FDA has told coronavirus vaccine developers that it will hold them to strict standards for emergency authorization, even though the White House has so far blocked the formal release of the requirements.
The agency disclosed its actions in documents released Tuesday ahead of a scheduled Oct. 22 meeting of an FDA advisory committee on coronavirus vaccines.
FDA said it had advised vaccine developers that they must monitor half of clinical trial participants for at least two months following their final dose of vaccine or placebo before applying for emergency authorization. FDA has also told vaccine developers that they should wait to apply until at least five severe cases of Covid-19 have been reported among trial participants receiving the placebo.
Those requirements — which mimic the guidance document that the White House has so far quashed — are designed to ensure that there is adequate safety data on any vaccine before it is authorized for emergency use, FDA said. POLITICO reported yesterday that the White House had blocked the release of the standards after officials close to President Donald Trump told him that the pharmaceutical industry objected to FDA's stance.
FDA's decision to hold vaccine developers to the stricter criteria, which go beyond initial guidance the agency released in June, will likely push any vaccine authorization beyond Election Day. Trump has repeatedly promised to deliver a vaccine before then, contradicting predictions of top federal health officials.
Background: The news that the FDA is plowing ahead with the stricter standards comes after almost a month of back and forth between the White House and the agency over how to set the bar for vaccine authorization.
Several companies with vaccines in late-stage trials have said they will not seek authorization before the election. But Pfizer CEO Albert Bourla has repeatedly said the company could have a vaccine ready for review this month.
What's next: The FDA's coronavirus vaccine advisory committee will meet on Oct. 22, but is not scheduled to address any of the individual vaccines in late-stage trials.
Instead, the committee will discuss the legal requirements for authorizing a vaccine and other FDA guidance on vaccine approvals released last June. The agency also says it will hold more committee meetings of outside experts before each vaccine obtains an emergency use authorization or a full approval.