COVID-19 tracker: Moderna vaccine snares U.S. emergency nod; Europe to review Pfizer, BioNTechs sho

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