MARKS: VACCINE EUAs WILL COME 'WITHIN A WEEK' OF AD COMMS — FDA will likely authorize Pfizer and Moderna's coronavirus vaccines "within about a week" after the agency's vaccine advisory committee reviews each shot, FDA's top vaccine expert Peter Marks said Thursday. "It will depend on the discussion at the advisory committees," he said during an event hosted by the American Medical Association. The panel will review Pfizer's shot on Dec. 10 and Moderna's on Dec. 17. Both vaccines have proven more than 90 percent effective, and Marks noted that FDA is "not compromising on safety." "We're getting there as fast as we can because we understand people are losing their lives to this virus, but we also understand that the only way we can save more lives is to get a large proportion of the population to take the vaccine," he added. FAUCI: UK 'REALLY RUSHED' PFIZER VACCINE APPROVAL — Anthony Fauci, the government's top infectious disease expert, criticized the British government's decision to greenlight a coronavirus vaccine as overly hasty on Thursday — contending that the country's approval process relied too heavily on drugmaker data and lacked sufficient scrutiny. Fauci lamented that Americans are already too skeptical of a potential vaccine, and said that if the U.S. "had jumped up over the hurdle here quickly and inappropriately to gain an extra week or a week-and-a-half" in the vaccine race, "I think that the credibility of our regulatory process would have been damaged." While the FDA takes time to review raw data from drugmakers and run its own analysis of trial results, the U.K. regulatory agency relies to a much greater extent on reports submitted by pharmaceutical companies. WARP SPEED CHIEF PREDICTS 100M VACCINATED BY END OF FEBRUARY — The United States could vaccinate 100 million people against the coronavirus by the end of February, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, told reporters on Wednesday. Slaoui's estimate is based on 20 million people receiving the Moderna or Pfizer vaccine this month, with another 30 million people in January and 50 million more in February. The first shipment of the Pfizer vaccine, about 6.4 million doses, will be sent out around Dec. 15 if the vaccine is authorized by then, OWS chief operating officer Gustave Perna said Wednesday. The government is also preparing to send out 12.5 million doses of Moderna's vaccine once it is authorized. SMALL STUDY SHOWS MODERNA VAX MAY PROVIDE LASTING PROTECTION — People who received the Moderna coronavirus shot had higher levels of antibodies three months after vaccination than people who had recovered from Covid-19 infections, according to a report published Thursday in the New England Journal of Medicine. "We don't yet know what levels of antibodies or types of immune cells will be required to protect against Covid infection," said the study's lead author, Alicia Widge, a vaccine researcher at the National Institutes of Health. "But it's a positive sign how high these levels are and how stable they are over time." The peer-reviewed finding is based on a comparison of 34 people who got the vaccine as part of a Phase I trial and 41 people who had recovered from confirmed coronavirus infections. PENCE HEADS TO CDC — Vice President Mike Pence is set to travel to the CDC today to visit employees at the agency's Emergency Operations Center. He is scheduled to hold a round table at noon to discuss Covid-19 vaccines and the planning for their distribution. PFIZER EXPLAINS WHY IT CUT VACCINE SUPPLY PROJECTIONS — Pfizer in early November quietly halved its estimate of how many doses of its coronavirus vaccine would be available this year — from 100 million to 50 million. Now we know why. Scaling up the raw material supply chain "took longer than expected," a company spokesperson said, confirming a report published Thursday by the Wall Street Journal. "It is important to highlight that the outcome of the clinical trial was somewhat later than the initial projection, requiring us to focus additional efforts on clinical trial production." Modifications to Pfizer's full-scale production lines in the U.S. and Europe are now complete and doses are being made at a rapid pace, the spokesperson said. Pfizer still expects to produce up to 1.3 billion doses in 2021. A spokesperson for HHS confirmed that the U.S. supply of about 20 million Pfizer vaccine doses by the end of the year remains accurate and takes into account Pfizer's supply chain issues. U.S. BUYS 650,000 MORE DOSES OF LILLY ANTIBODY — The U.S. government purchased 650,000 additional doses of Eli Lilly's antibody drug for about $813 million, it announced late Wednesday — though widespread shortages of the treatment are still expected. The government now has bought 950,000 doses of the drug, bamlanivimab, and will continue to distribute it to state health departments for free. But the need will continue to outstrip supply, as states are collectively seeing about 150,000 Covid-19 cases per day. ELLUME SEEKS AUTHORIZATION FOR OTC COVID TEST — Australia-based Ellume is asking FDA to grant emergency use authorization for its over-the-counter Covid-19 antigen test, CEO Sean Parsons told POLITICO. The test, which will cost about $30, is designed to be used at home and provides results in 15 minutes. Ellume says it compares favorably to lab-based PCR tests — correctly identifying 100 percent of negative samples and 96 percent of positive samples from people with symptoms. In people without symptoms, it identified 91 percent of positive samples and 96 percent of negative samples. "The noises coming out of the FDA from our perspective are positive," Parsons said. "They're discussing some of the finer points of labeling and packaging and the sorts of things that are talked about when they're satisfied with the data." Parsons said Ellume will be able to manufacture 100,000 tests a day in January before ramping up to around 1 million per day by the middle of 2021. FDA last month granted the first EUA for an at-home test, made by Lucira Health — but it's only available by prescription and costs around $50. The agency's diagnostics director Tim Stenzel hinted Wednesday an over-the-counter authorization is coming soon. "We're absolutely open to OTC and I would anticipate in the not too distant future we're going to start making some OTC determinations," he said. GIROIR BRIEFS BIDEN TEAM ON TESTING — A "number of senior recognizable individuals" on the Biden team attended a 90-minute virtual meeting Wednesday to be briefed on the policy and technical principles behind the Trump administration's decisions on coronavirus testing, said HHS testing czar Brett Giroir. "It's important for them to understand the issues around some of the pathways that we took so they get that insight," Giroir said. "My job is not to tell them what to do, but to explain to them, from my perspective, why we made the decisions we did and what I perceive as some of the drawbacks or advantages of different routes." | 
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