An FDA proposal aimed at tightening restrictions of a coronavirus vaccine emergency use approval has reportedly died on the desk of President Trump’s chief of staff.
According to a New York Times report, the new measures would have required that pharma manufacturers follow participants for a median of two months following their last vaccine dose — a timeline that would have certainly moved the opportunity for an EUA to after the Nov. 3 election. Forbes reported that the FDA also wanted drug developers to include five severe coronavirus patients and a sampling of older patients in the placebo group to help solidify the vaccine’s efficacy.
FDA officials reportedly felt that the tougher rules would help bolster confidence in the safety and efficacy of the new vaccines as polls show that Americans are becoming increasingly hesitant to take them.
But several White House insiders told Politico that the administration blocked the new measures over pharma industry objections. Trump also said in a Sept. 23 press conference that the new restrictions were “a political move more than anything else” and had threatened to reject them. Yet, Trump has also repeatedly teased the possibility of seeing a vaccine approved before the elections, raising concerns that the approval could be politicized.
At the moment, there’s only one company — Pfizer — that is targeting an application submission date before the Nov. 3 election.