between February and October due to pandemic disruptions, Teva noted in a press release. Story

The World Trade Organization Thursday considered waiving certain intellectual property rights for COVID-19 drugs, vaccines and tests — a move supported by India and South Africa, plus organizations like Médecins Sans Frontières. But those patent protections drive innovation, Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, wrote in a New York Times op-ed. Without the potential for financial reward, drugmakers wouldn’t invest years — and billions — into the development of new meds, he said.

Thirty-five percent of women say they’re “not very” or “not at all” interested in getting a COVID-19 vaccine, up nine percentage points from May, a Reuters and Ipsos poll found. Among that group, 60% said they were wary of the rapid fire development and approval process. Meanwhile, 68% of men and 55% of women said they would consider getting the vaccine. Convincing more women to accept the shot could be crucial to early vaccination efforts, as American mothers make some 80% of healthcare decisions for their families, according to the U.S. Department of Labor.

Russia kicked off a mass vaccination campaign with its Sputnik V shot this week, but initial turnout has been lower than expected, The Washington Post reports. Some of that hesitancy could stem from the shot’s swift registration over the summer, before it completed trials. Even now, Sputnik V is still in late-stage testing, and Russian scientists have so far only published phase 1/2 results. In an October poll by the Levada Center, 59% of Russians said they wouldn’t get a vaccine, while a separate, government-backed survey that same month found 73% were unwilling to get the shot.

UPDATED: Friday, Dec. 11 at 9:14 a.m. ET

The FDA’s expert panel Thursday voted 17–4, with one member abstaining, that the benefits of Pfizer and BioNTech’s vaccine outweigh the risks for use in people 16 and older. Some panelists raised concerns about the relatively low number of 16- to 17-year-old trial participants, however, and at least a few wanted to exclude this age group from the emergency use authorization. Panelists also discussed allergic reactions that hit two U.K. healthcare workers who received the vaccine, as well as the novelty of the drugmakers’ mRNA platform. Story

Interim phase 1/2 data showed Sanofi and GlaxoSmithKline’s vaccine candidate spurred an adequate immune response in people aged 18 to 49 years — but the vaccine failed to trigger a comparable response in older adults. The setback triggered a new phase 2b trial and stands to delay the recombinant protein shot from mid-2021 to near the end of next year. The partners pegged insufficient concentrations of the adjuvant, supplied by Sanofi, as the likely cause of the lackluster data. They plan to launch a test of a new antigen formulation in February. Story

On the heels of Pfizer’s panel review, the U.S. is planning to authorize the shot — which could go out to the public by Monday or Tuesday of next week, HHS secretary Alex Azar told ABC’s Good Morning America. The FDA on Friday issued a statement saying “it will rapidly work toward finalization and issuance of an emergency use authorization” following Thursday’s meeting.

By year-end, AstraZeneca plans to kick off a trial combining its vaccine with Russia’s Sputnik V shot, the Russian Direct Investment Fund said. The hope is that by combining the two adenovirus vaccines, AstraZeneca’s candidate — troubled in recent weeks by less-than-stellar data — could enjoy an efficacy boost. Meanwhile, Russia said it wants to jointly produce the new vaccine if it passes muster in the clinic.

Australia’s CSL put the kibosh on mid- and late-stage trials of a vaccine in development with the University of Queensland after the shot triggered an antibody response that led to false positives on some HIV tests, the company said. Instead, CSL has signed on to manufacture another 20 million doses of AstraZeneca’s vaccine on top of the 30 million doses it’s already agreed to crank out. Plus, the company said it will still keep its phase 1 vaccine trial going.

Rumors that Pfizer and BioNTech’s mRNA vaccine could cause infertility in women flooded social media this week — but that simply isn’t true, health experts told The New York Times. A blog post compared the virus’ spike protein with a type of placental protein, which it alleged were similar enough to trick the body into attacking the placenta. But those proteins are almost nothing alike, an expert in maternal and neonatal immunity at Duke University told the Times. Pfizer, meanwhile, pointed to a recent study showing its vaccine didn’t appear to raise the risk of pregnancy-related problems.

UPDATED: Thursday, Dec. 10 at 3:25 p.m. ET

The U.S. could meet its goal to vaccinate every American by summer if it backs up its Pfizer and Moderna doses with vaccines from AstraZeneca and Johnson & Johnson, Warp Speed chief Moncef Slaoui said. Phase 3 data on the companies’ viral vector vaccines are expected by February, he said, voicing confidence that both would succeed. The shots’ proven technology would make them easier to scale up than mRNA candidates, too, Slaoui added. AZ and J&J are expected to provide between 150 million to 200 million doses total in 2021’s first quarter. Story

Moncef Slaoui played matchmaker in Merck’s recent $425 million buyout of OncoImmune, Bloomberg reports. The company is developing a non-antiviral immunomodulator, CD24Fc, which has shown promise in patients hospitalized with severe COVID-19. After seeing positive data on the drug, Slaoui quickly phoned OncoImmune’s CEO and, two days later, Operation Warp Speed met with the company’s research team. Slaoui then sent out a slate of emails to pharma execs — hooking Merck’s research head, Roger Perlmutter.

The FDA cleared LabCorp’s Pixel test for home use without a prescription. Self-collection kits can now be bought directly through the company’s website by anyone over the age of 18 for the price of $119 out-of-pocket. After swabbing the the inside of the nose, the sealed sample is shipped overnight to a lab for analysis, with results typically delivered within one to two days. LabCorp will also use its online portal to connect users who test positive with a healthcare provider, supporting treatment and isolation. Story

CDC official Charlotte Kent, who edits the agency’s Morbidity and Mortality Weekly Report, told House Democrats she was ordered to destroy an email from a Department of Health and Human Services staffer who tried to meddle in the report’s publication. Kent’s allegation stems from an August email from then-senior HHS adviser Paul Alexander, who asked her to put new language into an earlier report on COVID-19 risks to children or “pull it down and stop all reports immediately.”

In some 70 developing nations, only one in 10 people is expected to receive a COVID-19 vaccine next year, the People’s Vaccine Alliance warned, urging drugmakers to share the science and technology behind their shots. Meanwhile, rich countries representing just 14% of the world’s population have snapped up more than 50% of the leading shot candidates, The New York Times reports, citing data from the London-based software company Airfinity, which looked at supply deals covering eight vaccines in phase 3 testing.

Brazil’s Sao Paulo state on Thursday started producing Sinovac’s COVID-19 vaccine hopeful, Governor João Doria said. The state’s Butantan Institute has capacity for 1 million doses of CoronaVac per day, he said. Sao Paulo plans to kick off vaccination efforts on Jan. 25, despite President Jair Bolsonaro’s repeated objections to the Sinovac shot. Meanwhile, the country’s health minister Thursday pledged to vaccinate Brazil’s entire population against COVID-19 in 2021.

UPDATED: Thursday, Dec. 10 at 9:36 a.m. ET

Moderna dosed the first teenagers in a 3,000-subject, phase 2/3 trial to see whether its mRNA shot works in that age group. Moderna aims to deliver that data by spring 2021, hoping for an expanded approval ahead of the school year. The study’s size and the low rate of symptomatic COVID-19 in adolescents may hinder Moderna’s efforts to deliver data in time, though. Story

The brouhaha surrounding Warp Speed’s Pfizer vaccine purchase continues. The government expects to receive all of its initial order by March, and it still has the option to purchase another 500 million doses after that, HHS Secretary Alex Azar told PBS Newshour. But former FDA commissioner and Pfizer board member Scott Gottlieb maintains that government “multiple times” turned down offers to purchase more shots than it did initially and may have missed its chance to secure another order before July, Gottlieb told CNBC.

Meanwhile, documents linked to Pfizer’s vaccine submission in Europe were unlawfully accessed in a recent cyberattack targeting the European Medicines Agency. Neither Pfizer nor BioNTech’s own systems was breached, and as far as the companies know, no trial participants were ID’d. The attack should have no bearing on the timing of the partners’ vaccine review, the companies added. Story

Plus, the FDA’s vaccine advisory committee takes its deep dive into Pfizer and BioNTech’s mRNA shot Thursday and weigh in by day’s end on whether the FDA should issue an emergency green light. Meanwhile, the CDC’s Advisory Committee on Immunization Practices will meet Friday and Sunday to hash out who should receive the first doses.

AstraZeneca’s shot has a “distinct comparative advantage” over its rivals, Richard Horton, editor-in-chief of The Lancet, said. For one thing, it can be easily stored and distributed across low- and middle-income countries, he figures. Unlike Pfizer’s shot, which must be kept at minus 94 degrees Fahrenheit, AZ’s vaccine can be stored at regular refrigerator temps. Plus, Horton said, it’s cheaper than its rivals.

Rudolph Giuliani, personal lawyer to President Donald Trump and the latest member of his inner circle to test positive for COVID-19, was treated with Eli Lilly’s monoclonal antibody bamlanivimab and Regeneron’s antibody cocktail, he told WABC radio. Meanwhile, across the nation, antibody treatments are so scarce that states have developed systems for rationing their use, The New York Times reports.

South Africa will leverage rolling reviews to fast track approval of COVID-19 vaccines, the country’s drug regulator, SAHPRA, told Reuters. It expects to receive its first set of applications within two weeks and hopes to receive its first doses from the World Health Organization’s COVAX distribution scheme in the second quarter of 2021.

UPDATED: Wednesday, Dec. 9 at 3:03 p.m. ET

Canada Wednesday became the third country to authorize Pfizer and BioNTech’s mRNA vaccine, paving the way for a shot rollout as early as next week. Pfizer will supply Canada with up to 76 million doses of its vaccine, a spokeswoman for the drugmaker’s Canadian unit said. On Monday, the country said it had secured early delivery of 249,000 initial doses in anticipation of vaccination efforts next week.

The European Medicines Agency said Wednesday it had been hit by a cyberattack. It’s unclear who was behind the attack or what, if any, data were compromised, though the cybersecurity scare comes as the EMA weighs approvals for vaccines from Pfizer, Moderna and AstraZeneca. Earlier this month, The Wall Street Journal reported that North Korean hackers had targeted AZ, Johnson & Johnson and Novavax, as well as three South Korean drugmakers working on COVID-19 meds.

President-elect Joe Biden aims to get 100 million Americans vaccinated during his initial hundred days in office — and that’s just the first piece of a three-part plan to overhaul the nation’s pandemic response. Biden also intends to sign a mask mandate and hopes to safely reopen the majority of American schools by the end of his first 100-day run.

As the country slaps together a piecemeal shot distribution plan, states are disagreeing on which workers qualify as essential. More than 20 industry groups representing truck drivers, teachers, retail workers and more are pushing officials to prioritize their employees. States are largely following federal guidance to protect workers in the food and meat processing industries, but some are awaiting further guidance from the CDC’s Advisory Committee on Immunization Practices.

The San Francisco Bay Area is gearing up to start vaccinations as early as next week — contingent on Pfizer’s shot winning a speedy authorization from the FDA, the San Francisco Chronicle reports. The city’s Department of Public Health expects to receive some 12,000 initial doses out of the 2.1 million set aside for California. Across the state, vaccines will first go out to healthcare employees, long-term care facility residents, first responders and dialysis workers.

Revving up for a mass vaccination program, Indonesia on Sunday received its first, 1.2 million-dose vaccine shipment from China’s Sinovac, the country’s president said. The government plans to grab another 1.8 million doses in January and is awaiting shipments of raw materials to crank out 15 million doses this month, followed by materials for 30 million more doses in January, he added. Indonesia, which hasn’t yet authorized the vaccine, started testing the shot in August.

UPDATED: Wednesday, Dec. 9 at 9:15 a.m. ET

Roche is teaming up with Moderna to include its Elecsys Anti-SARS-CoV-2 S antibody test in the biotech’s vaccine trial. Moderna will use the test to measure the immune response triggered by its mRNA shot. By providing a quantitative readout of antibody levels, the test could also help determine when or whether a patient needs revaccination, Roche figures. Story

People with a history of allergic reactions should not get Pfizer’s COVID vaccine, the U,K,’s drug regulator said. The advice came after two National Health Service (NHS) staffers reported anaphylactoid reactions linked to taking the vaccine, Reuters reports. Both are recovering well, NHS medical director Stephen Powis said. Pfizer said it’s supporting the country’s Medicines and Healthcare Products Regulatory Agency as it seeks further information on the reactions.

Meanwhile, four patients in Pfizer’s late-stage vaccine study experienced facial paralysis, prompting the need for further observation once the shot becomes widely available, the FDA said. No participants in the control group developed Bell’s palsy, though the frequency of cases was “consistent with the expected background rate in the general population,” the FDA said. Story

AstraZeneca’s vaccine could work at a single dose and prevent asymptomatic cases, but key efficacy questions remain after full late-stage data were published in The Lancet. The rate of asymptomatic infection in patients who received AZ’s half-dose primer shot landed at 0.6%, compared to 1% in the full two-dose group. But trial protocols diverged greatly between sites, with patients in the U.K. and Brazil often receiving their second doses at different intervals in the study. That could affect efficacy if lag time between the prime and booster shot matter. Story

Sinopharm’s experimental COVID-19 vaccine is 86% effective, the health ministry of the United Arab Emirates said, citing interim phase 3 data. UAE kicked off a late-stage trial of the shot in July. In September, it cleared the vaccine for emergency use in certain groups. Meanwhile, the state added that it had officially registered the shot, without clarifying whether that meant it had authorized the vaccine for wider use.

At least 110,000 doses of Pfizer and BioNTech’s vaccine are expected to arrive in Israel Wednesday, with a slate of medical workers already in line to receive the first batch, The Jerusalem Post reports. The country has purchased 8 million doses from Pfizer and could see 4 million of those arrive before year-end, though the country will wait for the shot to snare U.S. FDA approval before giving it to the public, Chezy Levy, director-general of the Israeli Health Ministry, said.

Plus, Israeli Prime Minister Benjamin Netanyahu will be the first person in the country to receive Pfizer’s vaccine, BNN Bloomberg reports. “I believe in this vaccine, I expect it to get the necessary approvals in the next few days,” Netanyahu said, adding that he wanted to set an example for other Israelis to get vaccinated.

UPDATED: Tuesday, Dec. 8 at 2:45 p.m. ET

Pfizer and BioNTech’s mRNA vaccine starts to protect against COVID-19 after the first dose, according to FDA documents published ahead of Thursday’s advisory panel meeting. The briefing docs reiterated that the shot was 95% effective after two doses. Efficacy was consistently high at 94.7% for participants over the age of 65 and 95.3% in those with underlying conditions. Story

AstraZeneca’s vaccine is safe and effective at preventing COVID-19, researchers writing for The Lancet confirmed. Average efficacy landed at 70.4%, according to pooled data on 11,636 trial subjects from the U.K. and Brazil. As AZ previously revealed, a half-dose primer shot — originally given to patients by mistake — led to 90% efficacy, while the full two-dose course was 62.1% effective. Meanwhile, the British pharma has started submitting data to regulators and its supply chains are primed and ready to deliver hundreds of millions of doses globally, CEO Pascal Soriot said.

Speaking of supply chains, AstraZeneca tapped Dutch CDMO Halix to carry out large-scale commercial drug substance manufacturing for its University of Oxford-partnered vaccine. Halix will perform the work from its facility at the Leiden Bio Science Park in the Netherlands, the company said in a release. The CDMO was one of the original partners in Oxford’s consortium to manufacture the shot, Halix added.

NeuroRx and Relief Therapeutics hit the enrollment target for a phase 2b/3 trial of their drug RLF-100, also known as aviptadil, in patients with COVID-19 respiratory failure. The drug has an FDA OK to test intravenous and inhaled versions of the therapy and snared a fast track tag, too.

An agency watchdog cleared the U.S. International Development Finance Corporation (DFC) of fault in its plan to grant Kodak $765 million to enter drug manufacturing. In a copy of the review obtained by The Wall Street Journal, the agency’s inspector general couldn’t find “any evidence of misconduct” by DFC officials, though he did take issue with the timing of the loan’s announcement. Story

California on Monday became the largest state to roll out Google and Apple’s contact tracing tech for smartphones. The app lets users’ devices communicate anonymously via Bluetooth and sends a tip to users when a recent contact tests positive.

India is weeks away from a vaccine approval, the country’s federal health secretary said. Pfizer and AstraZeneca — by way of the Serum Institute of India — both filed their shots for an Indian OK over the weekend, while domestic shot maker Bharat Biotech has also submitted its candidate, Covaxin, to regulators.

UPDATED: Tuesday, Dec. 8 at 9:20 a.m. ET

The U.K., which kicked off its vaccination drive Tuesday, is plotting a “mix and match” trial of Pfizer and AstraZeneca’s COVID-19 shots to see whether the vaccines work better as a team. The trial is pegged to start in January after AZ’s shot wins a regulatory OK. Moderna’s mRNA vaccine will also be thrown into the mix if it’s cleared by U.K. regulators, too, Kate Bingham, head of the country’s vaccine taskforce, said.

The U.S. is capped at the 100 million doses it already ordered from Pfizer until at least next June, The New York Times reports. During the supply deal’s early days, Pfizer urged Operation Warp Speed to purchase an initial 200 million doses, enough to vaccinate 100 million people, but officials rejected that offer, sources told The Times. Just recently, the U.S. approached Pfizer for additional doses, but the drugmaker explained supplies had been snapped up by other countries. Story

Which are the top 10 manufacturers in the fight against COVID-19? Already a booming industry before the pandemic, the contract manufacturing field has taken off this year as drugmakers look to scale up production and lean on specialized knowledge to get their vaccines and meds to potentially billions of patients. Fierce Pharma’s special report shows how companies such as Emergent, Serum Institute of India, Fujifilm and Phlow are pitching in. Story

The U.S. has the option to buy another 500 million Pfizer doses, Department of Health and Human Services Secretary Alex Azar reminded NBC News, but it may not be that simple. When the government passed on a larger dose order in July, Pfizer went on to ink a slate of multimillion-dose deals with the likes of Canada, the U.K. and the European Union. Now, supplies are limited, and “any additional doses beyond the 100 million are subject to a separate and mutually acceptable agreement,” the drugmaker said.

