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October 7, 2020

FDA releases strict new coronavirus vaccine criteria. Trump says they're a 'political hit job.'

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    FDA on Tuesday published guidance detailing the criteria that manufacturers of experimental vaccines against the novel coronavirus will be expected to meet to receive an emergency use authorization (EUA) from the agency, despite reports that the White House opposed the move.

    A vaccine approval is coming. Get ready to ask these 8 questions.

    US new coronavirus cases top 7.5M, deaths near 211K

    The new guidance comes as U.S. officials as of Wednesday morning reported a total of 7,529,400 cases of the novel coronavirus since the country's epidemic began—up from 7,486,900 cases reported as of Tuesday morning.

    According to data from the New York Times, the rates of newly reported coronavirus cases are "staying high" in 23 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arkansas, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, North Carolina, North Dakota, Oklahoma, South Dakota, Tennessee, Utah, Wisconsin, and Wyoming.

    Fourteen states that have had comparatively low case rates are now seeing those rates "going up," according to the Times. Those states are Connecticut, Delaware, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington.

    In the 17 remaining U.S. states and territories, rates of newly reported coronavirus cases are "staying low," according to the Times' analysis.

    U.S. officials as of Wednesday morning also reported a total of 210,750 deaths linked to the coronavirus since the country's epidemic began—up from 210,029 deaths reported as of Tuesday morning.

    FDA publishes EUA guidance for coronavirus vaccine candidates

    As the United States' numbers of new coronavirus cases and related deaths continue to grow, the country is watching to see when a vaccine against the virus might receive FDA's authorization. On Tuesday, FDA published guidance that suggests the United States is unlikely to see an FDA-authorized vaccine before the Nov. 3 presidential election, Axios' "Vitals" reports.

    According to STAT News, FDA in recent weeks has sought to bolster Americans' confidence in the agency and any vaccine it ultimately grants an EUA by promising to share as much data on potential coronavirus vaccines as possible and ensure that officials will adhere to science when reviewing the experimental vaccines. The effort comes amid reports that the agency has been facing political pressure to authorize a coronavirus vaccine before robust clinical trial data on the experimental vaccines' efficacy and safety is available—and particularly before the upcoming presidential election.

    FDA's latest guidance details several recommendations coronavirus vaccine candidates should meet when applying for an EUA, including a recommendation that data from Phase 3 clinical trials includes a median of at least two months' follow-up data on at least half of the volunteers who received the full vaccination regimen.

    Peter Marks, director of FDA's Center for Biologics Evaluation and Research, on Tuesday said, "We picked two months as something that was reasonably aggressive yet also somewhat kind of in the middle—not too aggressive, not too conservative."

    However, STAT News reports that the criteria likely mean a viable vaccine candidate won't be ready until mid-November or early December. According to STAT News, Pfizer and BioNTech are expected to be among the first manufacturers with a viable vaccine candidate. Pfizer during a Sept. 15 call said about 12,000 of its 30,000 volunteers had received the full regimen of the company's vaccine candidate, and the company now plans to expand its Phase 3 study to include 44,000 participants.

    The Times on Monday reported that the White House had rejected the new criteria in part because of the recommended two-month follow up period. FDA told Inside Health Policy on Tuesday that the guidelines had received White House approval. But, hours after FDA posted the new guidelines, President Trump in a tweet criticized the move, calling it a "political hit job!"

    FDA, former FDA officials stand by guidance

    FDA Chief Counsel Stacy Cline Amin during a press conference on Tuesday said the criteria have been in the works for a while and should not be a surprise to industry stakeholders.

    "For a vaccine, we are looking for an assurance of safety and a demonstration of efficacy that comes much closer to the [Biologic License Application] standard than what we have required for some therapeutics that are intended for very sick hospitalized patients," Amin said. "I'm not sure what could be surprising or alarming about that. FDA has not raised the bar for an EUA, as has been inaccurately reported."

    Politico on Monday had reported that the White House initially blocked the guidance after receiving push back from the pharmaceutical industry.

    However, former FDA Commissioner Scott Gottlieb, who now serves on the board at Pfizer, in a tweet Monday also said the guidance shouldn't come as a surprise to drugmakers, and he refuted claims that the pharmaceutical industry opposed the language.

    (Zimmer/Weiland, New York Times, 10/6; Branswell/Herper, STAT News, 10/6; Owens, "Vitals," Axios, 10/7; Wang, Inside Health Policy, 10/6 [subscription required]; New York Times, 10/7).

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