FDA asking COVID-19 vaccine developers for two months of safety data, raising doubts about approval by Election Day

The Food and Drug Administration (FDA) wants coronavirus vaccine developers to submit two months of safety data before applying for emergency approval, circumventing the White House, which has expressed concerns about the stringent requirements.

The FDA, in documents posted online Tuesday, advised drugmakers conducting COVID-19 vaccine clinical trials to monitor patients for at least two months to assess potential negative effects from their candidates.

President Trump has recently called those steps a “political move” that would surely mean a vaccine is not approved by Election Day.

The White House blocked the FDA from issuing a formal release of the guidance, with The New York Times reporting Monday that chief of staff Mark Meadows had questioned the need for two months of safety data. Meadows also suggested that FDA Commissioner Stephen Hahn, a Trump appointee, was overly influenced by the agency’s career scientists, the Times reported.

The FDA shared the guidelines anyway through briefing materials to its vaccine advisory committee, instead of through formal guidance that would need approval from the White House. After the FDA published those materials, the guidance was also put alone. 

There are several COVID-19 vaccine candidates in the third stage of clinical trials, which seek to determine the safety and effectiveness of a vaccine.

While Trump has repeatedly speculated that a vaccine could be ready by Election Day, experts contend that is highly unlikely.

Monitoring participants in clinical trials for two months after their final vaccine doses would likely push any potential FDA approval past Nov. 3.

Experts, including former FDA commissioners, have expressed concerns that Trump is undermining public confidence in the vaccine approval process by making timeline predictions and attacking career officials at the agency.

In August, Trump accused “deep state” officials at the FDA of deliberately stalling the approval of a COVID-19 vaccine to hurt him.

To boost public confidence in the process, nine pharmaceutical companies working on COVID-19 vaccines issued a rare joint pledge in September not to seek FDA approval until a rigorous phase three clinical trial shows it is safe and effective.

Albert Bourla, chairman and CEO of Pfizer, tweeted Tuesday that the company had “never discussed” the FDA’s vaccine guidelines with the White House and “will never do so as it could undermine the agency’s independence.”

“FDA’s public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment,” Bourla said. “In fact, we believe FDA’s independence is today more important than ever as public trust in COVID 19 vaccine development has been eroded by the politicization of the process.”