No new guidance, but here's some advice: FDA draws a line in the sand for Covid-19 vaccine developers
Less than a day after reports emerged that the White House cited industry opposition in a move to block stricter Covid-19 vaccine guidelines, the FDA is spelling out exactly what regulators have been communicating to developers looking for an emergency use authorization.
In doing so, the regulators are officially drawing a line in the sand amid an increasingly chaotic campaign to bring a vaccine to market at record speed.
In the briefing documents for the Vaccines and Related Biological Products Advisory Committee ahead of its Oct. 22, 2020 meeting, the agency tucked in two appendices. The first was a lengthy guidance from June, unedited, on development and licensure of a vaccine to prevent Covid-19. But the second — a document titled “Summary of Advice Provided to Individual Sponsors in Response to Questions Regarding Emergency Use Authorization of Vaccines to Prevent COVID-19” — is new to the public.
Per the 5-page summary, the FDA has suggested to sponsors that their EUA requests should meet a higher bar than what’s outlined in the guidance. These additional safety and efficacy requirements match the stricter standards that the FDA was about to publish before the White House overruled them.
Assuming companies follow the advice (and CBER chief Peter Marks has emphasized that they “knew what we’re expecting”), it would be all but impossible for any vaccine developer to submit an up-to-par application before Election Day, let alone get cleared for EUA as President Donald Trump has promised.
For instance, the FDA said it’s told sponsors to report data with a median follow-up of at least two months after “completion of the full vaccination regimen” to monitor adverse events; safety numbers on “well over 3,000 vaccine recipients”; and “a total of 5 or more” severe Covid-19 cases in the placebo group to assuage concerns about vaccine-induced enhanced respiratory disease.
Then there’s the advice for companies to provide a detailed description of their manufacturing process and controls no less than one month prior to seeking an EUA. That means for an EUA to be issued by Nov. 3, a company would have submitted this information days ago.
Each of these submissions, the FDA added, will be scrutinized individually by the same panel of outside experts it has convened in two weeks:
FDA expects to convene an open session of FDA’s VRBPAC prior to the issuance of any EUA for a COVID-19 vaccine, to discuss whether the available safety and effectiveness data support authorization of an EUA for the specific request under review. This discussion will be specific to the particular vaccine that is the subject of the EUA request and will be separate from, and in addition to, any general discussion by the VRBPAC regarding the development, authorization and/or licensure of vaccines to prevent COVID-19.
Oct. 22, though, will be when the general discussion happens. Regulators have asked the adcomm to explore what additional studies vaccine developers should conduct, either before or after an OK, to evaluate their candidates. Should they be doing trials in children and pregnant women? Is there a need for post-marketing safety studies following a full BLA approval? What about post-EUA safety follow-up?
Pfizer/BioNTech, Moderna, AstraZeneca/Oxford, J&J and a slate of others will surely be tuning in.
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