Meanwhile, The New York Times’ take on the government’s Pfizer order is “false,” a Trump administration official told CBS News. The administration is “in the middle of negotiations right now and can’t talk publicly about it,” but feels confident that every American who wants a vaccine will get one, the official said.

Plus, Canada will start receiving doses of Pfizer’s vaccine this week, with up to 249,000 doses expected by the month’s end, Prime Minister Justin Trudeau said. If the country’s drug regulator authorizes the shot this week, Canadians could start receiving vaccinations as early as next week.

Pfizer and Moderna won’t attend an upcoming White House summit meant to build confidence in vaccines, Bloomberg reports. Operation Warp Speed had originally extended an invite to several shot developers, but once a Peter Marks presentation showed up on the docket, a decision was made to keep drugmakers separate from their regulator, the news outlet said. Marks heads up the FDA center that reviews vaccines.

The FDA Tuesday released a detailed analysis of Pfizer and BioNTech’s vaccine to lay the groundwork for Thursday’s emergency authorization review — one from the FDA’s own staff and scientists, and another from the companies themselves.

Don’t throw out your masks once a vaccine is approved. While the shots from Pfizer and Moderna appear effective at preventing serious illness, the jury’s still out on whether they curb the virus’ spread, health experts told The New York Times.

UPDATED: Monday, Dec. 7 at 3:18 p.m. ET

President-elect Joe Biden tapped California Attorney General Xavier Becerra as his choice for Department of Health and Human Services Secretary, according to multiple reports. While the current Secretary Alex Azar — a former Eli Lilly exec — is seen as a friend to pharma, his replacement looks more like a critic. Early into his AG post, Becerra joined 39 other states in a federal antitrust lawsuit that accused six generic drugmakers of colluding in a price-fixing scheme. He’s also led California’s legal battle against Purdue Pharma for its role in the opioid crisis. Story

The FDA Friday approved its first at-home test kit that can detect COVID-19, plus influenza A and B. Developed by Quest Diagnostics, the test allows patients with signs of respiratory infection to collect a nasal sample and send it off to the company’s labs to differentiate between the viruses and seek appropriate care. Available by prescription, the test is intended for those over the age of 18, while adolescents and children can be swabbed with adult supervision. Story

Qiagen rolled out a new blood test to detect the activity of T-cells, which studies have shown may provide longer-term protection against the coronavirus than antibodies, the diagnostics maker said. There’s evidence to suggest T-cell responses may help predict disease severity and potential protection in COVID-19 patients post-recovery, too. Last month, Qiagen forged a COVID-19 pact with TScan Therapeutics to use the company’s genome-based, high-throughput discovery platform for T-cell receptors to develop new in-vitro lab tests. Story

Researchers in California aim to develop a CRISPR-based COVID-19 test that runs on a smartphone and delivers results in less than 30 minutes. Most current molecular tests for the disease are based on PCR, which requires the virus’ RNA to be converted into DNA and then amplified. The researchers’ approach, meanwhile, uses CRISPR proteins designed to hunt directly for the virus’ RNA, skipping those steps for swifter results. Story

Backed by an army of healthcare workers and tens of thousands of volunteers, the U.K. on Tuesday will start vaccinating the public with Pfizer and BioNTech’s COVID-19 shot — with the goal to vaccinate more than 20,000 citizens in a few months time, The New York Times reports. Under the umbrella of the country’s National Health Service, family doctors will be tasked with doling out many of the shots. Meanwhile, the country is setting up temporary vaccination sites and recruiting retired health care workers to see the massive effort through.

Meanwhile, Moscow on Saturday started distributing Russia’s Sputnik V vaccine through 70 clinics, with the aim to get shots to the country’s most exposed groups, Reuters reports. The vaccine, developed by the country’s Gamaleya Institute, will first got out to healthcare workers, teachers and social workers. The age to receive a vaccine is capped at 50. Those with underlying health conditions, pregnant women and those who’ve had a respiratory illness for the past two weeks are ineligible, the news outlet wrote.

AstraZeneca’s Chinese manufacturing partner for its COVID-19 vaccine, Shenzhen Kangtai, isn’t immune to the corruption that’s plagued many of the country’s drugmakers, The New York Times reports. A government official was jailed in 2016 for taking bribes from Shenzen’s chairmen, Du Weimin — known in some circles as the “king of vaccines.” Meanwhile, a former head of the Gates Foundation vouched for Shenzen’s vaccine know-how, but critiqued its business practices, suggesting that to sell to local governments, “they have to do kickbacks, they have to bribe.”

Canada’s AbCellera, tapped by Eli Lilly earlier this year to find the human antibody behind its recently-authorized COVID-19 drug bamlanivimab, plans to raise a hefty $357 million on the Nasdaq by offering 23 million shares at a price range of $14 to $17, with the company valued at the midpoint range at around $5 billion. The company, which uses AI to speed up drug research, in March got off a $105 million series B, partially funded by Lilly. In May, the company snared $175.6 million in support from the Canadian government. Story

UPDATED: Monday, Dec. 7 at 9:35 a.m. ET

Ahead of Pfizer’s vaccine review this Thursday, Moncef Slaoui, head of the government’s Operation Warp Speed vaccine program, plans to meet with President-elect Joe Biden to discuss the Trump administration’s distribution scheme. Biden says he’s yet to see a detailed outline of the plan, which he called expensive and difficult. Slaoui, for his part, told CBS’ Face the Nation that the government’s distribution effort is “very appropriately planned.”

If FDA commissioner Stephen Hahn were to issue an emergency use authorization for Pfizer’s vaccine candidate Thursday — the same day a panel of FDA advisers will meet to assess the shot — Americans could start receiving the vaccine in as little as 24 hours, James Hildreth, a member of the agency’s Vaccines and Related Biological Products Advisory Committee, told NBC. Meanwhile, “the minute it’s approved, the shipments will start,” Slaoui said.

It may be time to start scaring people about COVID-19, a New York Times op-ed argues. Much in the same way antismoking “scare” campaigns helped smoking rates plummet in the late 1960s and early 1970s, graphic reminders of COVID’s physical toll could offer some perspective on the costs of catching the virus. California has come closest in one recent PSA — a soft-focus video featuring the sounds of a person on a ventilator, with a voiceover appeal to mask up for the benefit of friends and family.

Bahrain, located in the Persian Gulf, became the second nation after the U.K. to approve Pfizer and BioNTech’s mRNA vaccine, a state-run news agency announced Friday. Both Pfizer and Bahrain are keeping details on the volume and timing of the country’s vaccine order close to the vest. The country previously authorized a shot from China’s Sinopharm and has so far vaccinated around 6,000 people.

Pfizer on Friday became the first company to seek emergency approval for a coronavirus vaccine in India. The country expects to have a vaccine available in the next few weeks and will kick off vaccinations as soon as a green light is granted, Prime Minister Narendra Modi said.

Meanwhile, Serum Institute of India on Monday filed for an emergency use authorization of AstraZeneca’s vaccine there, CEO Adar Poonawalla tweeted. The app made SII the second company after Pfizer to apply for a vaccine nod in-country, though AZ’s shot may be better suited to Indian distribution because it can shipped and stored at refrigerator temperatures.

Plus, India is speeding up reviews of AstraZeneca and Pfizer’s vaccine candidates, a government official said Monday. Serum Institute, producing AstraZeneca’s shot under the name Covishield in India, recently said it planned to continue testing two full doses of the vaccine after AZ revealed a half-dose primer shot might work better. With about 40 million doses already on hand, Serum Institute will first supply the Indian government, but then plans to sell 20 million to 30 million doses to private facilities there as early as March, Poonawalla told the Financial Times. The company will focus on Indian supplies before marketing the shot in other countries, pricing it at 1,000 rupees ($13.50) per dose for private markets, Poonawalla said.

Sinovac bagged $515 million from fellow Chinese firm Sino Biopharmaceutical to double capacity for its COVID-19 vaccine hopeful, CoronaVac. Sinovac expects to have capacity for 300 million doses per year, though it plans to wrap construction on a second production facility before the end of 2020 that would bump up its annual volume to 600 doses. The company has so far sold doses to Turkey, Brazil and Chile, and is in talks with the Philippines on a potential supply deal. Story

UPDATED: Friday, Dec. 4 at 3:15 p.m. ET

Antibody levels stayed elevated in the 90 days after patients received a second dose of Moderna’s vaccine candidate, updated phase 1/2 data show, raising hopes that the vaccine could offer longer-term protection. Researchers noted a slight drop in binding and neutralizing antibodies over the period, though the average levels for both antibody types remained above the median of a panel of 41 recovered COVID-19 patients. Story

Pfizer is expected to provide enough initial shot doses for 3.2 million Americans if it wins clearance from the FDA — not nearly enough for the country’s 21 million healthcare workers, Reuters reports. Complicating matters further, those first doses are slated for delivery to five government agencies, officials have said. After that, vaccine distribution could cover 7 million to 10 million people per week, assuming Moderna’s shot gets a thumbs up in the second half of December and Pfizer meets its estimates for followup deliveries, the news outlet predicts.

With the pandemic ushering in an industrywide pivot to digital, Omnicom Group’s Tribal Worldwide is spinning out a new pharma specialty unit, Tribal Health, to help clients grapple with virtual realities of the modern age. Current Tribal clients GlaxoSmithKline and Gilead are among those moving to the new unit’s roster. Meanwhile, boots-on-the-ground sales reps won’t disappear completely — they’ll just become more digitally-focused, Jason Galla-Barth, a managing partner at Tribal who will lead Tribal Health, said. Story

Sales of Everlywell’s at-home diagnostics, including a kit for COVID-19, are expected to quadruple this year. Investors have taken note, helping the company raise $175 million in its second venture capital funding round this year. Everlywell will use the cash to boost telehealth offerings, focusing on routine diagnostic tests to help manage chronic disease and track care in clinical trials. The company in February bagged an FDA emergency nod for its swab-based home collection kit, which users can ship to labs overnight for analysis with a range of tests. Story

Meanwhile, at-home saliva tests could offer a salve to the high demand and slow turnaround for swab-based diagnostics, The New York Times reports. Recently, more communities across the U.S. have started rolling out do-it-yourself spit tests. In Minnesota, for instance, at-home testing kits are typically shipped within 24 hours after an order is placed. Users are guided through the sample collection process with a healthcare worker over Zoom, and once samples are shipped to a lab, results are delivered in one to two days.

The White House could realistically achieve its goal of vaccinating 20 million Americans before year-end, FDA Commissioner Stephen Hahn told Reuters. Earlier this week, Hahn met with chief of staff Mark Meadows in what he called a “robust” discussion about vaccine approval timelines. To hit the Trump Administration’s vaccination goal, the FDA would need to clear both Pfizer and Moderna’s shots — slated for review on Dec. 10 and Dec. 17, respectively — within the month.

Meanwhile, Stephen Hahn took to Twitter Friday to help demystify the regulator’s vaccine application review process.

#Vaccines101: FDA evaluation of a vaccine application includes assessing the data and the product, its quality and safety, and the technology to manufacture it. #FDAVaccineFacts https://t.co/uxcPWmhbrM
— Dr. Stephen M. Hahn (@SteveFDA) December 4, 2020

Lexaria Bioscence published preclinical data showing its DehydraTECH platform — designed to improve oral delivery of antiviral drugs — could successfully deliver HIV meds from Johnson & Johnson and Bristol Myers Squibb in rats. Using the study as a launchpad, Lexaria in January plans to start testing the technology on antivirals used to treat HIV and COVID-19. Story

UPDATED: Friday, Dec. 4 at 9:19 a.m. ET

Once a COVID-19 shot snares approval, the next challenges will be rapid-fire production and equitable distribution across the U.S., top executives from Johnson & Johnson, Moderna and Pfizer told NBC. Access to vaccines in Black and Hispanic communities, which have been hit especially hard by COVID-19, is one major concern, J&J chief Alex Gorsky said. Meanwhile, Pfizer CEO Albert Bourla, M.D., said his company is working with regulators to find a way to vaccinate trial participants who received placebo, calling the move an “ethical dilemma and obligation.” Story

NIAID Director Anthony Fauci, M.D., will keep his post under President-elect Joe Biden and will also serve as chief medical adviser to the White House, The New York Times reports. Biden also asked the nation’s top infectious disease expert to join his COVID-19 team — an offer Fauci said he accepted “right on the spot.” Fauci has been sidelined by President Donald Trump in recent months as the two allegedly sparred over use of masks, the pandemic’s trajectory and more.

Pfizer set the record straight on a Thursday report from The Wall Street Journal stating raw material shortages would cut the drugmaker’s 2020 vaccine output from 100 million doses to 50 million doses. The information is correct, but outdated, a company spokesperson told Barron’s. Pfizer on Nov. 9 announced it would scale back its 2020 production target, weeks before WSJ’s report, and has used the updated figures in its public forecasts since. Story

Clover Biopharmaceuticals’ protein-based S-Trimer vaccine candidates, in combination with adjuvants from either GlaxoSmithKline or Dynavax, triggered a safe and effective immune response in a 150-subject phase 1 study, the company said. Testing showed the vaccines were stable for six months at fridge temps of between 2 and 8 degrees Celsius (35.6 and 46.4 degrees Fahrenheit) and could last up to a month at room temperature, potentially easing future distribution. A phase 2/3 trial with GSK’s adjuvant is slated to kick off in December, with a separate Dynavax adjuvant trial to follow in 2021. Story

Rich countries have cornered global supply of COVID-19 vaccines, suggesting low-risk people in nations like the U.S. will likely be immunized before high-risk people in poorer countries, NPR reports. The U.S. leads the pack with 2.6 billion potential doses locked down, followed by the EU with 2 billion prospective shots and India at 1.6 billion. Meanwhile, when shots become widely available next year, the U.S. will likely have enough doses to vaccinate its entire population twice over.

A blood test could help predict efficacy of coronavirus vaccines and pave the way for easier study of next-generation shots, a monkey trial published in Nature found. The study found telltale blood markers that predict whether a monkey’s immune system is equipped to fight off the virus, raising hopes that researchers could look for those same markers in human vaccine trials.

UPDATED: Thursday, Dec. 3 at 3:24 p.m. ET

The pandemic has at times created huge surges in demand for medical supplies such as personal protective equipment and testing supplies. Now, with vaccines nearing potential rollouts, dry ice is becoming a crucial commodity to help keep the shipments cold, The Wall Street Journal reports. Companies involved in making dry ice expect to have a busy December, the newspaper reports.

With billions of vaccinations expected in the coming years, Becton Dickinson is gearing up to meet demand for prefilled syringes. The company is spending $1.2 billion on a new production site in Europe and investing in other existing facilities. Story

Inovio, aiming to boost potential capacity for its INO-4800 vaccine, inked a production deal with Kaneka Eurogentec. Specific details weren’t disclosed. Inovio’s program is in phase 2 testing, and while the company released interim phase 1 results, it has not released a full phase 1 readout. Release

UPDATED: Thursday, Dec. 3 at 9:35 a.m. ET

Results from AstraZeneca’s late-stage U.S. vaccine trial will likely roll in by late January, Operation Warp Speed chief Moncef Slaoui, M.D., said. That’s important, because the large set of contrasting data from trials in the U.K. and Brazil may not be enough to convince the FDA to grant the British drugmaker an emergency nod, Slaoui said. AZ recently reported that its vaccine was 90% effective when given as a half-dose primer followed by a full-dose booster, while the intended two-dose regimen charted efficacy around 70%.

An editorial in The New England Journal of Medicine is challenging a large, WHO-run trial that found Gilead’s antiviral Veklury, also known as remdesivir, did little to improve COVID-19 survival. Among the issues raised? WHO’s trial took place across 30 countries, fueling inconsistencies in the data collected. Plus, the study researchers did not collect or record standard of care or healthcare capacity in any of the 400 hospitals tapped for the trial.

Former U.S. Presidents Barack Obama, George W. Bush and Bill Clinton all volunteered to roll up their sleeves for a COVID-19 vaccine — and they’re willing to do it on camera to help persuade the public the shot is safe, CNN reports. Obama said he would feel confident in a vaccine endorsed by NIAID Director Anthony Fauci, though he acknowledged that some Black Americans might be more hesitant to get the shot because of historical racism in the healthcare system.

Meanwhile, Fauci, the U.S.’ top infectious disease expert, slammed the U.K. for its speedy authorization of Pfizer and BioNTech’s vaccine. “If you go quickly and you do it superficially, people are not going to want to get vaccinated,” Fauci told Fox News. The U.K. did not review its shot as carefully as the FDA plans to do, he said. “They got a couple of days ahead. I don’t think that makes much difference.”

England’s National Health Service and Medicines and Healthcare products Regulatory Agency are scrambling to figure out how to deploy Pfizer’s vaccine, which must be stored at a frigid minus 94 degrees Fahrenheit, in care homes, Reuters reports, citing deputy Chief Medical Officer Jonathan Van-Tam. There;s “no absolute assurance” the U.K. can get the shot to those residents, Van-Tam said, arguing, “one thing we can’t do is … end up with a vaccine that’s been handled incorrectly, and then isn’t properly viable at the end of the distribution chain.”

Pfizer is committed to working with the Indian government to make its vaccine available in-country, the Hindustan Times reports, citing a company spokesperson. Back in November, V K Paul, who heads the country’s COVID-19 task force, warned it might take months for Pfizer’s shot to arrive in India, with cold chain arrangements the biggest hurdle the nation needs to overcome.

