Trump Says White House Could Reject Stricter COVID-19 Vaccine Requirements

In a stunning departure from how FDA guidances are issued by the agency, President Donald Trump said Wednesday evening that he might move to reject a guidance that is expected to impose stricter thresholds for any COVID-19 vaccine Emergency Use Authorizations (EUAs).

“We’re looking at [the guidance], and that has to be approved by the White House,” the president said during a press briefing. “We may or may not approve it. I think [it] was a political move more than anything else.”

It would likely be the first time that the White House has gotten so directly involved with the issuance of an agency guidance. The guidance could come as soon as this week and it’s expected to require vaccine manufacturers pursuing an EUA to track phase 3 trial participants for at least two months and to include at least five severe COVID-19 cases and some cases in older patients in a trial’s placebo group (DID, Sept. 23).

The president’s move to directly involve the White House in the FDA’s guidelines for EUAs is likely to be met with widespread criticism even as the president himself accuses the agency of politically interfering with the approval of a COVID vaccine.

The president has repeatedly expressed optimism that a vaccine will be delivered before the election, perhaps as soon as October, he has said, leading to accusations from more than a few former FDA officials and other leading public health officials that he is politically strong-arming the agency to rush an authorization or approval to help his reelection prospects.

The president has previously accused the FDA of political bias, while the agency has been equally adamant in its denials of alleged bias. FDA Commissioner Stephen Hahn has publicly offered reassurance that the agency would be led only by science in its decisions on COVID-19 vaccines and treatments and has vowed that he would resign rather than be forced to rush through a vaccine approval.

To date, four COVID-19 vaccines have entered late-stage trials in the U.S. Trump expressed that he has “tremendous confidence” in the companies conducting the studies and argued that the new guidance with its stricter thresholds — aimed at assuring a skeptical public that agency decisions are being directed by science and data — would only delay approval. — Jordan Williams and James Miessler