FDA Sets Goals That May Put Vaccine Out of Reach Before Vote

The U.S. Food and Drug Administration plans to have an expert panel review any Covid-19 vaccine application for emergency use, and wants to see at least two months of safety data, according to a document posted by the agency Tuesday.

The requirements will almost certainly add to the time it will take to review any vaccine, potentially past President Donald Trump’s goal of having one by Election Day next month. While the FDA has said it plans to work as quickly as possible, it has also said it won’t cut scientific corners or bend to political pressure to rush a vaccine.

Pfizer Inc.,Moderna Inc.,AstraZeneca Plc andJohnson & Johnson all have vaccine candidates in late-stage clinical trials. Drugmakers too have said that they intend to stick to the science and not bend to political demands to accelerate their development efforts.

Trump, whose re-election hinges on his response to the Covid-19 pandemic, has repeatedly suggested a vaccine will be ready by Nov. 3. The added steps will likely lengthen the process and make hitting Trump’s target unlikely.

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The two-month window “likely assures no Covid vaccine EUA consideration is possible until around November 24-25 for Pfizer/Moderna at the earliest,” Steven Seedhouse, a Raymond James analyst, said in a note to clients Tuesday.

Thedocument is the agency’s most detailed public statement yet on what it will take to get a vaccine cleared under a fast-track emergency use authorization, or EUA. The agency has been working on a separate “guidance” document that details the requirements, but itremains under review by the White House and it’s not clear when or if it will be released.

While the contents of the original guidance document are under review, the FDA has repeatedly said it has already shared the details with drugmakers. Publishing the requirements in the document released Tuesday essentially makes them public.

It also makes clear that the FDA will add an extra step. In Tuesday’s document, the FDA said it will require an additional, follow-up meeting of its Vaccine and Related Biological Products Advisory Committee to look at specific applications by drugmakers.

“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,” the FDA said in the document.

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Pfizer has indicated that it could have data showing its vaccine candidate is safe and effective as soon as this month, but there have been signs recruitment in its late-stage trial is slowing.

In a series of tweets, Pfizer Chief Executive Officer Albert Bourla said the drugmaker has “never discussed” the FDA’s vaccine guidelines with the White House and “will never do so as it could undermine the agency’s independence.”

@AlbertBourla

Pfizer has never discussed @US_FDA’s #COVID19 vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.5:41 PM · Oct 6, 2020

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Other trials are likely to read out later in the year. Moderna CEO Stephane Bancel said at a Financial Times conference last week that the company doesn’t expect to be able to file for an emergency authorization before the end of November. And a U.S. trial of AstraZeneca Plc’s experimental vaccine is still on hold after a trial participant in the U.K. was sickened.

The FDA documents were posted ahead of an Oct. 22 meeting by the VRBPAC to discuss generally how the agency will review a Covid-19 vaccine.

The agency had “already communicated with individual manufacturers about its expectations, data the agency intends to consider” and what it expects “to see in a request for an emergency use authorization to demonstrate safety and efficacy,” FDA spokesman Michael Felberbaum said in a statement Monday, after the New York Times and Politco reported Monday that the original guidance document had been blocked by the White House.

— With assistance by Cristin Flanagan

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