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September 1, 2020

As coronavirus vaccine approval nears, is FDA's credibility at risk?

Daily Briefing

    FDA Commissioner Stephen Hahn said the agency could authorize use of a coronavirus vaccine candidate before phase three clinical trials are completed—a statement that comes amid controversy over whether some of the agency's recent moves have been influenced by political pressure.

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    Hahn says FDA could fast-track authorization of coronavirus vaccine

    During a recent interview with the Financial Times, Hahn said FDA could issue an emergency use authorization (EUA) for a coronavirus vaccine candidate without complete results from phase three clinical trials.

    "It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," he said. "If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate; we will make a determination."

    Hahn noted that EUAs are "not the same as a full approval," adding, "The legal, medical, and scientific standard for [an EUA] is that the benefit outweighs the risk in a public health emergency."

    Hahn said FDA will not succumb to any political pressure to quickly authorize use of a coronavirus vaccine.

    "We have a convergence of the Covid-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles," Hahn said. He continued, "This is going to be a science, medicine, data decision. This is not going to be a political decision."

    FDA has faced criticism for recent emergency authorizations

    Hahn's announcement comes amid scrutiny of some of FDA's moves in the coronavirus epidemic to date, many of which have occurred under intense political pressure.

    Early in the epidemic, FDA issued an EUA for hydroxychloroquine after President Trump touted the drug as a possible Covid-19 treatment—only to revoke the EUA two months later after data suggested the drug's benefits did not outweigh its risks.

    More recently, FDA issued a controversial EUA that allows providers to use convalescent plasma to treat patients hospitalized with Covid-19. Just days earlier, media outlets had reported that leading federal health officials had halted the authorization because existing data hadn't demonstrated whether the treatment was effective. After that news broke, Trump in a tweet wrote, "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the [coronavirus] vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd."

    Days later, FDA issued the EUA for convalescent plasma. Hahn later acknowledged in a tweet that he had misstated evidence in favor of convalescent plasma in his public remarks supporting the EUA.

    Is FDA 'tainted'?

    Some experts have said the events make it seem as if FDA is moving more quickly than it typically would on experimental coronavirus treatments because of political pressure.

    "Given the premature authorization of hydroxychloroquine and convalescent plasma, the FDA is perceived by many as tainted," Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital, said.

    Public opinion appears to reflect similar concerns. A recent poll conducted by STAT News and the Harris Poll found that 78% of respondents said they were worried the approval process for a coronavirus vaccine is being driven more by politics than science, STAT News' "Pharmalot" reports.

    In light of these concerns, the American Medical Association (AMA) has urged FDA to develop new processes to ensure transparency about vaccine developments.

    "We need to see light," AMA President Susan Bailey said. "There is a concern that if you are not seeing the data, you have to wonder why."

    Similarly, a group of prominent physicians and health experts called on FDA to create an independent commission to review trial data on coronavirus vaccine candidates before the agency authorizes one for use.

    "We're used to this world where if the FDA or the CDC or the [National Academy of Sciences] says something is safe and effective, that's enough, but I don't think this time that's sufficient to overturn public skepticism," Arthur Caplan, a bioethicist and director of medical ethics at NYU Langone Health, said. "I think we desperately need an independent national commission."

    Other experts, however, have expressed confidence in FDA's process for authorizing a coronavirus vaccine.

    For instance, former FDA Commissioner Scott Gottlieb during an appearance on CBS' "Face the Nation" said he was confident the agency will wait for sufficient data before approving a vaccine candidate.

    "I'm not sure what [Hahn] means by approving [a vaccine] earlier than when the trials are completed," Gottlieb said, but he explained that phase three clinical trials sometimes can produce actionable data before the studies end. "These phase three trials are event-based trials, meaning that they're going to start to read out data after a certain amount of events accrue in the clinical trials. And those events are people getting [coronavirus] infection. And so as the trials progress, [we could] start to see lower rates of [coronavirus] infection in the active group, the group that receives the vaccine versus the placebo group, the group that hasn't received the vaccine," he noted.

    Gottlieb said, "They are going to wait for these trials to read out before they can make a decision around the efficacy of these vaccines," and he added that the trials could provide actionable data in October if the vaccine candidates are "very effective."

    How FDA is addressing concerns about political pressure

    For his part, Hahn during his interview with the Financial Times said FDA will share as much data on potential coronavirus vaccines as possible.

    "We are committed to being transparent because we realize this is very important to the American people," Hahn said.

    Further, a mid-August blog post in Health Affairs written by Hahn and two physicians at FDA—Anad Shah and Peter Marks—detailed the steps FDA will take to "offer reassurance that any potential vaccine will be safe and effective."

    "First, the agency established clear recommendations for vaccine performance prior to the initiation of Phase 3 trials to provide assurance that any authorized vaccine will meet appropriate standards for safety and effectiveness," the blog post stated.

    "Second, FDA has committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public," the post continued (Perrone/Alonso-Zaldivar, AP/ABC News, 8/28; Silverman, "Pharmalot," STAT News, 8/31; O'Brien, CNBC, 8/30; Armstrong, Bloomberg, 8/30; Cohen, CNN, 8/31; Klar, The Hill, 8/30).

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