FDA’S internal turmoil could impact COVID-19 boosters, shots for kids
WASHINGTON — Signs of internal turmoil at the Food and Drug Administration are raising concerns among former agency officials as widely anticipated deadlines on COVID-19 boosters and vaccines for children near.
A high-stakes debate about whether the booster shots are necessary recently led to upheaval at the FDA’S Office of Vaccines Research and Review, namely the sudden sidelining of that office’s two most experienced regulators.
The drama comes amid a critical month for U.S. vaccine policymaking. FDA documents on CO
VID-19 boosters for Moderna and Johnson & Johnson recipients are expected to become public ahead of meetings of the FDA’S independent advisers on vaccines next week.
Other FDA briefing documents on vaccines in children 5 to 11 years old are expected before the independent advisers meet again on Oct. 26. Many parents hope the advisers and then FDA will greenlight shots for kids just before Halloween.
Former FDA officials say the departure of top vaccine reviewers who were with the agency for decades could impair important analysis of the data.
The chaos in the vaccines office also underscores the fact that, nine months into the Biden administration, the FDA lacks a permanent leader. The White House has yet to nominate a commissioner. Acting Commissioner Janet Woodcock, a longtime career official, has temporarily led the FDA since January.
“There are strong reasons we don’t just go by a company’s press release or a paper in a journal. There were times when I was at FDA that we would have different conclusions than even the best medical journal,” said Jesse Goodman, a Georgetown University biotech policy expert and former FDA chief scientist. “When it comes to something that turns from the conclusion of a scientific paper to public health policy for the whole United States in the space of a few weeks, that’s when we need to be really careful to get it right.”
Goodman criticized Woodcock for signing off on an announcement by President Joe Biden recommending booster shots for every American by the week of Sept. 20, a recommendation that put pressure on the FDA and appears to have been premature.
“It’s important not just to have a permanent commissioner but also a permanent commissioner who understands the importance of these scientific agencies,” he said. Dispute over boosters Tensions rose when the FDA’S top vaccine reviewers, Office of Vaccines Research and Review Director Marion Gruber and Deputy Director Phil Krause, opposed the push to broadly offer third shots.
Their boss, Center for Biologics Evaluation and Research Director Peter Marks, supported the White House’s booster plan, but Gruber and Krause said immunity from two shots is durable for most people and that extra doses should be donated abroad. Gruber and Krause publicly announced their views in The Lancet and said they would retire later this year.
But last week, Marks, whose background is in cancer drugs, announced he would take over the vaccines office. The announcement came as a surprise, given that Gruber and Krause had previously announced they would stay on longer.
The departures of Gruber and Krause will result in four vacancies among the 31 leadership positions in the vaccines office listed on the CBER website.
“Peter Marks is not a vaccine expert,” said Norman Baylor, president of Biologics Consulting Group and former director of the FDA’S vaccines office. “He doesn’t have the years of regulating vaccines or understanding vaccinology like Phil and Marion.”
While directors of the vaccines office do not conduct hands-on reviews, they smooth out differences in interpretation among lower-ranking reviewers and resolve complex questions.
“If you’re a reviewer and you have a question, you have someone to huddle with who’s been in the trenches much longer on this subject matter. So it’s going to have an impact,” W continued.