Sanofi and GlaxoSmithKline plan to announce the price of their COVID-19 vaccine candidate upon the release of phase 1/2 trial results, expected before the end of the month, Thomas Triomphe, vaccines chief at Sanofi, said Thursday.

South Korea on Friday inked a deal to import doses of AstraZeneca and the University of Oxford’s vaccine hopeful, public health authorities said. The government will hammer out the specific dose count and delivery timeline at a later date. Meanwhile, South Korea has also signed a memorandum of understanding with Johnson & Johnson and Pfizer.

IBM says it has uncovered a “global phishing campaign” targeting organizations focused on the COVID-19 vaccine cold chain. The report was reposted by The U.S. Cybersecurity and Infrastructure Security Agency in a warning to members of Operation Warp Speed. Bogus emails were sent to roughly 10 different organizations, with the European Commission’s Directorate-General for Taxation and Customs Union the only group IBM cited by name.

Meanwhile, North Korean hackers are targeting vaccine makers Johnson & Johnson and Novavax, as well as South Korean drugmakers Genexine, Shin Poong Pharmaceutical and Celltrion — all running earlier-stage trials of COVID meds, The Wall Street Journal reports, citing sources close to the matter. Meanwhile, Reuters reported Friday that North Korean hackers had attempted to breach AstraZeneca’s systems, too. It’s unclear whether the hackers purloined any information.

UPDATED: Wednesday, Dec. 2 at 3:17 p.m. ET

A quintet of top vaccine makers are set to split around $38.5 billion in sales next year — and Pfizer, freshly armed with a U.K. approval, is in line for a $14.3 billion slice of the pie, Bernstein analysts figure. Moderna should expect to reap $10.9 billion, followed by $6.4 billion for AstraZeneca, $3.9 billion for Novavax and $3 billion for Johnson & Johnson. The analysts further predicted $23.1 billion in total vaccine sales in 2022, $12.6 billion in 2023 and $8.5 billion in 2024 before the market settles at around $6 billion in 2025. Story

Merck & Co. on Tuesday said it had divested its stake in Moderna, fueling “a small fourth-quarter gain.” It’s unclear how much Merck stands to make, but it’s likely to be significant: Moderna went public in December 2018 at a price of $23 per share, while Tuesday’s closing price was $142. Merck first pumped $100 million in cash and stock into Moderna in 2015 to partner on five preclinical mRNA projects, later investing another $125 million in 2018. Story

The Trump Administration aims to vaccinate 100 million people by February — enough to cover all healthcare workers and the country’s at-risk population, Operation Warp Speed (OWS) officials said Wednesday. Twenty million people are expected to get a shot by year-end, followed by 30 million people in January and another 50 million by February, Warp Speed chief Moncef Slaoui said. Story

Roche got a thumbs up from the FDA for its Elecsys quantitative antibody test, a more accurate blood test able to measure the levels of specific antibodies that target the coronavirus’s spike protein. The test could help weigh the efficacy of vaccines and ID recovered patients with potential to serve as convalescent plasma donors, the company said. Running on Roche’s cobas e analyzers, the test provides a result in about 18 minutes. Story

Nova Scotia, Canada-based drugmaker Appili Therapeutics on Wednesday said investigators had dosed the first patient in a phase 3 trial assessing Fujifilm’s flu med Avigan, also known as favipiravir, in COVID-19. One of three Appili-run Avigan trials, the so-called Preseco study will test whether the drug can alleviate symptoms and prevent disease progression in patients with mild to moderate COVID-19. The study will look to enroll 826 subjects, with early results expected in the first half of 2021, Appili said.

Move over hackers: Organized criminal networks could be the latest group to target COVID-19 vaccines, and they may even look to sell counterfeit shots, the international police organization Interpol warned Wednesday. “[Criminal organizations] are planning to infiltrate or disrupt supply chains,” Interpol’s secretary general said in a warning to the agency’s 194 member countries. “Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures.”

The European Union is none too pleased with the U.K.’s rapid fire authorization of Pfizer and BioNTech’s vaccine, Reuters reports. Through an emergency approval process, the U.K.’s drug regulator was able to temporarily OK the shot only 10 days after starting its review of data from large-scale trials. The European Medicines Agency argued its longer approval process is better suited to the task, because it calls for more data and involves more checks than the U.K.’s emergency procedure.

On orders from President Vladimir Putin, Russia will kick off a voluntary mass vaccination campaign next week, with teachers and doctors likely among the first to receive the shot. The country will have produced 2 million vaccine doses within the next several days, Putin added. Russia has already vaccinated more than 100,000 high-risk people with its Sputnik V vaccine, the country’s health minister said during a United Nations presentation on the shot.

UPDATED: Wednesday, Dec. 2 at 9:03 a.m. ET

The U.K.’s Medicines & Healthcare Products Regulatory Agency Wednesday doled out an emergency use authorization for Pfizer and BioNTech’s vaccine. The U.K. has a contract for 40 million doses. Shipments are expected to start rolling in immediately, and shots will be made available across the country starting next week. Meanwhile, Pfizer’s shot is due for a Dec. 10 advisory committee review in the U.S. Story

The European Medicines Agency (EMA) on Tuesday kicked off a rolling review of Johnson & Johnson’s recombinant vector vaccine candidate. The hastened process will allow Europe’s health regulator to assess J&J’s shot in real time as data trickles in. The EMA previously initiated rolling reviews on shots from AstraZeneca, Moderna, and Pfizer and BioNTech.

Serum Institute of India will continue testing a full two-dose regimen of AstraZeneca’s vaccine — despite a recent data reveal showing an initial half-dose primer might spark greater efficacy. At two full doses, AstraZeneca’s shot proved 62% effective in phase 3, well below the figures presented by Pfizer and Moderna. That said, “Anything which is beyond 50% is always going to be a plus,” Suresh Jadhav, an executive director at SII, told Reuters. He added that changing dosing now would also delay trials.

The CDC’s Advisory Committee for Immunization Practices (ACIP) voted 13–1 Tuesday to recommend healthcare workers and long-term care residents get first dibs on an authorized COVID-19 vaccine. ACIP also recommended vaccinating nursing home staffers alongside residents. The committee is due to meet again after a Dec. 10 advisory committee review of Pfizer’s shot hopeful, where it will vote to recommend whether an authorized shot should go out to the public.

While the leading slate of vaccines have been well-tested in adults, there’s a dearth of information on how those shots might work in younger children. Now, pediatricians are urging drugmakers to step up their game. The American Academy of Pediatrics, for instance, has called on researchers to expand clinical trials to include children of all ages as soon as possible. Others argue that a vaccine that works in children is a critical step to reopening classrooms. Pfizer, for its part, started including children ages 12 and older in its trial this fall.

President Donald Trump has summoned vaccine manufacturers, drug distributors and government officials for a White House COVID-19 summit on Dec. 8, just days before planned reviews of Pfizer and Moderna’s vaccine candidates. Industry officials aware of the plan painted the move as an opportunity for the White House to pressure the FDA to quickly issue emergency approvals for the shots. Pfizer and Moderna, plus companies like McKesson, Walgreens, CVS Health, Fedex and more are reportedly among those invited.

UPDATED: Tuesday, Dec. 1 at 3:19 p.m. ET

Regeneron tapped gene therapy pioneer Jim Wilson and the University of Pennsylvania to help deliver its antibody cocktail as a prophylactic nasal spray. The biotech’s recently-authorized therapy is injected, but Regeneron and Penn aim to leverage Wilson’s gene therapy expertise to attempt an intranasal formulation using adeno-associated virus (AAV) vectors. By introducing the therapy via single dose of AAV, Wilson’s team thinks the drug could provide protection on par with Regeneron’s cocktail, but “for potentially a longer duration.” Story

Amgen, Takeda and UCB kicked off an adaptive trial to see whether any one of a trio of drugs could curb the unchecked inflammatory response seen in some COVID patients. The trial will assess Amgen’s psoriasis and psoriatic arthritis med Otezla; Takeda’s IV formula of its hereditary angioedema therapy Takhzyro; and UCB’s experimental autoimmune drug zilucoplan. The study will recruit a range of hospitalized patients, from those with mild disease to patients requiring ventilation or oxygen support. Story

Scott Atlas, pandemic adviser to President Donald Trump, resigned Monday. A neuroradiologist without an infectious disease or public health background, Atlas drew fire for suggesting the virus should be allowed to spread among young, healthy people to help the U.S. hit “herd immunity.” Atlas allegedly sparred with fellow task force members Deborah Birx and Anthony Fauci over boosting testing efforts, too, and forwarded fringe theories about the ineffectiveness of masks and social distancing.

Only 10% to 15% of subjects in Pfizer and Moderna’s late-stage vaccine trials reported “significantly noticeable” side effects, Moncef Slaoui, head of the Trump administration’s Operation Warp Speed program, said. Participants hit with side effects reported pain at the injection site, fever, chills, muscle aches and headaches, with most reactions lasting up to a day and a half. While the short- and “mid-term” effects of the vaccines are now well known, longer-term safety “is not yet understood by definition,” Slaoui cautioned.

The European Medicines Agency (EMA) said Tuesday that it plans to meet by Dec. 29 to weigh Pfizer and BioNTech’s vaccine hopeful for a possible emergency approval, with a review for Moderna’s mRNA-based candidate pegged for Jan. 12. Pfizer, which earlier Tuesday asked the European Union’s drug regulator for a speedy review, now has a slimmer chance of rolling out its shot in the bloc before year-end, though the EMA said it could bump up the meeting date if data comes in quickly.

Meanwhile, Germany aims to start vaccinating vulnerable people and caregivers by January, health minister Jens Spahn told the German broadcaster Deutschlandfunk. The country is setting up special vaccination centers, pegged to come online in mid-December, to grapple with the cold storage requirements for Pfizer and BioNTech’s shot, which must be kept at a frigid minus 94 degrees Fahrenheit. Spahn last month said he expected Germany to receive upward of 100 million doses of Pfizer and BioNTech’s vaccine.

SAB Biotherapeutics bagged $57.5 million from the Biomedical Advanced Research and Development Authority and the Department of Defense to help manufacture its experimental polyclonal antibody, SAB-185. The antibody was developed using SAB’s DiversitAb Rapid Response Antibody Program and is currently in a phase 1 trial in healthy volunteers and a phase 1b study in patients with mild to moderate COVID-19.

As the push to vaccinate looms, dentists and optometrists are seeking clearance to administer COVID shots during routine eye exams and teeth cleanings, NBC News reports. Professional organizations representing dentists and optometrists in California are in talks with state officials to expand their roles to include vaccination, while Oregon has already started training and certifying dentists to dole out shots. Meanwhile, at least half of U.S. states have considered deputizing dentists as vaccinators, according to the American Association of Dental Boards.

UPDATED: Tuesday, Dec. 1 at 8:45 a.m. ET

Having already filed their mRNA-based vaccine for emergency use in the U.S. and the U.K., Pfizer and BioNTech have now submitted the shot at the European Medicines Agency. The partners filed for the FDA’s approval late last month after unveiling interim late-stage data showing their shot hit a 90% efficacy mark; a recent update boosted that number to 95%.

As the FDA reviews Pfizer’s shot, the agency has also set a date to consider another mRNA-based coronavirus vaccine from Moderna that posted even more impressive first-round data. The FDA’s Vaccines and Related Biological Products Advisory Committee will pore over Moderna’s late-stage stats on Dec. 17, the agency said in a release, setting the stage for an emergency use authorization to follow.

Looking for a win in the waning days of Donald J. Trump’s presidency, White House Chief of Staff Mark Meadows called FDA Commissioner Dr. Stephen Hahn into an early morning meeting Tuesday to quiz him about why Pfizer’s vaccine hasn’t scored an EUA already, Axios reported. In a statement to the news outlet before that meeting, Hahn said agency scientists would “take the time that’s needed” for a review, potentially putting him on a bad footing with the White House. The shot is scheduled for an FDA advisory panel review Dec. 10. Story

The NIH’s National Institute of Allergy and Infectious Diseases kicked off the fourth iteration of its catchall COVID-19 trial, investigating leading treatments for moderate-to-severe COVID-19. Patients in one arm of the study will receive a combo of generic steroid dexamethasone and Gilead Sciences’ remdesivir, marketed as Veklury in the U.S. Meanwhile, a second arm will receive remdesivir and Eli Lilly’s Olumiant (baricitinib).

Amid rising domestic case counts and deaths, Russia is seeking to import a swath of foreign drugs to help fight a surge in COVID-19, Reuters reported. The nation has worked to develop its own treatments for the virus, with names like Coronavir and Avifavir, but has run into chronic shortages in some regions.

A new study from the Centers for Disease Control and Prevention found that the earliest cases of COVID-19 were likely on the West Coast as early as December 2019, potentially weeks before global health regulators became aware of a growing outbreak in Wuhan, China, the Wall Street Journal reported.

More research from the University of Oxford suggests the risk of long-term lung damage in COVID-19 patients — defined as aftereffects that last more than three months — is higher than previously known.

UPDATED: Monday, Nov. 30 at 3:11 p.m. ET

Novavax is facing “additional questions” from the FDA over its decision to tap Fujifilm Diosynth’s North Carolina plant for commercial-scale manufacturing of its vaccine for a phase 3 North American trial, pushing the study start date into late December at the earliest. The FDA’s line of questioning remains unclear and a Novavax spokeswoman couldn’t clarify the regulator’s inquiries over email. While Novavax’s U.S. trial is delayed, the biotech has finished enrollment for a 15,000-person U.K. phase 3 and is wrapping up a phase 2b study in South Africa, the company said. Story

Pfizer has been running “dry rehearsals” of its shot deployment scheme at more than 50 U.S. distribution sites, Operation Warp Speed’s Gen. Gustave Perna said last week. Pfizer has also created YouTube videos for staffers to consult as they receive, store and dispatch the vaccine. “As Pfizer has walked the administration sites through the execution, we see growing confidence in everybody,” Perna said, adding that he’d personally gone through the process, which he described as “very, very doable.” Story

Meanwhile, Pfizer’s shot could snare approval “within days” of its Dec. 10 advisory panel review, Department of Health and Human Services secretary Alex Azar said Monday. “Moderna is basically one week behind that,” he added. After that, it will be up to governors to decide who receives the first slate of shots. The CDC’s Advisory Committee on Immunization Practices is continuing talks on how to divvy up vaccines, Azar said, and he expects more information on those priorities this week.

Kantaro Biosciences, a joint venture between Mount Sinai Health System and RenalytixAI, won an emergency nod for its COVID-19 antibody diagnostic, COVID-SeroKlir. The diagnostic provides a semi-quantitative blood test that measures the amounts of IgG antibodies — specifically those that target the virus’s spike protein and its receptor-binding domain, potentially slowing the course of an infection. The diagnostic won a CE mark in Europe in late October and Kantaro aims to crank out up to 10 million tests per month through a commercial partnership with Bio-Techne. Story

Northwestern University researchers say they’ve developed an AI algorithm to automatically detect signs of COVID-19 on a basic X-ray of the lungs. The AI could be used to rapidly screen patients upon entry into the hospital, especially for reasons unrelated to coronavirus symptoms, triggering protocols to help protect healthcare workers. Story

The FDA delayed a decision on Revance’s frown-line injection daxibotulinumtoxinA thanks to COVID-19 restrictions that kept agency inspectors from assessing the company’s Newark, California manufacturing facility on time. The delay didn’t turn up any immediate manufacturing or data issues, and Revance’s drug could still snare approval in the first half of 2021, Mizuho analysts wrote. Story

The European Medicines Agency’s safety committee, PRAC, has called for a labeling update on all products containing chloroquine and hydroxychloroquine about the risk of suicidal behavior and psychiatric disorders. Neither drug is approved to treat COVID-19, but both have been used off label in the disease despite underwhelming readouts in large clinical trials.

Scientists and COVID trial participants are combatting vaccine misinformation on TikTok. One user, Dr. Noc, hard at work developing an antibody treatment for COVID-19 when not posting on the video sharing platform, has been uploading science-based videos since February. Meanwhile, Ashley Locke, who posted about her experience in AstraZeneca’s vaccine trial, has racked up more than 2 million views on her post. Since then, she’s made videos and answered questions from her comments section about side effects, use of masks post-trial and more.

UPDATED: Monday, Nov. 30 at 9:56 a.m. ET

Moderna said it will apply on Monday for an emergency use authorization from the U.S. FDA and for conditional marketing authorization from the EMA, with rolling review underway in other territories. The company slightly adjusted its mRNA-1273’s efficacy stat to 94.1% from the previous 94.5% now that it has accrued 196 infected cases from a phase 3 trial. Still, no severe COVID-19 cases have cropped up in the vaccine arm, while the placebo group had 30. Story

AstraZeneca isn’t so lucky with its University of Oxford-partnered AZD1222. The company now expects to run another phase 3 trial as scientists raised doubts about its existing data. The company previously revealed that the experimental shot was 90% effective in a subgroup of phase 3 trial participants who got a half-dose of the vaccine by mistake, while the correct dosing only demonstrated efficacy of about 60%. “Now that we’ve found what looks like a better efficacy, we have to validate this, so we need to do an additional study,” CEO Pascal Soriot told Bloomberg. Story

Meanwhile, the AZ shot is facing an adverse reaction allegation in India, where its partner Serum Institute of India is running a trial. A 40-year-old man claims he suffered serious “neurological and psychological” symptoms after receiving the vaccine, according to Reuters. The trial volunteer is seeking 50 million rupees ($676,288) in compensation and suspension of activities around the vaccine. The Indian Council of Medical Research is looking into the matter but has so far recommended that the trial proceed.

