Clashes between White House and CDC and FDA experts over Covid-19 booster shots

There appears to be growing tension between the Biden administration and at least some people affiliated with public health agencies over the recommendation. covid-19 booster injections for all next month. Two senior Food and Drug Administration officials are leaving, apparently in part because of the White House’s decision to promise boosters to the public without first clearing it to the FDA. Meanwhile, some external advisory members with the CDC recently signaled that they were in favor of a slower rollout of boosters, perhaps only recommended for the most vulnerable at this time.

Earlier today, the FDA confirmed that Marion Gruber and Phil Krause will be leaving the agency within the next two months. Both are longtime government officials who have been instrumental in the deployment of many vaccines, including the three covid-19 vaccines licensed and approved in the United States. Gruber is currently the head of the FDA’s Office of Vaccine Research and Review, and worked at the FDA for 32 years, while Krause is Deputy Director there, with over 10 years of experience at the FDA.

Former FDA officials commended 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 to staff and got by BioPharma Dive. But these departures may not have been entirely on good terms. Citing discussions with a former senior FDA official, Endpoints News reported that men have felt frustrated for some time with decision-making process involving covid-19 vaccines.

Much of this reported angst had to do with the CDC and its advisory panel of external experts making decisions they believed should be left to the FDA. But the apparent final drop was when the White House announcement last month that he would sanction boosters for the general public by September 20. declaration The announcement of the decision was signed off by various officials, including the FDA and CDC, but noted that it would not be official until the FDA and CDC officially approved it.

Part of this process will include the deliberations of the CDC Advisory Committee on Immunization Practices (ACIP), whose guidelines affect the scheduling and administration of vaccines authorized or approved by the FDA. Monday afternoon, ACIP meet to discuss and unanimously recommend the use of the Pfizer / BioNTech vaccine now approved for ages 16 and over. But they also briefly discussed the issue of booster shots, with some expressing more skepticism about their need at this time than the White House has.

It is generally accepted that a booster dose will at least temporarily reduce the risk of infection—and probably the transmission–for the vaccinated, but the debate on whether these injections are currently needed to protect people from hospitalization and death is occurring. Some participants in the ACIP meeting argued that much more attention needs to be paid to getting unvaccinated people vaccinated for the first time, rather than approving boosters for now, given the quality of the vaccine. their protection. against serious illness and death.

“We have a lot of vaccines. At present, we don’t have much evidence of reduced vaccine efficacy, ”said Beth Bell, ACIP committee member, physician and clinical professor of global health at the University of Washington in Seattle.

Others have argued that the United States can work hard to vaccinate those who are unexposed, while ensuring that reminders are provided to groups most vulnerable to serious illnesses from the pandemic, namely the elderly. Last month, ACIP approved a third dose of mRNA vaccines for immunocompromised people, not as a booster but as part of the standard schedule going forward, as these people produce a weaker immune response. vaccination.

Israel is the country that has advanced the most in offering boosters to its citizens. The first data from there suggests that the booster can restore a certain level of protection against coronavirus infection, as well as possibly reducing the risk of serious illness this appeared to be increasing in the early residents who were vaccinated late last year. But other scientists have interrogates whether Israel’s data really showed a significant drop in the effectiveness of vaccines against serious illnesses, as their officials claim. Most data from elsewhere, including the United States, has find this protection against the worst results remains very high, even with the Delta variant.

There are expected to be additional ACIP meetings to discuss the approval of boosters for the general public, although no formal date has been announced; the FDA and its advisory committee are also scheduled to meet in September.