President Donald Trump noted that he could veto any tightening of US rules for emergency authorization of a coronavirus vaccine, a move that could heighten concerns that the race to find a Covid-19 injection will be over. is politicizing before the presidential elections.
The Food and Drug Administration is expected to issue final guidelines for an emergency use authorization soon. Regulators and drug manufacturers have vowed in recent weeks to adhere to science, not politics, when deciding when a vaccine is ready to hit the market.
At a news conference Wednesday, Trump said it “sounds like a political move” when asked if the FDA was considering stricter standards for an authorization, suggesting that the White House might intercede if it thought the agency was too rigorous.
“That has to be approved by the White House,” Trump said. “We can approve it or not.”
A representative for the FDA declined to comment.
If a vaccine shows promising early signs of being safe and effective, it could be allowed to hit the market urgently before the full results of a clinical trial are available. Companies like Pfizer Inc., Moderna Inc., AstraZeneca Plc, and Johnson & Johnson have vaccine candidates in late-stage clinical trials. Some of those studies could produce efficacy data starting in October.
Trump is trailing Democrat Joe Biden in polls leading up to the November election, and polls show that a majority of Americans disapprove of the president’s handling of the virus. Trump has tried to focus on other issues while claiming that his administration is doing a good job handling the virus.
The president has promised that a coronavirus vaccine will be approved in a few weeks, a tactic to turn a pandemic vaccine into an October surprise for his re-election fight.
Trump and his supporters have also questioned whether government employees are trying to sabotage their efforts to fight the virus. In August, the president attacked the FDA for harboring “deep state” personnel who slowed work on vaccines and drugs to harm it politically. There is no evidence that this is the case.
FDA officials have indicated that they would maintain a vaccine to a higher standard than other drugs that generally receive emergency exemptions from the agency.
Peter Marks, director of the agency’s biologics office, described earlier this month what he called a US-plus program that would speed up the review of a vaccine, but requires data standards similar to those used when the FDA is considering full approval.
Marks also said at the time that the FDA would like companies to have a median of two months of follow-up of trial participants after receiving the vaccine.
“That’s what we hope for,” Marks said. “Most adverse events will occur about a month and a half after vaccination.”
He also said that any plan for an emergency authorization would include longer-term follow-up once the vaccine is on the market.
The FDA has been trying to rebuild trust as Trump publicly lobbies for a vaccine to be authorized for the November 3 election. FDA Commissioner Stephen Hahn has been criticized for overstating the benefit of a plasma treatment that the agency authorized for use against the virus last month. Hahn has tweeted multiple times since outside FDA advisers would review the vaccine data.
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