COVID VACCINES AS SOON AS MID-DECEMBER — Vaccine distribution could begin within days of an Dec. 10 expert panel discussion of Pfizer's shot, federal officials told state governors in a Monday call according to notes of the call obtained by POLITICO. "We strongly believe the vaccine distribution process could begin the week of December 14," Vice President Mike Pence said. It'd be a record turnaround for FDA review, especially since this will be the first coronavirus vaccine before its advisory committee. Officials promise that distribution will begin within 24 hours of FDA's green light. "Normally the FDA process would take four or more months after the submission of an application ... We will of course expedite the review," Commissioner Stephen Hahn said on the call. Between Pfizer and Moderna, just 40 million doses are available this year. Governors asked about their allocation with some, like Maine Governor Janet Mills, saying they were getting a third less than originally expected. Officials said that state census records contributed to the allocations, which are not yet public. "The cavalry is coming," said Pence, who acknowledged that cases are rising nationwide but said: "Our country has never been more prepared to combat this virus." The U.S. is nearing 200,000 new coronavirus cases a day. MODERNA SEEKS EUA FOR VACCINE; AD COMM SET FOR DEC. 17 — Moderna on Monday became the second company — behind Pfizer — to file for an emergency use authorization for its coronavirus vaccine. The FDA's independent vaccine advisory group will meet on Dec. 17 to review the Moderna data. The filing is based on a final analysis of its 30,000-person late-stage trial that showed the vaccine is 94.1 percent efficacious, based on 196 cases of Covid-19 reported among the study participants. The vast majority — 185 — occurred in people who got a placebo. All 30 severe cases took place in the placebo group, and one participant in the placebo group died of the virus, Moderna said. NOVAVAX PUSHES BACK U.S. VACCINE TRIAL — U.S. government-funded coronavirus vaccine developer Novavax said Monday that it's pushing back the start of its late-stage clinical trial in the U.S. and Mexico from late November to an unspecified date next month, Zachary writes. The delay comes as the company, which has received $1.6 billion from the Trump administration's vaccine accelerator Operation Warp Speed, said it's working on manufacturing-related issues with its contractor Fujifilm in North Carolina. The company also announced Monday that it fully enrolled another late-stage trial of 15,000 participants in the U.K. More than 25 percent of enrollees in the vaccine trial are over the age of 65, and a large proportion of participants had underlying medical conditions, Novavax said. Interim data from the U.K. trial are expected early next year. According to the trial's protocol , the independent data safety monitoring board will look at interim analyses of data after 66 Covid-19 infections in either the placebo or vaccine groups, and after 110 infections. The data are expected to serve as the basis for the vaccine's licensure application in the U.K., European Union and other countries, the company said. GAO: CDC SHOULD EXPLAIN SCIENCE BEHIND CHANGES TO TESTING RECS — HHS and CDC's rollout of Covid-19 testing recommendations "has not always been transparent, raising the risk of confusion and eroding trust in government," the Government Accountability Office wrote in a new report released Monday. Over the summer, CDC walked back a widely criticized guidance that left it up to local public health officials and health providers if asymptomatic close contacts of people with Covid-19 should be tested for the disease. GAO said that while it is not unexpected that recommendations by the government will change as more information about the pandemic emerges, HHS and CDC should disclose the scientific rationale for changes to testing guidelines. The federal health department agreed with the recommendation. | 
