There appears to be growing tension between the Biden administration and at least some people affiliated with public health agencies over recommending covid-19 booster shots for all next month. Two senior officials with the Food and Drug Administration are leaving, reportedly in part due to the White House’s decision to promise boosters to the public without first clearing it with the FDA. Meanwhile, some outside advisory members with the CDC have recently signaled that they favor a slower rollout to boosters, possibly recommended only for those most vulnerable at this time.
Earlier today, the FDA confirmed that Marion Gruber and Phil Krause would leave the agency within the next two months. Both are long-time officials that have played an important role in the rollout of many vaccines, including the three covid-19 vaccines authorized and approved in the U.S. Gruber is currently the head of the FDA’s Office of Vaccines Research and Review, and has worked at the FDA for 32 years, while Krause is a deputy director there, with over 10 years of FDA experience.
Former FDA officials praised the two for their years of service, as did Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a letter sent to staff and obtained by BioPharma Dive. But these departures may not have entirely been on good terms. Citing discussions with a former senior FDA official, Endpoints News reported that the men have felt frustrated for some time about the decision-making process involving the covid-19 vaccines.
Much of this reported angst had to do with the CDC and its advisory committee of outside experts making decisions that they felt should be left to the FDA. But the apparent final straw was when the White House announced last month that it would sanction boosters for the general public by September 20. The joint statement announcing this move was signed by various head officials, including at the FDA and CDC, but noted that it would only be official once the FDA and CDC formally signed off on it.
Part of this process will include deliberation by the CDC’s Advisory Committee on Immunization Practices (ACIP), whose guidelines affect the scheduling and administration of vaccines authorized or approved by the FDA. On Monday afternoon, the ACIP met to discuss and unanimously recommend the use of the now-approved Pfizer/BioNTech vaccine for ages 16 and up. But they also briefly discussed the issue of booster shots, with some expressing more skepticism of their necessity right now than the White House has.
There is general agreement that a booster dose will at least temporarily reduce the risk of any infection—and presumably transmission—for the vaccinated, but the debate about whether these shots are needed currently to keep people safe from hospitalization and death is ongoing. Some at the ACIP meeting argued that much greater focus should be paid to getting unvaccinated people their first shots, rather than approving boosters at this time, given how well it protects against serious illness and death.
“We’ve got lots of vaccine. At the moment, we don’t have a lot of evidence of reduced vaccine effectiveness,” said ACIP committee member Beth Bell, a doctor and clinical professor of global health at the University of Washington in Seattle.
Others argued that the U.S. can work hard to vaccinate the unexposed, while also still ensuring that boosters are provided to the groups most vulnerable to serious illness from the pandemic, namely older people. Last month, the ACIP approved a third dose of the mRNA vaccines for immunocompromised people, not as a booster but as part of the standard schedule moving forward, given evidence that these individuals produce a weaker immune response to vaccination.
Israel is the country that’s gotten furthest ahead in offering boosters to its citizens. Early data from there does suggest that the booster can restore some level of protection against infection from the coronavirus, as well as possibly reduce the risk of serious illness that seemed to increase in the first residents who were vaccinated late last year. But other scientists have questioned whether Israel’s data has really shown a significant drop in vaccine effectiveness against serious illness, as their officials claim. Most data from elsewhere, including in the U.S., has found that protection against the worst outcomes remains very high, even with the Delta variant around.
There are expected to be additional meetings by the ACIP to debate the approval of boosters for the general public, though no formal date has been announced; the FDA and its advisory committee are expected to meet in September as well.