FDA Releases COVID-19 Vaccine Guidelines Despite Trump Opposition

New York Daily News

The U.S. Food and Drug Administration wants coronavirus vaccine developers to follow trial patients for at least two months before seeking emergency approval, according to a newly released set of guidelines that the Trump administration is trying to block.

The proposed requirements, posted online Tuesday morning, would almost certainly prevent the White House from authorizing a vaccine before Election Day, potentially dealing a blow to President Trump’s attempt to score a last-minute political victory before voters head to the polls.

The two-month review would come after the “full vaccination regime” is complete to “help provide adequate information” about the vaccine trial and rule out potential safety issues, FDA officials wrote.

The guidelines also call for at least five cases of severe COVID-19 infections in a trial’s placebo group to ensure a vaccine is effective against those with more serious symptoms.

The agency released its proposed standards just hours after the New York Times confirmed that White House officials had intervened to block the new guidelines. In an apparent sign of defiance, the agency shared the information anyway as part of a briefing document for an Oct. 22 advisory committee meeting.

FDA officials said they recognize “the urgency of developing a vaccine” against coronavirus and have discussed the standards with drug manufacturers throughout the process.

“To help expedite the development and availability of safe and effective COVID-19 vaccines, FDA has been working closely with vaccine developers by providing timely regulatory advice regarding data needed to demonstrate the safety and effectiveness of COVID-19 vaccines,” the agency said in the document.

Pfizer is the only manufacturer to publicly suggest it could have data on the safety and effectiveness of a vaccine before Nov. 3. But the company has vowed not to “succumb to political pressure."

“The only pressure we feel -- and it weighs heavy -- are the billions of people, millions of businesses and hundreds of government officials that are depending on us,” Pfizer CEO Albert Bourla said in an open letter to employees.

Other drugmakers working on a vaccine include AstraZeneca, Johnson & Johnson and Moderna.

Globally, more than 180 experimental vaccines are under development to fight against COVID-19 -- which has killed at least 210,000 people in the U.S. and more than a million worldwide.

The Trump administration’s rush to approve a vaccine for the virus has raised concerns about the safety of the process, with critics denouncing the move as a desperate and irresponsible attempt to put politics ahead of science.

“All new FDA guidance should be finalized and communicated with those on the frontlines developing potential vaccines,” the biotech industry’s trade association pleaded last week in a letter obtained by the Times.

“Just as importantly, it must also be shared more broadly with the American public. We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” the group told Trump’s health secretary, Alex Azar.