FDA Commissioner Stephen Hahn, M.D., has defended the pace of the review of Pfizer’s COVID-19 vaccine on the grounds that a thorough assessment is needed to reassure a skeptical public.
Hahn, speaking to The Wall Street Journal, made the comments in the wake of the authorization of the vaccine for use in the U.K. President Donald Trump’s chief of staff reportedly demanded to know why the British were moving faster. Hahn declined to comment on that interaction with the White House in his conversation with the WSJ but did set out how the FDA is approaching the process and why.
“We realize there is an issue in the U.S. around vaccine hesitancy. There have been concerns raised about the speed with which COVID-19 vaccines have been developed,” Hahn said. “This will meet our gold standard of safety and efficacy that the American people have come to trust.”
A Gallup poll conducted in late October found 42% of Americans would refuse to take a FDA-approved COVID-19 vaccine. In an earlier poll, conducted in September, half of Americans said they would refuse the vaccine. The data suggest public health officials face a struggle to get people to buy into a mass vaccination campaign.
Hahn cited that risk to explain the FDA’s approach. Pfizer filed for approval Nov. 20 but is unlikely to win FDA approval until after Dec. 10, when the agency is holding an advisory committee meeting to discuss the submission. Hahn said to expect a decision within four days of the meeting.
Between now and then, the FDA needs to prepare the briefing documents to inform the meeting. The efficacy of Pfizer’s vaccine in a disease that is having a major impact on the U.S. means it would be a major surprise if the advisory committee voted against the candidate. Hahn said the FDA “felt it was important to have that independent body take a look at it,” though.
Hahn outlined how the FDA is trying to truncate its review timeline, which is typically six months for a fast-tracked application, without compromising on the thoroughness of the process. The FDA has 150 people working long hours in parallel teams to assess the data submitted by Pfizer. Through the process, the FDA is probing questions such as the effect of age and ethnicity on outcomes.
The FDA’s approach, and thinking behind it, is in line with that of the EU. With the U.K. claiming its fast clearance as a win for Brexit, despite the authorization happening under an EU law, officials across the English Channel defended their approach. German Health Minister Jens Spahn struck a similar tone to Hahn, stating it is important to go through a longer process “to help promote trust and confidence in this authorization.”