Another vaccine that has reported phase 3 data, Pfizer and BioNTech’s BNT162b2, has already started commercial deliveries from its manufacturing site. A first batch of the vaccine reportedly arrived at Chicago’s O’Hare International Airport in a chartered flight from Brussels in what the Federal Aviation Administration described as the first “mass air shipment” of a COVID shot. The Pfizer vaccine is expected to be authorized for emergency use by mid-December. Until then, no vaccine can be shipped to administration sites. Story

With BNT162b2, the U.K. is poised to become the first Western country to approve a COVID-19 vaccine. Domestic health regulators are on track to greenlight the Pfizer-BioNTech shot within days, and deliveries will begin within hours of authorization, the Financial Times reported, citing government officials.

The U.K. has appointed Nadhim Zahawi, a member of the U.K. parliament, as a new minister to oversee the rollout of COVID vaccines in England. Britain has gained access to 357 million doses of vaccines from seven developers, including an additional 2 million doses of Moderna’s mRNA-1273 that it just secured on top of the original 5 million agreed. It has also placed orders for 100 million doses of the AZ-Oxford vaccine and 40 million doses of Pfizer-BioNTech’s.

Also in the U.K., efforts remain ongoing in the search for effective COVID therapeutics under the Recovery master trial. Colchicine, a drug used to treat gout and Behçet’s disease, has been included in the trial. Investigators expect to enroll at least 2,500 patients to the colchicine arm to evaluate its ability to reduce dangerous immune overreactions in hospitalized patients, including its impact on death rate, hospital stay and need for ventilator support.

In the U.S., antibody therapies by Regeneron and Eli Lilly have already won emergency nods for outpatients, and the Trump administration has secured 300,000 doses from each company. But experts raised concerns that it would be difficult for medical centers to keep their infusion sites separate from those used by patients not infected with Sars-CoV-2.

As research around COVID presses on, accusations of attempts to steal those discoveries have pointed at Russia, China and Iran. Now, North Korean hackers have been fingered in a seemingly failed attempt to infiltrate AstraZeneca and its vaccine work. The hackers posed as recruiters and approached AZ staffers with fake job offers, and then sent malicious emails designed to gain illegal access to company computers, two people with knowledge of the matter told Reuters. Story

COVID has obviously attracted a lot of research resources during the pandemic, causing delays to clinical trials in other areas. The lockdowns also restricted scientists from accessing crucial research facilities and equipment. A survey of scientists at The Institute of Cancer Research in London found that oncology experts on average expect an average six-month delay to their scientific advances.

Indian generics player Hetero penned a deal to produce more than 100 million doses per year of Russia’s COVID vaccine Sputnik V in India starting from 2021, the Russian Direct Investment Fund, Russia’s sovereign wealth fund and backer of the shot, said Friday. The adenovirus-vectored vaccine recently touted a 91.4% efficacy at an interim analysis involving nearly 19,000 volunteers.

UPDATED: Wednesday, Nov. 25 at 9:30 a.m. ET

Pfizer and BioNTech’s vaccine candidate could roll out shortly after Dec. 10, Alex Azar said. “We believe we can distribute vaccine to all 64 jurisdictions within 24 hours of FDA authorization,” he said, adding that the hope is to kick start vaccinations as soon as shipments arrive. By mid-December, 6.4 million Pfizer doses are expected to go out to states and territories, out of a total 40 million doses slated for delivery this year, General Gustave Perna, who oversees Operation Warp Speed, said. Warp Speed will also run test shipments this week to prepare for its distribution push.

COVAX, the World Health Organization’s equitable vaccine distribution scheme, has secured hundreds of millions of AstraZeneca doses, said Gavi, the Vaccine Alliance — co-leader of the initiative. Gavi hailed AZ’s recent data reveal as “positive news for the COVAX vision of equitable access.” Even more promising, AZ’s shot can be shipped and delivered using traditional refrigeration and storage methods, and the company has pledged to supply shots at no profit while the pandemic persists, Seth Berkley, CEO at Gavi, said.

BioNTech and Shanghai Fosun plan to launch a phase 2 trial of the German biotech’s vaccine hopeful, BNT162b2, in China, the companies said Wednesday. Testing is slated to take place at Jiangsu Provincial Center for Disease Control and Prevention and will assess safety, plus the shot’s ability to provoke an immune response.

Sinopharm filed a request with the National Medical Products Administration to start marketing at least one of its COVID-19 vaccine candidates in China, Xinhua Finance News reports, citing deputy general manager Shi Shengyi. The report did not specify which — or how many — of the drugmaker’s two inactivated candidates, both still in late-stage testing, were up for approval. Meanwhile, an anonymous Sinopharm exec told South China Morning Post the Xinhua report was “inaccurate” and the company had yet to file for a marketing nod.

States are on the hook to prioritize who gets the first coronavirus vaccine doses, HHS Secretary Alex Azar said. While a CDC advisory committee plans to meet immediately after an approval to hash out early access, governors will have “final say,” which could lead to widely differing distribution schemes across the nation. The CDC’s panel, the Advisory Committee on Immunization Practices, on Monday said distribution should aim to tackle health inequities and disproportionate infections, deaths and hospitalizations among Black, Latino and Native American populations.

The European Union wants to accelerate the process for issuing compulsory licenses, which could allow the bloc to bypass intellectual property rights on generic drugs to shore up supply during the pandemic, Reuters reports. The move would serve as a “last resort” and “safety net,” an EU document said, essentially giving EU states the ability to manufacture generic meds without drugmakers’ consent. Compulsory licensing is allowed by the World Trade Organization as a means to waive normal regulations during an emergency.

Plus, the European Medicines Agency (EMA) thinks it could issue a “positive opinion” on a vaccine before Christmas, Emer Cooke, executive director of the agency, told the Irish news outlet RTE. Cooke on Tuesday said the EMA aims to make an authorization decision around the same time as the U.S. FDA, which plans to review Pfizer’s shot in mid-December.

Public health officials and drugmakers should be transparent about unpleasant vaccine side effects to ensure people return for a second dose, doctors said during a meeting with CDC advisors. High fever, body aches, headaches, exhaustion and other symptoms were reported by participants in Moderna and Pfizer’s vaccine trials in September. While unpleasant, symptoms usually passed after about a day, participants said. Those side effects are “no walk in the park,” but messaging must be clear so that patients aren’t deterred from getting a second dose, doctors said.

UPDATED: Tuesday, Nov. 24 at 3:08 p.m. ET

AstraZeneca’s late-stage vaccine proved 90% effective in a small group of subjects that received a half-dose primer followed by a full-dose booster — but that was never the plan. “It was a mistake,” Mene Pangalos, EVP at the company, told Reuters. The error became apparent when some participants had milder-than-expected side effects, which led researchers to realize they’d “underpredicted the dose of the vaccine by half,” he said. It’s unclear how effective the primer-dose regimen truly is. Only 2,741 subjects received the half dose in a more than 30,000-person phase 3. Story

Among more than 74% of Americans who’ve heard about Pfizer’s promising vaccine data, 48% now report a more positive view of the company, The Harris Poll found. Meanwhile, 41% of respondents said they’ve developed a more favorable view of drugmakers involved in the pandemic vaccine race, while 40% report a sunnier outlook on the industry as a whole. Forty-six percent of people polled also had a more favorable view of the vaccine development process, while 39% adopted a more positive outlook on the approval process. Story

GE Healthcare launched an AI algorithm that can read X-rays to pin down proper placement of ventilator tubes in patients under critical care. As many as one in four patients intubated outside of an emergency room may have a misplaced endotracheal tube, the company estimates, which can lead to severe complications like over-inflating or collapsing of a lung. The algorithm, included in GE’s Critical Care Suite, works on the mobile X-ray scanner itself and automatically detects the tube in chest X-ray images, helping flag potential dangers. Story

Two single-domain antibodies, or nanobodies, developed by Twist Bioscience protected coronavirus-infected hamsters from weight loss — a key indicator of disease severity, the biotech said. The weight-loss protection was comparable to results with convalescent plasma in previous clinical studies. Armed with positive hamster data, Twist is now weighing its options, including potentially licensing out the assets for further development, a company spokesperson said. The candidates could be used to develop a preventive daily nasal spray, Twist added. Story

More than 175 U.S. patients with critical COVID-19 respiratory failure and a severe comorbidity have entered into an expanded access protocol (EAP) with NeuroRx and Relief’s RLF-100, also known as aviptadil. Of the 90 patients who’ve so far reached 28 days followup, 72% survived to day 28, the companies said. In a previous comparison between 21 patients given RLF-100 and 24 on standard of care, only 17% of those in the control group survived to day 28, while survival rate with RLF-100 was similar to the 72% figure reported Tuesday, the companies said.

Thirteen African nations are teaming up on a clinical trial to test whether drugs for malaria, HIV, certain cancers and other diseases could prevent moderate COVID-19 cases from becoming more severe, The New York Times reports. The trial will be carried out by ANTICOV, a consortium of 26 African and European clinical institutions. Testing has already kicked off in the Democratic Republic of Congo, with Kenya close behind. Meanwhile, the Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan and Uganda are waiting on regulatory approval to pitch in.

Reckitt Benckiser’s latest campaign for its over-the-counter cold and flu brand Mucinex encourages patients to “be an ally” to doctors by saying thanks and posting an online review. That support is more important than ever during the pandemic, Claudine Patel, general manager of marketing for RB’s North America Consumer Health unit, said. The company has partnered with Healthgrades.com to set up a dedicated page slated to roll out digital ads and social efforts from physician influencers. RB’s thinking is backed by data, too: A recent Mucinex and Harris Poll found that 80% of Americans who left online doctor reviews did so to report a positive experience. Story

UPDATED: Tuesday, Nov. 24 at 9:30 a.m. ET

The European Union on Wednesday is expected to approve a deal securing up to 160 million doses of Moderna’s vaccine candidate, Ursula von der Leyen, head of the European Commission, said. The bloc in August said it had wrapped preliminary talks with Moderna to lock down 80 million initial doses and an option to purchase 80 million more. Moderna last week revealed its shot was 94.5% effective in phase 3. Story

Plus, Moderna tapped Swedish drugmaker Recipharm to carry out fill and seal packaging on its mRNA-based vaccine candidate. Work will take place at Recipharm’s manufacturing unit in Monts, in central France.

Thanks to a rolling EU review, AstraZeneca thinks it could see a “relatively fast approval” for its shot candidate in Europe, Iskra Reic, EVP of the company’s Canadian and European operations, told Euronews. Should the vaccine pass the European Medicines Agency’s bar, Reic said she was “absolutely convinced” AZ could deploy the shot to all EU member states in roughly the same timeframe. She added the company was still parsing the biology behind Monday’s puzzling data reveal and cautioned against the unreliability of cross-trial comparisons.

Médecins Sans Frontières (MSF) called on AstraZeneca to re-commit to its no-profit vaccine pledge and urged the drugmaker to open the books on its licensing and purchase deals so that people and governments could demand a fair price. AZ has said it won’t profit off its shot during the pandemic, but terms of a deal disclosed by the Financial Times show the drugmaker can declare the pandemic over as early as next July — well before MSF thinks COVID-19 will be under control. That could open the floodgates for steep shot pricing in 2021’s second half, MSF warned.

Meanwhile, Italy is set to receive 16 million AstraZeneca doses in early 2021 through the European Union’s supply deal, a government source told Reuters. The country will receive an initial 4 million doses in January, followed by another 12 million between February and April, the source said. Plus, Italy is also in line to receive 3.4 million doses of Pfizer and BioNTech’s shot as early as January.

Brazil has collected enough infection data from a phase 3 trial of Sinovac’s shot hopeful to potentially unveil interim data in early December, Reuters reports, citing trial organizers from the country’s Butantan Institute. The study now has 74 confirmed cases, passing the threshold of 61 infections needed for an interim analysis, Dimas Corvas, the institute’s director, said. Brazilian health officials have pegged a possible approval of Sinovac’s shot for December or January.

The Nanovaccine Institute at Iowa State University is teaming up with drug delivery device specialist Zeteo Biomedical to develope a next-generation nasal spray vaccine for COVID-19. The single-dose prophylactic, designed for stability at room temperature, could potentially be self-administered using Zeteo’s intranasal delivery device. Meanwhile, the university in late October scored $2 million from the Coronavirus Aid, Relief and Economic Security Act to support its development efforts. Story

Russia’s Sputnik V vaccine proved 91.4% effective in a second interim analysis from the country’s 40,000-person phase 3. The second analysis was carried out after 39 cases were confirmed in the trial — 31 in the placebo arm and 8 in the group who received the vaccine. No unexpected health scares were observed, with typical side effects including injection site soreness, fever, fatigue, weakness and headache. Russia plans to unveil further data once 78 infections have been confirmed. Story

And Russia plans to sell Sputnik V for less than $10 per dose internationally and make it free for its own citizens, the Russian Direct Investment Fund said. The country’s current deals with foreign drugmakers provide capacity for enough doses for 500 million people per year, starting in 2021, though Russia says it’s on the hunt for additional deals to boost supply. Meanwhile, Russia expects to send the first doses out to customers in January.

UPDATED: Monday, Nov. 23 at 3:35 p.m. ET

Moderna will submit its shot for emergency authorization by month’s end, with a review slated to take place on Dec. 17, Operation Warp Speed chief Moncef Slaoui told ABC News. Meanwhile, an FDA advisory committee is set to review Pfizer’s vaccine data Dec. 10, he said, and some doses could start rolling out the very next day if the shot snares a swift authorization. It remains unclear how long the review process will take. Story

Merck struck a $425 million cash deal to buy OncoImmune and its coronavirus treatment CD24Fc, aimed at the sickest COVID-19 patients. Interim data from a phase 3 trial showed improvements against the virus after a separate study showed gains in stem cell transplant patients earlier this year. Currently Merck has two COVID-19 vaccines in the clinic and an antiviral in phase 2/3 development. Story

AstraZeneca’s COVID-19 vaccine candidate can be stored and transported at normal refrigerator temperatures for at least six months, allowing it to be easily administered in a wider variety of healthcare settings — including in low- and middle-income countries. These properties could give the viral-vector shot a logistical leg up over its mRNA-based rivals, which require ultra-cold storage. Story

Following its FDA authorization over the weekend, the federal government will begin distributing Regeneron’s antibody therapy on Tuesday, starting with more than 30,000 courses of treatment, according to a report from Reuters.

The NIH awarded nearly $45 million to expand its efforts aimed at providing access to COVID-19 diagnostics among underserved populations. The federal program added 20 institutions across seven states and territories to its research network, bringing its total funding amount to over $283 million and 55 participating organizations.

A mathematical model by the University of Colorado at Boulder showed that screening half the U.S. population regularly with cheap, rapid COVID-19 tests could help completely eliminate the virus within weeks. Combined with personal quarantines, restaurants and schools would be able to stay open, the researchers said.

UPDATED: Monday, Nov. 23 at 9:15 a.m. ET

On average, two separate regimens of AstraZeneca’s vaccine candidate proved 70% effective in late-stage trials, the drugmaker said. Most subjects — 8,895, to be exact — received two full doses of the shot, which boasted 62% efficacy in that group. Meanwhile, a smaller cohort of 2,741 subjects got a half-dose for their first shot, followed by a booster; efficacy was 90% in that arm. Nobody who received the shot was hospitalized or had a severe case of COVID-19 and no serious side effects linked to the vaccine have been confirmed, AZ said. Story

AstraZeneca should have enough of its candidate vaccine to produce 200 million doses by year-end, with enough drug substance to crank out 700 million doses globally by the end of 2021’s first quarter, operations exec Pam Cheng said Monday. The drugmaker will keep the “active” drug substance in stock as it awaits approval worldwide, she added. The company aims to provide the U.K. with about 4 million finished doses this year, followed by an estimated 40 million doses in Q1, though AZ could double that supply if it proceeds with an initial half-dose, Cheng said.

Regeneron’s antibody cocktail bagged an emergency nod from the FDA Saturday to treat mild- to-moderate, non-hospitalized patients at high risk for progressing to severe COVID-19. The therapy — a combination of the monoclonal antibodies casirivimab and imdevimab — was shown to reduce viral load significantly better than placebo in a phase 1/2 trial and, more importantly, lowered the risk of hospitalization within 28 days. Regeneron aims to make the treatment available for around 80,000 patients this month and 300,000 patients by the end of January. Story

Pfizer and BioNTech’s vaccine hopeful could win U.K. authorization in as little as a week — ahead of U.S. clearance, government sources told The Telegraph. British regulators are about to start their assessment of the shot, and the country’s National Health Service has been told to prepare to start administering the vaccine by Dec. 1. Pfizer has pledged to provide 10 million doses to the U.K. this year out of a total 40 million-dose order.

India’s Bharat Biotech expects its vaccine hopeful, Covaxin, to boast at least 60% efficacy, Sai Prasad, president of quality operations at the company, said. Bharat kicked off phase 3 trials on Nov. 20 and plans to launch its shot in 2021’s second quarter. Covaxin is being developed in collaboration with the Indian Council of Medical Research’s National Institute of Virology.

UPDATED: Friday, Nov. 20 at 3:05 p.m. ET

Novartis pitched in $50 million upfront to snare a global license to develop and market Mesoblast’s cell therapy remestemcel-L in COVID-19. The FDA last month rejected Mesoblast’s filing for the treatment in children with steroid-resistant graft-versus-host disease, though the company in May had already kicked off a phase 3 trial to see whether its cell therapy could help COVID patients with acute respiratory distress syndrome. Novartis, which already boasts an approved cell therapy, will also help scale up commercial manufacturing to meet pandemic demand. Story

Cue Health’s rapid, point-of-care coronavirus diagnostic test will be shipped out to Alaska, Florida, Louisiana, New Jersey and Texas in a government pilot program under the Department of Health and Human Services. The molecular test, which uses nasal swabs and a cartridge-based reader that sends results to a connected smartphone, won FDA authorization in June, and should tee up diagnoses in healthcare settings with larger groups of people at high risk for COVID-19, like nursing homes and long-term care centers. Story

A pre-engineered version of Adagio’s experimental antibody, ADG20, protected against SARS-CoV and SARS-CoV-2 — the virus that causes COVID-19 — in mice, the company reported on the preprint site bioRxiv. In lab tests, the drug was also able to neutralize two related coronaviruses circulating in bats — potentially giving it an edge over other antibodies in the works, which tend to trade breadth of activity in multiple viruses for potency against SARS-CoV-2 specifically, said Laura Walker, Ph.D., chief scientists at Adagio. Story

Serum Institute of India, which has already produced millions of doses of AstraZeneca’s vaccine candidate, will seek emergency approval in-country as soon as regulators in the U.K. clear the shot for use among the general public, CEO Adar Poonawaala said. The company is almost on “autopilot” as it awaits vaccine results; SII can then start cranking out “hundreds of millions” more doses, Poonawalla said.

