- The man in charge of the Trump administration’s efforts to aid the development of coronavirus vaccines told Business Insider he supports a decision to require two months of safety data before approving any COVID-19 vaccine.
- “I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the scientific head of Operation Warp Speed, said in a Tuesday morning phone interview. “It’s very important.”
- That requirement will almost certainly prevent a vaccine from gaining emergency approval before the presidential election on November 3.
- The agency spelled out its requirements Tuesday by releasing guidance for industry. Top White House officials reportedly opposed that guidance.
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In the race to develop a coronavirus vaccine, US regulators just laid down guidelines that make it difficult, if not impossible, for any COVID-19 shot to win emergency approval before Election Day.
The US Food and Drug Administration is asking vaccine developers to submit at least two months of safety data as part of an emergency-approval application, according to documents released Tuesday. The White House reportedly opposed that measure, with President Donald Trump saying on September 23 it “sounds like a political move.”
Despite pushback from the administration, the FDA publicly released those guidelines on Tuesday. And the man leading the US government’s efforts to help develop a vaccine said he supports the FDA.
“I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the chief advisor to Operation Warp Speed, told Business Insider in a Tuesday phone interview. “It’s very important.” Business Insider asked