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Bloomberg – FDA Official Says Vaccine Makers Know What Data the Agency Expects

Bloomberg – FDA Official Says Vaccine Makers Know What Data the Agency Expects

The head of the Food and Drug Administration office that oversees vaccines said drugmakers developing Covid-19 shots are aware of the data that will be required to gain an emergency-use authorization, regardless of whether the agency provides formal guidance.

“There’s no there there about this guidance to get excited,” said Peter Marks, director of the FDA’s biologics office, at a Friends of Cancer Research event Tuesday. “The companies know what we’re expecting.”

The FDA has been expected to publicly outline its standards for allowing a coronavirus vaccine to be used on an emergency basis. However, the guidelines have become a subject of political controversy, with President Donald Trump recently saying he could overrule anything he sees as too onerous.

Marks said Tuesday that the guidance “was an attempt to help the public see what we were requiring of Covid vaccines so they understood.”

Earlier this month, Marks said that the guidance would come out soon. He also said at the time that the FDA wants drugmakers to submit two months of follow-up data on how clinical-trial participants are faring after they receive a shot.

Marks said Tuesday that regulators needed to balance the need to make sure that a vaccine is safe with efforts to get the virus under control. “The bottom line is we’re going to do our job to make sure that we do the right benefit-risk calculation,” he said.

Marks said any vaccine authorization will require “clear and compelling” evidence of efficacy.…