The United States, the European Union and several other wealthy nations on Friday pushed back on a proposal to waive certain intellectual property rights for COVID-19 drugs and vaccines, Reuters reports, citing three trade sources. That lack of support means the proposal will likely fail when it goes before the World Trade Organization next month. The waiver has been backed by a slate of developing countries, China, the World Health Organization and Médecins Sans Frontières.

Hungary’s plans to test and potentially produce Russia’s controversial Sputnik V vaccine could strain its relationship with the European Union and undermine public confidence in a vaccine, the European Commission said. The vaccine must be authorized by the European Medicines Agency before it can go out to EU states, though the regulator says it has yet to receive any data from Russia. Meanwhile, Hungary on Thursday imported its first doses of Sputnik V, which it will study to “make a well-founded decision on potential usability and approval,” the country’s foreign minister said.

UPDATED: Friday, Nov. 20 at 9:29 a.m. ET

Eli Lilly and Incyte’s rheumatoid arthritis med Olumiant, in tandem with Gilead’s Veklury (remdesivir), won an emergency nod from the FDA to treat hospitalized COVID patients requiring oxygen support, mechanical ventilation or extracorporeal membrane oxygenation. An NIAID trial of the drug showed patients on the combo had a median recovery time of seven days, compared to the placebo and Veklury arm’s eight days. Patients on the combo were also less likely to die or need mechanical ventilation after 29 days and had better odds of improvement at day 15 versus the control group. Story

Meanwhile, a World Health Organization panel on Thursday advised against the use of Gilead’s Veklury to treat COVID-19. The panel’s guidance, published in the journal BMJ, “concluded that the evidence did not prove that remdesivir has no benefit; rather, there is no evidence based on currently available data that it does improve patient-important outcomes.” Gilead, for its part, told The Wall Street Journal it was “disappointed” that the WHO’s Veklury guidelines came at a time when cases are mounting worldwide. Story

The European Union has agreed to pay €15.50 ($18.34) per dose for Pfizer and BioNTech’s vaccine candidate, Reuters reports, citing an EU official close to the matter. That would put the EU on the hook to pay up to €3.1 billion ($3.7 billion) for its 200 million-dose order, rising to €4.65 billion ($5.51 billion) if the bloc chooses to purchase another 100 million doses. Separately, the EU confirmed it would pay €10 ($11.84) per dose for CureVac’s mRNA-based vaccine, for an initial supply of 225 million doses. The block this week secured up to 405 million doses of CureVac’s shot hopeful.

Roche is poised to start delivering Regeneron’s two-antibody cocktail in 2021’s first quarter, CEO Severin Schwan told Bloomberg. An emergency nod for Regeneron’s antibody cocktail could be granted “very soon,” though initial demand is sure to outstrip supply, Schwan said. The companies will have a combined capacity of roughly 2 million doses next year. Meanwhile, Roche is working to ramp up production as fast as possible, Schwan added.

Sinovac could have phase 3 data on its vaccine hopeful, CoronaVac, by next month, Weining Meng, senior director of the Chinese biotech, said Friday. The shot is in late-stage testing in Brazil, Indonesia and Turkey. Sinovac earlier this week published early- to mid-stage data showing CoronaVac sparked a swift immune response but lower antibody levels than those seen in patients who’ve recovered from COVID-19.

ApiJect Systems on Thursday was approved by the U.S. government for a $590 million loan to produce single-dose injectors for COVID-19 vaccine candidates. ApiJect’s self-contained device has yet to pass the FDA’s bar, prompting health experts to question the government’s loan. The company, meanwhile, plans to build a facility with capacity for 3 billion pre-filled injectors annually. The facility would be able to support candidates that require standard cold storage or ultra-cold storage up to -94 degrees Fahrenheit — the temperature required for Pfizer’s vaccine. Story

UPDATED: Thursday, Nov. 19 at 3:20 p.m. ET

Pfizer and its German partner BioNTech plan to file for an emergency use authorization for their shot in the U.S. Friday, BioNTech CEO Uğur Şahin told CNN. Depending on the speed of the review process, the partners’ vaccine could snare authorization or conditional approval in 2020, with distribution efforts kicking off before year-end, Şahin said. Pfizer on Wednesday announced its vaccine had shown 95% efficacy in phase 3.

Meanwhile, BioNTech is working on a new formulation for its shot that could enable shipping at room temperature, Şahin said during his CNN interview. The development process is happening “in parallel” with Pfizer and BioNTech’s current efforts and could bear fruit as early as the second half of 2021, he said. Concerns have mounted over storage and shipping requirements for the partners’ candidate, which must be kept at -94 degrees Fahrenheit — far colder than than the requirement for most vaccines.

And Pfizer aims to start distributing its vaccine “within hours” of scoring an emergency nod, starting with shipments wherever the shot is cleared first, CEO Albert Bourla told Sky News. This could spark a “race to regulate” as authorities hustle to review data and lock down doses for their countries, he added. If one regulator OKs the shot before another, the “ethical” move would be to start sending doses to people in that jurisdiction, though patience is crucial, since demand will outpace supply early in the vaccination process, Bourla said. Story

AstraZeneca’s vaccine could launch with little lag behind Pfizer and Moderna’s candidates, currently at the head of the pack, Andrew Pollard, head of the University of Oxford’s vaccine trial, said. Still, he emphasized that AZ and Oxford aren’t rushing, nor are they competing with other developers. Phase 3 data is expected before Christmas, at which point it will be sent off to regulators. If that process moves at a pandemic-appropriate pace, “it’s possible that things could line up so there is not very much difference in timing between the various different vaccines,” Pollard said.

Siemens Healthineers developed a quantitative test that measures the antibodies able to neutralize coronavirus. The IgG antibody test — a new version of the serology test Siemens launched over the summer, which estimates the numbers of coronavirus antibodies in a person’s bloodstream — boasts a CE mark in Europe and is under review for emergency use at the FDA. The test should help gauge the level of immunity conferred by a vaccine, and the company plans to make it available internationally via its Atellica, Advia Centaur and Dimension laboratory hardware. Story

The Department of Health and Human Services (HHS) put the kibosh on a $15 million contract that would have helped secure celebrities to feature in the agency’s controversial $250 million ad campaign to “defeat despair and inspire hope” amid the pandemic. While Hollywood will no longer make an appearance, HHS is pressing on with a new, “science-based” approach to its campaign. Story

Médecins Sans Frontières (MSF), also known as Doctors Without Borders, has called for governments to support a request to waive certain intellectual property rights on COVID-19 drugs and vaccines during the pandemic, slated for consideration at an upcoming World Trade Organization meeting. Kenya, Eswatini, India and South Africa are co-sponsoring the waiver, which so far has the support of 99 countries. “All COVID-19 health tools and technologies should be true global public goods,” Sidney Wong, executive co-director of MSF’s Access Campaign, said.

UPDATED: Thursday, Nov. 19 at 9:30 a.m. ET

In late October, AstraZeneca teased phase 2 data showing its vaccine spurred an immune response in patients both young and old. Now, those results have been peer reviewed and published in The Lancet. Healthy adults over the age of 56 showed a similar immune response to that of younger patients, and the oldest participants, whose median age was between 73 and 74, experienced milder side effects than the younger cohort. AZ’s phase 2 enrolled 560 adults, 240 of whom were over the age of 70. Story

If Pfizer’s shot wins an emergency nod, vulnerable groups — most likely healthcare workers, first responders and elderly Americans living in nursing homes — could start receiving the vaccine in December, HHS secretary Alex Azar said Tuesday. By January, there should be enough Pfizer doses for everyone in that initial group and by March or early April, Azar expects to have enough vaccines from Pfizer and other developers for all Americans.

Roche’s arthritis med Actemra, also known as tocilizumab, hit a “key efficacy endpoint” among seriously ill COVID-19 patients. It’s unclear if the drug helped people stay alive or shortened the time on intensive care support like mechanical ventilation, though more details should be published in a matter of weeks, Anthony Gordon, lead investigator of the 303-patient trial, said.

Later today, the U.S. International Development Finance Corp (DFC) will likely reveal that it’s extended its $590 million loan to ApiJect — maker of an unproven injection device still awaiting FDA clearance, NPR reports. The single-use device is meant to offer an alternative to vials and syringes, supplies that could become strained as shots start to roll out. Having a backup plan for glass vials is important, but the fact that the government has invested so much in a technology that has yet to go through the FDA is cause for concern, one health expert told the news outlet.

Close to 1 million people have received Sinopharm’s experimental COVID-19 vaccine, the Chinese drugmaker said Wednesday. Since July, the country has allowed essential workers and other limited groups to take three separate vaccine candidates — two from Sinopharm and one from Sinovac — none of which have completed phase 3 testing. No serious side effects have been reported by those receiving the experimental shot in emergency use, Liu Jingzhen, chairman of Sinopharm, said, though it’s unclear which vaccine he was referring to.

The concept of “herd immunity” comes with some big caveats, health experts told Reuters. It would not imply individual protection from the virus, since the thrust of the idea is to protect the vulnerable. Meanwhile, we still don’t know how fast the virus spreads under normal circumstances, without travel and social restrictions in place, Winfried Pickl, professor of immunology at the Medical University of Vienna, said. Finally, while the first vaccines poised to hit the market will likely prevent individual COVID-19 cases, they may not stop the spread of the virus to unvaccinated individuals.

UPDATED: Wednesday, Nov. 18 at 2:50 p.m. ET

The FDA approved Lucira Health’s all-in-one COVID-19 diagnostic, which people over the age of 14 can use at home with a prescription. The kit — which relies on a swab and aims to deliver results in about 30 minutes — shrinks a molecular test for the virus’ genetic code down to a handheld unit, complete with all the necessary chemical reagents. The company expects the test to become available nationwide early next spring with a price tag of $50. Story

AstraZeneca and the University of Oxford have enlisted research services firm CCT Research to help recruit 1,500 patients for a vaccine trial in Arizona. CCT works as a clinical site network, embedding research studies within local communities. The Arizona trial, slated to run at Bayless Integrated Healthcare’s site in downtown Phoenix, will compare AZ’s shot hopeful against placebo in healthy patients over the age of 18. Story

Johnson & Johnson over the next five years will invest $100 million to help address racial inequities in healthcare, drawn into sharp focus against the backdrop of COVID-19. J&J’s efforts are threefold: work with local communities; expand and add partnerships; and increase internal efforts to hire and promote people of color to the management level and above. In one snapshot of the drugmaker’s community outreach efforts, J&J plans to grow its support of mobile health clinics — already delivering COVID-19 testing and information on clinical trial inclusivity — for communities of color. Story

With cases mounting in the U.S., drug and vaccine trials are receiving an unexpected tailwind, The New York Times reports. Moderna, which announced positive early results on its shot hopeful Monday, had originally aimed to submit data to experts after observing 53 COVID-19 cases in its phase 3 trial, but higher infection rates allowed the biotech to base its readout on 96 sick subjects. Enrollment in Regeneron’s antibody cocktail trial has also hastened this month, a company spokeswoman told the news outlet.

In late October, 58% of Americans said they would get a COVID-19 vaccine — up eight points from a low of 50% in September, a new Gallup poll found. Meanwhile, 42% of the 2,985 American adults surveyed said they definitely wouldn’t get a vaccine, down slightly from 50% in September. Thirty-seven percent from that group cited rushed vaccine development as the main cause for concern, while another 26% said they wanted to wait for confirmation that an approved shot is safe.

Hummingbird Bioscience could roll out its experimental antibody in Singapore and other countries by early 2021, Jerome Boyd-Kirkup, co-founder of the company, told CNBC. Small-scale trials of the treatment, dubbed Hummingbird 115, kicked off in Singapore last month, with phase 3 studies expected to start in December. “We’re aiming for early 2021 for widespread accessibility of this therapy to patients,” Boyd-Kirkup said.

UPDATED: Wednesday, Nov. 18 at 9:25 a.m. ET

Pfizer has obtained the necessary follow-up safety data to pursue an emergency nod for its shot, CEO Albert Bourla , Ph.D., said. The company on Wednesday published detailed data from its phase 3, which showed its mRNA-based vaccine was 95% effective. In the control group, 162 patients developed COVID-19, compared to eight subjects in the vaccine arm. Nine severe cases were observed in the placebo group, versus the vaccine cohort’s one. Story

Roche successfully tested its ability to churn out large quantities of Regeneron’s experimental antibody cocktail and is ready to kick off manufacturing should the treatment snare approval, George Yancopoulos, Regeneron’s chief scientific officer, told Reuters. The Swiss drugmaker could start producing the treatment in 2021’s first quarter, a Roche spokesperson added. Regeneron is on deck to provide 300,000 doses of its treatment to the U.S. as early as January, with 50,000 doses already stockpiled.

Sinovac’s experimental vaccine can induce an antibody response within four weeks of immunization by giving two doses of the shot at a 14-day interval, the Chinese biotech said in a publication of its phase 1/2 trial in the journal Lancet Infectious Diseases. Sinovac’s early- and mid-stage tests took place in April and May. The biotech is now plowing ahead with late-stage trials, although one phase 3 study was stopped in Brazil this month after reports of a serious safety scare. Story

Meanwhile, Brazil’s Sao Paulo state will start importing an initial 46 million doses of Sinovac’s shot this week, which could be made available in January if the vaccine passes muster with local regulators, the director of the state’s Butantan Institute biomedical center said. Butantan, which is organizing phase 3 trials of the shot in-country, said last week’s pause was unrelated to the vaccine. Meanwhile, Brazil said it would also look to purchase Pfizer’s vaccine if the shot is proven effective and registered with the country’s health authority, Anvisa.

With lives at stake, the Trump Administration needs to share critical COVID-19 data with President-elect Joe Biden’s team, including information on the supply of therapeutics, testing materials, personal protective equipment, ventilators, hospital bed capacity and workforce availability, the American Medical Association, the American Nurses Association and the American Hospitals Association said. Leaders from the trio of healthcare juggernauts signed a letter making their position known a day after Biden warned that more people would die if Trump failed to concede.

It will likely take weeks to determine whether a potential vaccine is worthy of an emergency nod, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, told Business Insider. Marks added that the FDA will make the process “very open” and said he hopes the extra review time will help boost faith in a final product. “Everything that we are trying to do here, this is all about ensuring the public re-develops the kind of trust they once had in vaccines.” Story

Celltrion will likely pursue an emergency nod for its monoclonal antibody, CT-P59, in South Korea before year-end, group chairman Seo Jung-jin said. The company is currently “wrapping up” a phase 2 trial of the drug, he added. Earlier this year, the company announced that its antibody could shorten patients’ recovery time with no reported side effects, adding that the drug could neutralize the virus within four to five days, potentially protecting patients with mild symptoms from developing severe disease.

A scant 15% of airlines feel prepared to transport Pfizer’s vaccine hopeful at the required, ultra-cold temperature of -94 degrees Fahrenheit, a recent survey by an air cargo association and drug shipper’s group found. Around 60% said they’d be able to transport Moderna’s shot candidate, which must be kept at -4 F. Meanwhile, as airlines scramble to lock down specialized shipping containers, cold storage specialists like Cryoport and Germany’s va-Q-tec have seen shares soar, Reuters reports. Story

UPDATED: Tuesday, Nov. 17 at 3:16 p.m.

The U.K. hastily secured 5 million doses of Moderna’s vaccine candidate Monday, hours after the biotech unveiled positive phase 3 data on its mRNA-based shot, health secretary Matt Hancock said. The U.K. chose not to purchase Moderna’s vaccine earlier this year over concerns about vaccine nationalism and Moderna’s then-lack of a dependable European supply chain, The Guardian reported, citing sources close to the matter. Moderna has since signed on manufacturing partners in Switzerland and Spain.

The FDA postponed its decision on Bristol Myers Squibb’s CAR-T hopeful liso-cel — picked up in its $74 billion Celgene buyout — thanks to COVID-19 restrictions that kept the regulator from inspecting a Lonza facility in Texas, slated to help churn out viral vectors for the cell therapy. The FDA did not provide a new anticipated action date, BMS said, dimming hopes of a liso-cel approval before year-end. Story

Infectious disease experts now expect a COVID-19 vaccine by May 2021 — a month sooner than previously predicted — but that slightly sped-up timeline is joined by growing reluctance to give an authorized shot to patients, a new survey by InCrowd showed. Just 47% of U.S. infectious disease experts said they would feel “highly confident” in prescribing an FDA approved vaccine, InCrowd’s October survey found. Respondents further predicted that 40% of patients would also be wary of getting the vaccine.

Ohio Republican Sen. Rob Portman will roll up his sleeve to take part in Johnson & Johnson’s phase 3 vaccine trial. He hopes the move will encourage others to enroll in ongoing U.S. shot studies and reassure the public about the safety and efficacy of vaccines once they’ve moved through clinical trials and the FDA.

