FDA Says It Told Vaccine Makers of Principles for Emergency Use

(Bloomberg) -- The Food and Drug Administration said it's made clear to drugmakers the standards for a vaccine to be cleared for emergency use, obviating a more formal FDA guidance document that is still under review by the White House.

As final-stage trials of Covid-19 vaccines proceed, the FDA has worked to make clear what standards would have to be met to authorize use of the shots. One such path is an emergency-use authorization, or EUA, a fast-track procedure that relies on less safety and efficacy data than a full approval.

On Monday, the New York Times and Politico both reported that the EUA guidance had been blocked by the White House.

An FDA spokesman also said the EUA guidance was still under review, and that drugmakers working on vaccines had already been informed by the agency what the standards would be -- despite the lack of publication of the document.

“This does not change how the FDA would evaluate an emergency use authorization request for a Covid-19 vaccine,” said Michael Felberbaum, an agency spokesman. “The FDA has already communicated with individual manufacturers about its expectations, data the agency intends to consider, and what we expect to see in a request for an emergency use authorization to demonstrate safety and efficacy.”

Earlier: FDA Official Says Vaccine Makers Know Data Agency Expects

Peter Marks, director of the FDA's biologics office, said at a Sept. 29 event that that includes at least two months of data on the safety of any Covid-19 vaccine. The guidance document, Marks said at the time, “was an attempt to help the public see what we were requiring of Covid vaccines so they understood.”

As President Donald Trump has made repeated assertions that a vaccine would be ready by Election Day, and accused “deep state” staff in the agency of working against him, the FDA's leadership has sought to reassure the public that any vaccine it reviews won't be influenced by political considerations.

Politico, in its report Monday, said that lobbying by the drug industry to the White House had been behind the blocking of the guidance.

The FDA isn't aware of any such effort or pressure, an adminstration official said Monday night. A senior administration official disputed the Politico report and said there had been no industry pressure.

“Science will guide our decisions,” FDA Commissioner Stephen Hahn said in an Oct. 1 tweet. “FDA will not permit any pressure, from anybody, to change that.”

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