New Jersey-based CDMO Cambrex is plugging $50 million into four additional active pharmaceutical ingredient (API) facilities at its Charles City, Iowa, small-molecule drug site. The investment is set to boost capacity by 30% and meshes with the CDMO’s goal to offer stateside API production to drugmakers looking for a “reliable” supply chain. U.S. lawmakers have called for more investment in domestic drug production this year as the pandemic puts pressure on an increasingly global pharmaceutical supply chain. Story

China’s plan to vaccinate the public with unproven shots may be working too well, The New York Times reports. Five-hundred doses sent to the city of Yiwu were snapped up in a matter of hours. Other cities are limiting doses and asking people to prove they are traveling to qualify. Meanwhile, scalpers are charging as much as $1,500 for vaccine appointments, the news outlet wrote. And while China says it’s monitoring vaccinated patients, a consent form for one candidate reviewed by the Times made no mention of the fact that the product was still in testing.

UPDATED: Tuesday, Nov. 17 at 9:13 a.m.

Pfizer kicked off a pilot delivery program for its vaccine in Rhode Island, Texas, New Mexico and Tennessee, selecting the states for their differences in size, diversity, vaccine infrastructure and patient populations split between rural and urban areas, Reuters reports. Pfizer’s BioNTech-partnered shot must be stored and shipped at -94 degrees Fahrenheit, fueling recent concerns about widespread storage and distribution.

Germany’s CureVac is ramping up manufacturing to produce “pandemic scale” volumes of its vaccine candidate, CVnCoV, the drugmaker said in a release. The company plans to build an integrated European manufacturing network, leveraging CDMOs for each step of the production process. CureVac aims to boost vaccine capacity to upward of 300 million doses in 2021 and up to 600 million doses by 2022. It’s also working on an additional, large-scale production facility at its headquarters in Tübingen, Germany. Story

Samsung Biologics is mass producing Eli Lilly’s recently authorized monoclonal antibody, bamlanivimab, the South Korean drugmaker said Tuesday. Samsung in May entered a production deal with Lilly and said it has a long-term contract with the antibody developer, but didn’t share further details. Lilly is gunning to produce 1 million doses of its antibody by year-end and expects supply to increase in 2021 as more manufacturing resources go live. Story

Meanwhile, U.S. hospitals are already facing high demand and tight supplies of Lilly’s antibody, Reuters reports. At $1,250 per dose, the U.S. has so far bought 300,000 doses of bamlanivimab — enough for about a week’s worth of new infections at the current rate, health experts said. Doctors also called for “more conservative criteria” on who should be eligible for the treatment; under the current label, the drug is OK’d to treat older patients recently diagnosed with mild to moderate disease, as well as those with risk factors like obesity and diabetes.

India’s Bharat Biotech launched a 26,000-person phase 3 trial of its vaccine candidate, Covaxin, developed with the Indian Council of Medical Research. Volunteers will receive two injections of either vaccine or placebo 28 days apart, and Bharat plans to monitor patients over the next year to screen for incidences of COVID-19. The trial is both India’s “first phase 3 efficacy study for a COVID-19 vaccine” and the largest late-stage efficacy trial ever conducted in the country, Bharat said in a statement.

The Indian government is in talks with Moderna after the Massachusetts-based biotech unveiled strong data on its mRNA-based vaccine hopeful Monday, the Hindustan Times reports. The country is also holding discussions with domestic vaccine makers like Serum Institute of India, Bharat and Zydus Cadila, along with Pfizer, for potential shot doses, the news outlet reported, citing a senior government official.

UPDATED: Monday, Nov. 16 at 3:07 p.m.

After several months of discussion, the European Union has agreed to purchase up to 405 million shot doses from German vaccine maker CureVac, European Commission President Ursula von der Leyen said. The commission will authorize the deal on Tuesday and expects a signature to come sometime this week, she added. If the shot passes muster in the clinic, the EU would receive 225 million initial doses, with the option to later purchase another 180 million. CureVac in September snared $299 million in German funding for its vaccine work. Story

Former FDA commissioner and Pfizer board member Scott Gottlieb suggested the entry of two “highly effective” vaccines into the market — namely Pfizer’s and Moderna’s — “could effectively end this pandemic in 2021,” CNBC reports. Gottlieb’s prediction hinges on the efficacy of those mRNA-based shots once full data are released, combined with the fact that many people will have already had COVID-19 by 2021.

But even with mRNA vaccines from Pfizer and Moderna posting strong data in rapid succession, it’s essential that people not become complacent about the virus, the World Health Organization warned Monday. The agency is concerned about mounting case numbers — particularly in Europe and the U.S. — as health workers and healthcare systems in those regions are “pushed to the breaking point,” WHO Director-General Tedros Adhanom Ghebreyesus said via Twitter.

States, cities and hospitals across the U.S. are vying for ultra-cold freezers as Pfizer’s vaccine rollout looms, Reuters reports. The CDC in August told healthcare providers not to invest in specialty freezers for the shot — which must be stored at -94 degrees Fahrenheit — as it works on its own solution. Meanwhile, states like California, Rhode Island and New Mexico told the CDC they anticipate challenges due to limited freezer supplies, while around half a dozen states said they’re looking to secure their own units.

New York, California, Connecticut, West Virginia and the District of Columbia have established committees to vet a potential COVID-19 vaccine once it passes the FDA’s bar, while Washington, Oregon and Nevada are each adding a representative to California’s panel. The effort, primarily in Democratic-led states, follows mounting vaccine skepticism and concerns that the Trump Administration has prioritized speed above all else in the race for a vaccine. Some health experts, like HHS’ deputy chief of staff for policy, Paul Mango, fear those states’ reviews could undermine the FDA.

Meanwhile, social media has become a battleground for vaccine misinformation, fueling skepticism that could prevent the U.S. from controlling the virus’ spread once a shot is approved, Richard A. Stein, M.D., Ph.D., an adjunct professor at the NYU Tandon School of Engineering and senior editor with the International Journal of Clinical Practice, told Yahoo Finance. Facebook, for its part, has started placing links to the CDC’s website on the pages of certain groups circulating false information, while YouTube has started demonetizing anti-vaccine content.

UPDATED: Monday, Nov. 16 at 9:30 a.m. ET

Moderna’s mRNA-based vaccine candidate boasted nearly 95% efficacy in the first interim analysis of the drugmaker’s phase 3 data. The review covered 95 confirmed cases from the study — 90 from the placebo arm and five cases from the group that received the shot, dubbed mRNA-1273. The company submitted data on 11 severe cases of COVID-19, all recorded in the control group. No significant side effects were observed, and Moderna said it would use the data to file for an emergency nod “in the coming weeks.” Story

Moderna’s shot should remain stable at 36 degrees Fahrenheit to 46 degrees Fahrenheit — about as cold as your standard fridge — for 30 days, new stability testing unveiled by the company shows. Moderna had earlier estimated its vaccine could remain at those temperatures for around a week. Meanwhile, the shot could be kept for up to six months when stored at -4 F, or standard freezer temp. Once removed for administration, the shot can remain at room temperature for up to 12 hours, Moderna said. Story

The European Commission hailed Moderna’s “encouraging” vaccine results. The bloc is inking a supply deal with Pfizer and BioNTech later this week, with “more to come soon,” EU health commissioner Stella Kyriakides said.

Johnson & Johnson on Monday kicked off a phase 3 trial assessing a two-dose regimen of its vaccine hopeful. The company aims to enroll up to 30,000 subjects; 6,000 are expected to be recruited in the U.K., along with subjects from countries with high case counts, including Germany, Belgium, Spain, the Philippines and the U.S. Participants will receive a second dose of vaccine or placebo 57 days after their first doses, J&J said, with the aim to test whether an additional shot will help protect against the disease for longer. Story

Strong data on Pfizer’s shot candidate could convince more people to get vaccinated, NIAID director Anthony Fauci, M.D., told Bloomberg. “What I would hope is that even though there’s a degree of skepticism about vaccines in general, that when the general public sees how effective this vaccine is, we might see a turnaround of the attitude toward vaccination,” he said. Last week, Pfizer announced its shot had so far shown more than 90% efficacy in phase 3.

President-elect Joe Biden’s coronavirus team plans to meet with major vaccine makers this week, including Pfizer, Biden’s newly elected chief of staff, Ron Klain, said. President Donald Trump’s failure to concede the election has hindered the transition of power, keeping Biden’s top health officials from working with the government, Klain said. Manufacturing and distribution will pose a significant early challenge to Biden’s team. To that end, it’s crucial the transition team meet with the HHS “as quickly as possible,” Klain added.

Come spring, Russia aims to mainly produce a freeze-dried version of its vaccine, Sputnik V, in a bid to eliminate ultra-cold shipping requirements, Reuters reports. Currently, Russia’s shot must be kept at -18 degrees Celsius, or -0.4 degrees Fahrenheit, but the country is working on a lyophilized, powdered version that should remain stable at 35.6 F to 46.4 F. Russia plans to mainly produce that version starting in February, the head of the country’s sovereign wealth fund said.

UPDATED: Friday, Nov. 13 at 3:32 p.m. ET

Operation Warp Speed is seeking White House approval to connect with President-elect Joe Biden’s transition team, Moncef Slaoui told the Financial Times. Slaoui, a GlaxoSmithKline vet who heads up the government program, said he wants to make sure the effort remains on track, no matter the administration in charge, and he needs a green light from President Donald Trump’s team to reach out to Biden’s. Trump so far has refused to concede the election, complicating the transition of power.

Qiagen kicked off marketing and distribution of its QIAreach antigen test in the U.S., where the portable diagnostic is under FDA review for emergency lab use. The company hopes to amend the authorization before year-end to enable use in hospitals and other point-of-care settings, and it’s pursuing an in vitro diagnostic CE mark in Europe. QIAreach uses a digital hub and interchangeable test-stick cartridges to process more than 30 samples per hour. Story

The European Society of Intensive Care Medicine says Gilead’s remdesivir, now known as Veklury, should not be used in COVID-19 patients requiring critical care, the group’s president, Jozef Kesecioglu, told Reuters. The European medical association and the U.S. Society of Critical Care Medicine will state the recommendation in an upcoming paper on COVID-19 meds, Kesecioglu added. The advice follows a large WHO study that found the antiviral did little to help hospitalized patients. Gilead, for its part, has contested those results. Story

Patients taking the popular over-the-counter sleep aid melatonin were 28% less likely to test positive for COVID-19, a new study from the Cleveland Clinic found — though more testing is needed before the supplement could be widely used in treatment, the study’s senior author said. Researchers used an AI tool to screen data from 26,779 people in the clinic’s COVID-19 registry, of whom 8,274 tested positive. Story

The antidepressant fluvoxamine, if taken within the first week of COVID-19 symptoms, could reduce the risk of breathing problems and hospitalization in patients with mild disease, a study from the Washington University School of Medicine in St. Louis found. The COVID-19 Early Treatment Fund will provide additional funding to the university for an 880-person trial to confirm the results.

Among those benefiting from Pfizer’s strong vaccine results this week? German brothers Andreas and Thomas Struengmann — founders of the generic drugmaker Hexal, bought by Novartis in 2005. The pair have collectively grown about $8 billion richer this year thanks to their stake in Pfizer’s German mRNA partner, BioNTech, BNN Bloomberg reports. Back in 2008, the brothers helped to give BioNTech €150 million in startup funds. They now own around half of the company.

In recent months, state hackers from Russia and North Korea have targeted “seven prominent companies directly involved in researching vaccines and treatments for COVID-19” in Canada, France, India, South Korea and the U.S., said Tom Burt, Microsoft VP of customer security and trust.

Tesla’s Elon Musk may have COVID-19, but he wouldn’t know it from the tests he’s taken. Musk was tested four times Thursday, all with the same BD rapid antigen test, receiving two positive and two negative results, he alleged on Twitter. “Something extremely bogus is going on,” he said. Musk’s view on the pandemic has been divisive — he later tweeted that the daily testing rate has gone “ballistic” in the U.S. and implied mounting case numbers were due to false positives.

The U.S. recorded more than 160,000 new cases Thursday, a little more than a week after logging 100,000 new infections in a single day for the first time, The New York Times reports. Meanwhile, COVID-19 hospitalizations reached 67,096 Thursday, setting a record for the third straight day, the news outlet said.

The U.S. has an undeniable “independent spirit,” but it’s time for the public to start following the rules when it comes to preventing the coronavirus’ spread, NIAID director Anthony Fauci said. Speaking with other health experts at Washington National Cathedral Thursday, Fauci acknowledged that it’s difficult to compare the U.S.’ coronavirus response to other nations, given the country’s size, but argued that stricter adherence to public safety guidelines would likely prevent another lockdown.

UPDATED: Friday, Nov. 13 at 9:56 a.m. ET

A vaccine ought to be required once one is proven safe and effective, Roche Chairman Christoph Franz told the Swiss newspaper Handelszeitung. He acknowledged that such a move would be controversial, but argued that a mandate would create “freedom in other areas” by halting the virus’ spread and potentially ending lockdowns. Franz’s statement is his own “personal opinion,” Roche told Reuters. The Swiss drugmaker isn’t developing a COVID shot but has teamed up with Regeneron to help produce its antibody cocktail.

The pressure is on for China to share data on its COVID-19 vaccine candidates. Brazil suspended a late-stage trial of Sinovac’s shot on Monday after a serious patient health scare — right around the time Pfizer revealed its BioNTech-partnered vaccine had so far shown more than 90% efficacy in phase 3. Now, lack of transparency threatens to put China’s vaccine diplomacy in jeopardy, health and political experts warn.

Shanghai-based Fosun, which has exclusive rights to Pfizer and BioNTech’s shot in the Greater China region, has ID’d a storage site near the Hong Kong airport that could allow the drugmaker to store large amounts of the shot at ultracold temperatures, South China Morning Post reports. Meanwhile, some experts raised concerns that cold-chain hurdles associated with Pfizer’s product may outweigh the potential benefits in China.

Meanwhile, Fosun snared a green light from China’s National Medical Products Administration to run a phase 2 trial of Pfizer and BioNTech’s mRNA-based vaccine hopeful in-country.

And Israel secured 8 million doses of Pfizer’s shot — enough to vaccinate around half of the country’s population of 9 million — Prime Minister Benjamin Netanyahu said. Pfizer confirmed Thursday a deal was in the works but did not divulge financial details. Deliveries are expected to start in January if the shot wins out in the clinic, Netanyahu said. Israel also has an agreement with Moderna for future purchase of its mRNA-based candidate.

Switzerland’s drug regulator Swissmedic kicked off a rolling review of Moderna’s vaccine candidate, mRNA-1273, potentially teeing up a swift approval for the Massachusetts-based biotech’s shot. The process will allow Swissmedic to screen data from ongoing clinical trials as soon as it becomes available. Moderna last month completed enrollment for its phase 3 vaccine study and yesterday announced it had accrued enough cases for the first interim analysis.

The U.K. is weighing whether to tap U.S. data analytics company Palantir to improve the country’s struggling contact tracing program, which has been hit with IT glitches, slow testing turnaround, user errors and more since its launch. The move could prove controversial, however; civil liberties groups have knocked Palantir for its work with the U.S. immigration service and for its links to national security agencies; the optics of the company handling hundreds of thousands of personal case contacts per week “are just not good,” a person familiar with the talks told the Financial Times.

Synairgen’s inhaled formulation of interferon beta-1a was well-tolerated in hospitalized COVID-19 patients and led to greater odds of recovery than placebo, and more quickly, too, the company said in a release. One hundred and one patients received either the drug or placebo once daily for 14 days. Those on Synairgen’s drug, dubbed SNG001, were also more likely to recover to “no limitation of activity” during treatment, the drugmaker said. Story

Hungary is set to receive a sample of Russia’s controversial vaccine within a week-and-a-half for laboratory testing, with plans to kick off clinical studies in December, the country’s minister of foreign affairs and trade said. If all goes to plan, Hungary would become the first EU member state to trial Russia’s shot. The United Arab Emirates, Saudi Arabia, Indonesia, the Philippines, India, Brazil, Mexico and former Soviet republics have so far expressed interest in the vaccine.

And Russia on Wednesday said its shot candidate, Sputnik V, has so far shown 92% efficacy in a late-stage trial. The data are based on the first 16,000 patients who received either the shot or placebo in Russia’s 40,000-person phase 3. Researchers were able to confirm 20 COVID-19 cases among that group, split between those given the vaccine and the control arm. The results are set to be published in a peer-reviewed journal, Russia’s sovereign wealth fund said.

UPDATED: Thursday, Nov. 12 at 3:15 p.m. ET

While mRNA vaccines from Pfizer and Moderna are already in phase 3, German biotech CureVac is touting a storage advantage for its midstage candidate. The late-stage shots require storage at subzero temperatures, complicating distribution and use, while CureVac’s candidate can be kept at refrigerated temperatures. Story

Incorporating GlaxoSmithKline’s adjuvant technology, Canadian biotech Medicago pushed its COVID-19 vaccine into phase 3 testing. The plant-derived vaccine candidate recently succeeded in a phase 1 trial, but it’ll now face a bigger and more important study. Story

A few days after Eli Lilly scored an FDA emergency use authorization for bamlanivimab, analysts are concerned the med’s restrictive label may shrink sales of that medicine and Regeneron’s antibody, which is under FDA emergency consideration. Story

Johnson & Johnson, in phase 3 testing with its COVID-19 vaccine, is well on its way to producing 1 billion doses in 2021 as planned and is looking ahead to 2022, VP of strategic initiatives Paul Lefebvre said in an interview. While manufacturing has set back some players, the company took a deliberate approach in preparing to deliver on its lofty goals. Story

The early data for Pfizer and BioNTech’s mRNA vaccine candidate “open the floodgates” for the vaccine technology for infectious diseases, SVB Leerink analyst Daina Graybosch said in an interview. But that doesn’t mean the tech will succeed in other disease areas. Story

UPDATED: Thursday, Nov. 12 at 9:22 a.m. ET

Moderna hit the needed number of patient infections in its phase 3 vaccine trial to move ahead with the first interim analysis. Because of a significant uptick in observed COVID cases across trial sites last week, the drugmaker expects its first data analysis to cover substantially more than 53 cases — the target required to kick off an initial review of its mRNA shot.

AstraZeneca’s cancer med Calquence failed to help patients hospitalized with respiratory symptoms of COVID-19, the drugmaker said in a release. The BTK inhibitor missed its primary endpoint in the drugmaker’s phase 2 to “increase the proportion of patients who remained alive and free of respiratory failure.” No new safety signals arose, AZ said.

In the race for a vaccine, drugmakers aren’t competing with one another, but against the virus itself, Johnson & Johnson CEO Alex Gorsky said. “The best possible position we could be in is where we have four or five or six of these vaccines available in the year 2021,” he said. Gorsky said that mounting case numbers underline the importance of sustained efforts to prevent the virus’ spread, adding that the pandemic has exposed a need to improve public health worldwide.

Amgen and Japanese drugmaker Eisai signed on to University of Pittsburgh Medical Center trial aiming to use artificial intelligence to assess and adjust COVID-19 treatments. Amgen’s newly acquired Otezla (apremilast) and Eisai’s experimental eritoran — both anti-inflammatory drugs — will be evaluated by reinforcement learning, a type of AI that can modify treatment protocols in real time according to data on each patient’s reaction to the drug.

Meanwhile, Serum Institute of India completed enrollment for its phase 3 trial of AstraZeneca’s vaccine candidate, the company said in a statement. The Institute has so far produced 40 million doses of the shot. AZ’s vaccine is the ‘most advanced’ shot in clinical testing in the country, the Indian Council of Medical Research said.

Médecins Sans Frontières (MSF) wants governments to push drugmakers to open the books on their vaccine licensing deals so that the public, countries and treatment providers can secure shots at a fair price. “As long as we don’t know what’s in these deals, pharma will continue to hold the power to decide who gets access when, and at what price,” said Kate Elder, senior vaccines policy advisor for MSF’s Acces Campaign. The current lack of transparency puts equitable access to a COVID-19 vaccine “in jeopardy,” she added.

A viral mutation could dampen hopes for the leading pack of vaccines, which tackle the current version of the virus, Bloomberg analyst Sam Fazeli wrote in an op-ed. He cited Denmark’s recent culling of its mink population after the virus spread through the animals and mutated before jumping back into humans. Meanwhile, mutations could easily crop up in people too, if the virus continues to spread unchecked.

Mallinckrodt is teaming up with Pharmerit to run a retrospective chart review study assessing its INOmax nitric oxide gas as an inhalation therapy for patients with COVID-19 respiratory complications. The drug is approved to treat respiratory failure associated with pulmonary hypertension in infants. The partners will collect data from around 200 hospitalized patients treated with INOmax for at least 24 hours between January 1 and July 31 of this year.

UPDATED: Wednesday, Nov. 11 at 3:00 p.m. ET

Vaccines from Johnson & Johnson and Sanofi and Novavax may be better suited to global distribution than Pfizer’s candidate, which requires two doses and ultracold storage. J&J’s shot, in testing at a single dose, is expected to remain stable for two years at minus 20 degrees Celsius and for upward of three months at refrigerator temps. Meanwhile, Sanofi and GSK’s two-dose recombinant protein vaccine can be stored at 35.6 to 46.4 degrees Fahrenheit, a spokeswoman said. Story

Pfizer is already weighing options for a second-generation version of its vaccine, including a powder formulation that could eliminate the need for ultracold storage, chief scientific officer Mikael Dolsten told Business Insider. That formulation, storable via refrigeration, could roll out as early as next year, he added. Story

On Monday, as strong efficacy data on Pfizer’s shot raised the company’s shares nearly 8%, CEO Albert Bourla sold off 132,508 shares, more than 60% of his total holdings, for $5.6 million. Bourla sold the shares under a SEC rule that allows company insiders to arrange stock sales in advance, before they have access to “material nonpublic information.” Story

Kaiser Health News posed a slate of questions about Pfizer’s vaccine after Monday’s data reveal. The length of immunity conferred by the shot and its efficacy in at-risk groups topped the list. KHN also wondered whether a quick authorization could derail ongoing trials of other candidates, among other things.

More than a few people are struggling with the name for Eli Lilly’s antibody therapy bamlanivimab, which won an emergency OK on Tuesday in non-hospitalized COVID patients at high risk of severe disease. The tongue-twisting drug name even received some gentle ribbing on Fallon Tonight:

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Try saying that 5… or 9 times fast! #FallonTonight
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Meanwhile, Qiagen teamed up with cell therapy-focused startup TScan Therapeutics to develop a COVID-19 diagnostic designed to offer a comprehensive profile of a person’s immune response to the disease. TScan will pivot its genome-based, high throughput discovery platform for parsing T-cell receptors to determine how those immune cells react to COVID-19. By focusing on T cells rather than antibodies — which may diminish over time — TScan figures its test could offer a more reliable way to screen for the virus over a longer period after infection. Story

UPDATED: Wednesday, Nov. 11 at 9:30 a.m. ET

Pfizer and BioNTech clinched a deal to supply 200 million doses of their experimental vaccine to the EU, with an option for another 100 million doses. The partners will crank out shots at BioNTech’s German manufacturing sites and Pfizer’s production site in Belgium, and aim to start deliveries by year-end, should the vaccine pass muster in the clinic. Story

And if everything goes to plan with Pfizer’s data submission, the U.S. could start immunizing people in December, Health Secretary Alex Azar said. Pfizer expects to have safety data for an emergency nod as early as next week. After authorization, the U.S. would receive around 20 million doses per month and aim to vaccinate nursing home residents, healthcare workers and first responders by the end of January.

WHO director general Tedros Ghebreyesus welcomed “promising news” on the efficacy of Pfizer and BioNTech’s vaccine, while reiterating the agency’s commitment to fair distribution of an eventual shot. Ultracold storage requirements for the partners’ mRNA-based vaccine have raised concerns about access in low- and middle-income regions. Meanwhile, the shot “presages significant cold-chain challenges for African countries,” the WHO’s regional director for Africa said.

And the Indian government ought to hammer out a vaccine distribution strategy to ensure Pfizer’s shot is made widely available, lawmaker Rahul Gandhi said Wednesday. For its part, Pfizer is “exploring opportunities” to make the shot available in-country, the drugmaker told Business Standard. The country’s health secretary confirmed India was in talks with Pfizer and said it could could strengthen its cold-chain capacity for the vaccine.

Rural hospitals in the U.S. also lack funds to secure the ultracold freezers needed to store Pfizer’s vaccine, Stat reports. The CDC has recommended against state health departments purchasing the high-end freezers, given that other shots with less stringent storage requirements are likely on the way. Meanwhile, areas with smaller populations may struggle to use up Pfizer’s 1,000-to-5,000 dose shipments before they expire. Pfizer, for its part, is working on smaller-dose shipments for 2021.

Plus, states say they still lack government funding necessary to meet widespread vaccination goals in the U.S. The CDC in September announced $200 million in grants designed to support shot planning, while organizations representing state health officials and immunization managers have called for around $8.4 billion more, the Chicago Tribune reports. Among the mounting costs states will face? Securing ultracold freezers, setting up and staffing vaccination centers, running vaccination messaging campaigns and more.

Meanwhile, the technology behind Pfizer and BioNTech’s vaccine may have lasting effects beyond the COVID-19 pandemic. “It provides a glidepath for using mRNA technology for other vaccines, including cancer, autoimmune disorders, and other infectious diseases, as well as vehicles for genetic therapies,” said Peter Hotez, vaccine researcher and dean at Baylor’s National School of Tropical Medicine. “It really does help accelerate the whole biomedical field.”

New daily cases in the U.S. passed 139,000 yesterday as COVID-19 hospitalizations hit an all-time high of 61,964, The New York Times reports. The country is now averaging more than 111,000 new cases per day, according to The Times’ database.

UPDATED: Tuesday, Nov. 10 at 3:12 p.m. ET

CureVac, advancing an mRNA vaccine candidate, unveiled more data showing that the vaccine triggers potentially protective immune responses. Still it isn’t known whether the vaccine can match the high efficacy bar just hit by Pfizer and BioNTech’s vaccine in interim data, and tolerability questions linger. Story

Investigators paused a trial of a vaccine in development by China’s Sinovac after a participant died in Brazil. A source told Reuters the death was a suicide. FierceBiotech story | Reuters story

After Pfizer unveiled positive interim findings for its mRNA vaccine Monday, HHS secretary Alex Azar said in network interviews the government has plans in place to begin vaccinations next month and into January, contingent on a review of the data and regulatory recommendations. Reuters story

Four months after launching, Massachusetts biotech Adagio Therapeutics scored an $80 million series B to push its COVID-19 antibody into the clinic next year. FierceBiotech story

UPDATED: Tuesday, Nov. 10 at 9:15 a.m. ET

Amid ongoing hype — and questioning — about Pfizer’s vaccine results, CEO Albert Bourla told CNBC he’d be willing to get the vaccine first to ease concerns about its risk-benefit profile — but he’s not sure that would be ethical given other populations might need it more. Forbes story

Pfizer partnered with Germany’s BioNTech to advance the vaccine, which was originally developed by the husband-and-wife duo of Ugur Sahin and Oezlem Tuereci. Both are the children of Turkish immigrants. Reuters story

As it was advancing the program, Pfizer prioritized transparency, diversity and funding independence. There are numerous reasons behind those decisions, including vaccine skepticism, a failed historical experiment and more, outlined in a new Marketplace article.

Since Pfizer unveiled the results in a Monday press release, scientists have been pushing for more details. The “encouraging” figures are still the “earliest of results possible,” Mayo Clinic vaccine researcher Gregory Poland told Reuters. It also isn’t clear yet how well the vaccine protects older trial participants, whether it reduces severe disease or how long protection lasts. Another vaccine expert, Peter Hotez, told Science it’s “always hard to read the tea leaves of a company press release.” Reuters story | Calgary Herald story | Science story

While the vaccine data are “very good news,” science writer Laurie Garrett pointed out that serious concerns remain, including the pandemic’s current resurgence in the U.S. and the lame-duck leadership in federal government. Plus, there’s much more to learn about the vaccine given the current state of the research.

President Donald Trump on Twitter alleged Pfizer waited to share the early data until after the election. Bourla, for his part, told CNN the company delivered the news “when the science told us the data was available.” Business Insider story

The vaccine is expected to reach different countries at different time. India’s Economic Times reports that country won’t see it “anytime soon” and that ultracold temperature requirements would make it tough for a national immunization strategy there. The U.S., U.K. and other countries have placed advanced orders, the report says. Story

In China, Fosun Pharma’s stock price soared after the news on hopes that the company will be able to launch the shot there. The drugmaker is partnered with BioNTech and may be able to launch after a bridging study, the South China Morning Post reports.

After efforts to re-purpose medicines and manufacture needed drugs to help fight the pandemic, Africa’s Aspen is pivoting to focus on vaccines. The company recently signed on to help manufacture Johnson & Johnson’s candidate. Bloomberg story

And as Novavax pushes forward with its late-stage candidate, the company is moving to raise $500 million through stock sales. The biotech recently picked up an FDA fast track designation.

UPDATED: Monday, Nov. 9 at 3:28 p.m. ET

After Pfizer reported promising efficacy data for its vaccine, experts and analysts started weighing how other companies might fare with their own programs. Because Moderna is also advancing an mRNA program, the company is in a solid position with its mRNA-1273, experts said.

The Pfizer results “provide strong validation” of the mRNA vaccine platform, Chardan analyst Geulah Livshits wrote to clients. The biotech’s vaccine has less restrictive cold chain requirements than Pfizer’s does, so its program wouldn’t necessarily need to meet the 90% efficacy mark to be used widely, the analyst wrote. In all, the Pfizer news is an “important positive read-across” for Moderna given the biotech’s significant investment in its mRNA vaccine franchise.

Anthony Fauci, director of the NIAID, also said the Pfizer news bodes well for Moderna. Speaking with Stat, Fauci said Moderna “will likely have similar results.”

Still, Evercore ISI analyst Josh Schimmer said the mRNA vaccines take longer to scale up than the subunit adjuvant program at Novavax and the viral vector program from AstraZeneca. The “right mix of approved vaccines” could mean adequate supply for the U.S. and well beyond” by next year’s first quarter, he said. But if it’s all up to mRNA vaccine players to deliver the needed doses, it could be the third quarter before adequate supplies are available.

Meanwhile, positive vaccine news could raise questions for companies working on leading COVID-19 therapeutics. Gilead, Eli Lilly and Regeneron are key players, and Barclays analysts wrote that the Pfizer news “should raise further questions around the mid-to-long-term durability” of revenue from potential coronavirus therapeutics. The analysts noted that drugs will still be needed even after vaccines launch. Story

UPDATED: Monday, Nov. 9 at 9:23 a.m. ET

Pfizer and BioNTech’s vaccine candidate, BNT162b2, boasted more than 90% efficacy in preventing COVID-19 in patients without prior evidence of infection, interim data from the partners’ phase 3 showed. That number could change as more data roll in, Pfizer said. The interim analysis covered 94 patients; the company will need to submit data on 164 patients and build up at least two months’ worth of safety data before it can file for an emergency nod, potentially around Thanksgiving. Story

Novavax’s recombinant nanoparticle-based vaccine won fast track designation from the U.S. Food and Drug Administration. The drugmaker aims to kick off late-stage trials in the U.S. and Mexico by the end of November and expects an ongoing phase 3 in the U.K. to complete enrollment in that same timeframe. Interim data from that trial could be ready as early as the first quarter of 2021, Novavax said.

President-elect Joe Biden plans to convene a 12-member coronavirus task force Monday, led by former surgeon general Vivek Murthy and ex-FDA commissioner David Kessler. Biden has already set forward a number of COVID-19 goals, including doubling the number of drive-through testing sites, establishing a U.S. public health job corps and boosting production of masks, face shields and other protective equipment.

Plus, some Biden advisers have already met with drug and vaccine makers that are part of the government’s Warp Speed program, Bloomberg reports. According to the news service’s sources, advisers told the companies that his administration wouldn’t want to disrupt the program’s work in getting new drugs and vaccines to market. Instead, it wants to be ready to help when Biden moves into the Oval Office.

Serum Institute of India has produced up to 30 million vials of AstraZeneca’s vaccine hopeful, dubbed Covishield in-country, the joint commissioner of the Pune division of the Food and Drug Administration said. The company is now seeking an emergency license for the shot. Results from an Indian phase 3 are expected by year-end, and Serum Institute has kicked off production to meet demand ahead of an authorization.

Meanwhile, AstraZeneca agreed to supply around 22 million vaccine doses to Argentina, with plans to start distributing the shots in the first half of 2021. That delivery timeframe is subject to the success of ongoing trials and local regulatory approval, AZ said in a statement circulated by the Argentine government Saturday.

Sanofi, Eli Lilly Korea and Roche Korea are tapping their early retirement programs to scale back sales forces amid the COVID-19 outbreak, Korea Biomedical Review reported. The move comes as more drugmakers turn to digital sales tools — a transition already in the works back in 2019 and accelerated by the pandemic. Specifically, Sanofi plans to encourage some of its chronic disease sales reps to choose early retirement, while Lilly aims to dial back drug reps in the country by 20%.

UPDATED: Friday, Nov. 6 at 9:19 a.m. ET

Novartis’ arthritis med Ilaris, also known as canakinumab, failed to keep seriously ill patients off ventilators and didn’t beat standard of care at preventing deaths, phase 3 data showed. The trial tested the drug in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome. Novartis is also testing Jakafi against the disease and joined forces with Molecular Partners in October to develop two DARPin therapies as potential treatments.

AstraZeneca plans to bring ex-U.S. vaccine data before the FDA once it obtains results from its British, South African or Brazilian trials — even if those data precede a readout from the drugmaker’s U.S. phase 3, EVP of biopharmaceuticals R&D Mene Pangalos told Reuters. The FDA has set expectations for safety and efficacy, but hasn’t said those data must come from U.S. studies, Pangalos said, adding that an approval would be unlikely to disrupt its ongoing stateside trial.

The U.K.’s Recovery Trial on Friday started investigating aspirin to see whether the cheap and widely-available drug could reduce the risk of blood clots in hospitalized COVID patients. The trial expects to dose at least 2,000 patients with aspirin plus standard of care and will primarily assess mortality after 28 days. The researchers are also curious whether the drug can reduce the length of hospitalization and need for ventilation.

Regeneron is optimistic the FDA will authorize its antibody cocktail but still doesn’t know the timeline for that decision, CEO Leonard Schleifer said on a Thursday earnings call. The company earlier this year said clinical data showed the drug reduced medical visits in patients with mild or moderate disease. Regeneron could make about 80,000 doses available by the end of this month and have 300,000 doses ready by the end of January, the company said. Story

Amgen staffers who have worked remotely since March will continue to work from home until the end of June 2021, Judy Brown, SVP and site head at Amgen’s global headquarters, said in an email obtained by Acorn. Brown reasoned that the Greater Los Angeles area, where the company is based, is unlikely to see a drop in cases before spring, adding that a vaccine probably wouldn’t become available during that timeframe, either.

UPDATED: Thursday, Nov. 5 at 3:55 p.m. ET

Hologic’s revenue may have slipped last quarter, but its COVID-19 testing business has continued to soar, helping the company net more than $1.3 billion in sales in the final quarter of its 2020 fiscal year. The company’s molecular diagnostics division alone managed to pull $818.9 million for the period — almost as much as the $865.8 million in total revenues Hologic made during the last quarter of 2019. Story

Children with COVID-19 produce fewer, weaker antibodies than adults, a study published in Nature Immunology found. While both adults and children in the study produced COVID-19 antibodies, children mainly produced one kind, called IgG, which binds to the virus’ spike protein. Adults, meanwhile, made multiple types of antibodies — better than IgG at neutralizing the virus — that bound to the spike protein and other viral proteins, too.

Contract research organization Parexel teamed up with bioanalytics firm Synexa Life Sciences and blood-drawing specialist Drawbridge Health to offer Synexa’s serology test, which can help identify whether a person has had a virus such as SARS-CoV-2, and Drawbridge’s OneDraw remote blood collection device to customers as part of the company’s myriad COVID-19 projects and trials. Parexel cited an “urgent need” for accurate serology testing that also limits risk of exposure to COVID-19 — which it thinks its new pact can deliver on. Story

The time has come for the U.S. to develop a testing strategy to track asymptomatic spread of COVID-19, CDC director Robert Redfield said. The CDC in August issued a recommendation that people who had come into close contact with an infected person didn’t necessarily need to get tested unless they were at higher risk of infection or severe disease. The agency changed its tune in September, urging anyone who has been in close contact with an infected individual to get tested, even if they don’t display symptoms.

An oversight panel called for changes at the World Health Organization, stressing that it was essential the agency maintain “neutrality and political independence.” The panel urged the U.N. agency to establish a graded system to “alert and engage the wider international community at an earlier stage in a health crisis,” and also said the WHO’s Emergency Program is in “a constant struggle to mobilize resources, with staff forced to juggle competing priorities simultaneously.”

UPDATED: Thursday, Nov. 5 at 9:30 a.m. ET

AstraZeneca is poised to supply “hundreds of millions” of vaccine doses on a rolling basis once its shot is authorized, CEO Pascal Soriot told Bloomberg, despite delays in early U.K. shipments. Soriot added that a recent resurgence in cases had enabled scientists to gather necessary clinical data. A day earlier, Kate Bingham, chair of the UK Vaccine Taskforce, had said just 4 million AZ doses would be ready by year-end in the U.K., rather than the 30 million doses the drugmaker had hoped to deliver by September.

Chile’s drug regulator green lighted a clinical trial of AstraZeneca’s vaccine, the country’s President, Sebastian Pinera, said. The AZ study joins a Chilean trial of Johnson & Johnson’s shot, plus a separate test of Sinovac’s pandemic hopeful. The country has penned a deal for 10 million doses of Pfizer and BioNTech’s shot and is looking to ink similar agreements with AstraZeneca, J&J and Sinovac, Pinera said. Elsewhere, Peru said J&J and AZ would kick off vaccine trials in the country next week.

And Bangladesh locked down 30 million AstraZeneca doses through Serum Institute of India (SII). The country will purchase 5 million doses from SII per month through Bangladeshi drugmaker Beximco, provided the shot is cleared by regulators, the country’s health minister said.

The World Health Organization is going all-in on monoclonal antibodies, dexamethasone and repurposed meds — but not Gilead’s Veklury (remdesivir) — in its scheme to provide COVID-19 drugs to low-income countries, an internal document obtained by Reuters showed. Unitaid, a health partnership co-leading the effort, confirmed that the scheme would not include Veklury, though it didn’t comment on the reason for excluding the antiviral. A WHO trial reported in October found Gilead’s drug offered little benefit in COVID-19 patients; Gilead has disputed those findings.

The U.S. charted more than 107,800 new COVID-19 cases Wednesday, according to The New York Times, setting a grim record for daily infections. Meanwhile, Maine, Minnesota, Indiana, Nebraska and Colorado also hit single-day case records.

Bharat Biotech could launch its shot as early as February, jumping ahead of its previously stated second-quarter rollout goal, a senior scientist at the Indian Council of Medical Research (ICMR) told Reuters. Bharat plans to kick off a late-stage study of its shot, Covaxin, this month. “It is expected that by the beginning of next year, February or March, something would be available,” he added.

UPDATED: Wednesday, Nov. 4 at 3:00 p.m. ET

Britain will receive an estimated 4 million doses of AstraZeneca’s vaccine by year-end, rather than the 30 million doses AZ had hoped to supply by September, UK Vaccine Taskforce chief Kate Bingham told lawmakers Wednesday. Earlier in the day, the chief investigator of the University of Oxford’s vaccine trial said he was “optimistic” that AZ could deliver late-stage trial data before year-end, adding that doses were already in production. The U.K. in May penned a deal for 100 million doses of AZ’s shot, which should now be available in the first half of 2021, Bingham said.

Russia aims to provide its citizens with tens of millions of doses of its Sputnik V vaccine by year-end, but production and quality control hurdles may deflate that number, The Bell reported. “We can’t stabilize the vaccine, no one yet can,” an unnamed exec at one of the Gamaleya Institute’s four Russian manufacturing partners told the news outlet. Meanwhile, vaccine batches frequently miss the institute’s quality control bar and attempts to launch bioreactors at scale have been “generally unsuccessful.”

A COVID-19 breathalyzer test from Singapore’s Breathonix achieved at least 90% accuracy when screening participants on-site for 60 seconds, the company said. An ongoing pilot study in 180 people showed an overall sensitivity of 93% and a specificity of 95%. The test, which uses a one-way valve and disposable mouthpiece, could be used for mass screening in high-traffic areas, Breathonix figures. Story

BD inked a contract with the Dutch Ministry of Health to supply an initial 1.2 million units of its rapid antigen diagnostic, the hand-held Veritor Plus system, this month, with another 8 million slated for delivery to the Netherlands by June of next year. The portable, point-of-care system won an emergency coronavirus nod from the FDA in July and a CE mark in September. Story

The FDA on Tuesday warned healthcare professionals that antigen tests could deliver false positives if users fail to follow instructions. The regulator encouraged labs to perform follow-up testing with a molecular assay when appropriate and cautioned that improper storage, failure to read testing results at the correct time and cross-contamination could all lead to inaccurate readouts. The warning follows reports of false positives from antigen tests in nursing homes and other healthcare settings.

UPDATED: Wednesday, Nov. 4 at 9:12 a.m. ET

Australia locked down 40 million vaccine doses from Novavax, plus 10 million doses from Pfizer and BioNTech, bringing the country’s total vaccine investment up to more than $3.2 billion. If the shots win approval, they’re expected to become available in Australia during the first half of 2021. The country earlier this year secured doses from AstraZeneca and the University of Queensland.

China’s Fosun Pharma stopped development on BioNTech’s first COVID-19 vaccine and will instead seek Chinese approval for the German shot maker’s second candidate, currently in late-stage testing in the U.S. Fosun aims to run a bridging study that may enable it to use global data on the second candidate, BNT162b2. Pfizer and BioNTech chose that shot as their phase 2/3 candidate after it turned up a lower rate of side effects than their first prospect. Story

Speaking of Pfizer and BioNTech, the chair of the UK Vaccine Taskforce, Kate Bingham, is hopeful that strong interim data from the mRNA partners, plus AstraZeneca and the University of Oxford, will emerge in early December, potentially teeing up a vaccine rollout before year-end.

For its part, the University of Oxford is “optimistic” that it could unveil late-stage results on its AstraZeneca-partnered shot this year, said chief investigator of the university’s vaccine trial, Andrew Pollard. As for whether the shot might be available before Christmas, “[there] is a small chance of that being possible but I just don’t know,” he said, adding that a shot would not be a panacea. “We will still have people getting this virus because it is just too good at transmitting.” Story

In people with symptomatic COVID-19, Quidel’s rapid Sofia test was able to detect more than 80% of cases found by the slower, gold-standard PCR test — but when Quidel’s test was used to randomly screen asymptomatic patients, it only picked up 32% of infections caught by the PCR method, a University of Arizona study found. It’s possible the rapid test missed asymptomatic cases ID’d by the lab test because those people were carrying too little of the virus to spread it to others, one study author said.

The U.S. FDA ordered NovaBay Pharmaceuticals to stop claiming that its Avenova antimicrobial eyelid and eyelash spray can kill the SARS-CoV-2 virus. The company’s website asserts that “an independent third-party laboratory study” confirmed its spray can fully inactivate the virus and recommends using it to eliminate airborne respiratory droplets. In a warning letter, the FDA pointed out that the NovaBay spray has no human data to back it up.

UPDATED: Tuesday, Nov. 3 at 3:16 p.m. ET

While most vaccine makers will pass their shots off to McKesson for U.S. distribution, Pfizer is taking matters into its own hands, Tanya Alcorn, VP for biopharma global supply chain at the company, said. Pfizer has developed a GPS and temperature-tracked thermal cooler to help transport its vaccine, along with a control tower that provides real-time alerts if temperatures deviate or a shipment runs late. Still, some officials remain concerned that vaccination centers won’t have the cold-storage capabilities to house Pfizer’s shot. Story

T cell immunity to the coronavirus may outlast antibodies in patients who’ve recovered from COVID-19, a recent U.K. study showed. Analyzing the blood of 100 patients six months after they had asymptomatic or mild disease, researchers found that while antibody levels dropped in some patients, T cell response endured. T cell response was also higher in patients who displayed symptoms while infected.

61,000 new coronavirus cases cropped up in children last week, more than any previous week in the pandemic, the American Academy of Pediatrics (AAP) reported. Severe illness due to COVID-19 in children is rare, but there is an “urgent need” to collect more data on the long-term impact of the disease in kids, AAP said.

Colorado State University is using the fecal matter and pooled spit of undergraduates to catch COVID-19 cases early, Kaiser Health News reports. The school’s sewage review follows emerging research suggesting people shed the virus in feces early in their infections. The school is also conducting “paired” pooling of saliva samples, which allows testing of multiple samples at once without the need for much retesting if a pool of samples turns up positive.

UPDATED: Tuesday, Nov. 3 at 9:30 a.m. ET

Advocacy group Public Citizen urged Gilead Sciences to give up the priority review voucher it earned alongside its FDA approval of Veklury, also known as remdesivir. The voucher can be used to speed up FDA review time for another drug or sold — and previous sales have netted hundreds of millions of dollars. Public Citizen called the incentive “unnecessary” and “inappropriate” given Gilead’s expected Veklury sales. Story

The Coalition for Epidemic Preparedness Innovations (CEPI) will fund development of Clover Biopharmaceuticals’ protein-based S-Trimer vaccine through a global phase 2/3 trial, bringing its total investment in the program to upward of $328 million. Beyond the upcoming efficacy trial, pegged to start before year-end, CEPI’s investment will fund studies in people with autoimmune conditions, children, pregnant women and more. If the shot clears the clinic, Clover and CEPI aim to make hundreds of millions of doses available per year through the WHO’s Covax effort. Story

Israel dosed the first two patients in a phase 1 trial of its coronavirus vaccine, Brilife, developed by the Israel Institute for Biological Research. A phase 2 trial that seeks to enroll 960 healthy volunteers is expected to kick off in December, while a 30,000-person phase 3 is pegged to start in April or May 2021 if warranted.

The pandemic is entering a new, “deadly phase,” White House coronavirus coordinator Deborah Birx said in a private memo to White House officials obtained by The Washington Post. Birx called for consistent messaging about masks, hand-washing and social distancing. It’s not about lockdowns, she wrote, but rather, “an aggressive balanced approach that is not being implemented.” Her comments put her at odds with President Donald Trump, who says the nation is “rounding the corner” on the pandemic.

Scientists at the University of Washington School of Medicine developed a nanoparticle vaccine candidate that sparked neutralizing antibody levels in mice ten times higher than those seen in recovered patients — and at a much lower dose than required for vaccination with the SARS-CoV-2 spike protein. The University licensed its candidate to Icosavax for further study. Amgen agreed to manufacture a key intermediate for initial R&D while South Korea’s SK Bioscience advances its own studies on the shot.

South Korea’s new minister for food and drug safety, Kim Gang-lip, made his first goal to “mobilize our regulatory capacity as much as possible to help develop a Covid-19 treatment and vaccine that people can trust.” Kim also aims to boost the Korean drug regulator’s global competitiveness and is seeking “international regulatory harmonization.”

UPDATED: Monday, Nov. 2 at 3:20 a.m. ET

CureVac aims to build an mRNA vaccine that generates a balanced immune response similar to the body’s natural reaction, and now it’s armed with interim phase 1 data supporting that goal. In the dose escalation study, CureVac’s highest 12-microgram dose — pegged to advance into a phase 2b/3 — raised binding and neutralizing antibody levels to those seen in a set of 67 seriously ill COVID-19 patients, the company said. Story

Pfizer and Bristol Myers Squibb launched a new campaign to promote doctor visits amid the pandemic. “No Time to Wait,” which covers broadcast and streaming TV and radio, as well as digital and social media, focuses on three conditions: atrial fibrillation, deep vein thrombosis and pulmonary embolism, all treated by the partner’s anticoagulant Eliquis. Story

Johnson & Johnson’s weekly video series, “The Road to a Vaccine,” has racked up more than 100 million views since launching in April. Hosted by journalist Lisa Ling, the show features J&J researchers and execs, public health officials and advocates in conversation about vaccine development, mental health, racial disparities and more. “At the end of the day, science is about society, and society has to understand the processes of science,”J&J communications exec Seema Kumar said of the series during Fierce Pharma Marketing’s Digital Pharma Innovation Week. Story

Massachusetts-based biotech incubator LabCentral, together with lab facility provider BioLabs, launched the Cambridge Consortium for Rapid COVID-19 Tests (CCRCT) to assess and validate COVID-19 diagnostics that people can use at home. CCRCT last month started a trial of a 15-minute, self-administered antigen test made by LabCentral alum E25Bio. Story

Hologic snared a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, with the goal to provide 13 million COVID tests per month by January 2022. The company’s Panther Fusion and Aptima SARS-CoV-2 assays won emergency nods in March and May, respectively, and the FDA in September OK’d Hologic’s Panther Fusion test to screen asymptomatic patients. Story

Novavax inked a 15-year lease for about 122,000-square-feet of offices in Gaithersburg, Maryland, for manufacturing, office space and R&D, while an affiliate of the company bought 9.7 acres in Gaithersburg for future development. Novavax has scored up to $2 billion from the U.S. government and CEPI for its COVID-19 vaccine program; the company’s shot is currently in late-stage testing in the U.K. and a large phase 3 trial in the U.S. and Mexico is set to kick off later this month. Story

Fifty-nine percent of Russians say they wouldn’t get the country’s Sputnik V vaccine, an October poll from Russia’s Levada Center showed. That number rose from 54% of respondents unwilling to get the shot in August. Meanwhile, just 31% of people polled in October said they would get the shot, down nearly nine percentage points from August. Levada polled 1,601 Russians between Oct. 22 and Oct. 28.

UPDATED: Monday, Nov. 2 at 9:15 a.m. ET

Johnson & Johnson hopes to start testing its vaccine in children ages 12 to 18 as soon as possible, said Jerry Sadoff, a vaccine research scientist at J&J’s Janssen unit. The company could eventually test its shot in even younger children, Sadoff said. The vaccine platform J&J’s using for its COVID-19 shot, AdVac, is also used in an Ebola vaccine that’s been given to infants, children and pregnant women.

Africa’s biggest drugmaker, Aspen Pharmacare, struck a preliminary deal to produce Johnson & Johnson’s vaccine in South Africa. The company would carry out manufacturing and packaging work at its Port Elizabeth plant, which boasts capacity for 300 million doses a year, if the shot snares regulatory approval in the country.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) awarded £1.5 million ($1.9 million) to GenPact for an artificial intelligence tool to process potential side effects and safety signals from an approved vaccine. Based on historical vaccination data, the MHRA expects to see between 50,000 and 100,000 side effect reports for every 100 million doses administered over a six to 12 month span.

Bharat Biotech aims to launch its vaccine hopeful in the second quarter of 2021, pending an approval in India, the company’s executive director said. The shot, Covaxin, has a ways to go: Bharat expects to kick off recruitment for a phase 3 trial this month.

At a rally early Monday morning, President Donald Trump floated the possibility of firing the nation’s top infectious disease expert, Anthony Fauci, after the election. During the event, Trump once again said the country has “turned the corner” on the pandemic. But in a Washington Post article published Saturday, Fauci said the U.S. “could not be positioned more poorly” ahead of the winter. Story

The U.S. needs to make an “abrupt change” in public health practices and behaviors to counter the pandemic, Anthony Fauci told The Washington Post. The coronavirus task force is meeting infrequently and has much less influence with the President now, Fauci said. And the NIAID chief said Scott Atlas, a neuroradiologist who has become Trump’s favored pandemic advisor is “a smart guy who’s talking about things that I believe he doesn’t have any real insight or knowledge or experience in.”

Meanwhile, Thanksgiving will be a COVID-19 “inflection point,” former FDA commissioner Scott Gottlieb said. “There are about 23 states that are accelerating the spread right now,” he added. It’s unlikely that the entire country would lock down again, as Europe is doing, though Gottlieb said he expects states to take local action as hospitals become overwhelmed.

The U.K.’s Department for Business, Energy & Industrial Strategy came to the defense of Kate Bingham, chair of the country’s vaccine task force, after The Sunday Times published an article alleging she had disclosed “sensitive” information about U.K. investments in COVID vaccines and therapeutics. Her presentation, for a U.S. women’s conference, had been cleared by the government, the department said, and Bingham said little that experts at the conference couldn’t deduce themselves.

Siberia-based drugmaker Pharmasyntez asked the Russian government for permission to produce a generic version of Gilead Sciences’ Veklury, or remdesivir, despite lacking a patent or license. The drugmaker wrote to Gilead in July but did not hear back, and it is now asking the Russian government for a compulsory license, which would allow it to make a remdesivir generic without Gilead’s OK.

Editor’s note: This article was corrected to show that the Department for Business, Energy & Industrial Strategy, not BIA, issued the statement about Kate Bingham.

COVID-19 tracker: Moderna vaccine snares U.S. emergency nod; Europe to review Pfizer, BioNTech’s shot Monday

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