There appears to be growing tension between the Biden administration and at least some people affiliated with public health agencies on recommendation reinforcement strokes covid-19 for all next month. Two senior Food and Drug Administration officials are reportedly leaving, in part because of the White House’s decision to promise boosters to the public without prior approval from the FDA. Meanwhile, some external advisory members recently with CDC have noted that they favor a slower deployment of drivers, possibly recommended only for the most vulnerable at this time.
Earlier today, the FDA confirmed that Marion Gruber and Phil Krause would leave the agency in the next two months. Both are long-serving officials who have played an important role in the deployment of many vaccines, including the three covid-19 vaccines authorized and approved in the US. Gruber is currently the head of the FDA’s Vaccine Research Office He reviews and has worked at the FDA for 32 years, while Krause is deputy director there, with more than 10 years of FDA experience.
Former FDA officials congratulated the two on their years of service, as well as Peter Marks, director of the FDA’s Center for Biological Product Evaluation and Research, in a letter sent to staff and obtained for BioPharma Dive. But these outings may not have been in good condition at all. Citing discussions with a former senior FDA official, Endpoints News reported that men have been frustrated for some time by decision-making process that includes covid-19 vaccines.
Much of this reported distress had to do with the CDC and its external expert advisory committee making decisions they felt should be left to the FDA. But the final appearance was when the White House announced last month that would sanction promoters for the general public on September 20th statement announcing this move was signed by several top officials, including the FDA and CDC, but noted that it would only be official when the FDA and CDC formally signed it.
Part of this process will include the deliberation of the CDC Advisory Committee on Immunization Practices (ACIP), whose guidelines affect the programming and administration of vaccines authorized or approved by the FDA. Monday afternoon, the ACIP met discuss and unanimously recommend the use of the Pfizer / BioNTech vaccine already approved for over 16s. But they also briefly discussed the issue of reinforcements, with some expressing more skepticism about their need at the time than the White House.
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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 over whether these traits are currently needed to protect people from hospitalization and continued death. Some at the ACIP meeting argued that much more attention should be paid to getting people who were not vaccinated to receive the first shots, rather than approving reinforcers at this time, given the degree of protection against serious illness and death.
“We have a lot of vaccines. Right Now, we don’t have much evidence of a reduction in vaccine efficacy, ”said Beth Bell, ACIP committee member, doctor and clinical professor of global health at the University of Washington in Seattle.
Others argued that the United States can work hard to vaccinate those who are not exposed, while also ensuring that boosters are provided to the groups most vulnerable to serious pandemic diseases, that is, the elderly. Last month, ACIP approved a third dose of mRNA vaccines for immunocompromised individuals, not as a booster but as part of the advanced standard schedule, given evidence that these individuals produce a weaker immune response to vaccination.
Israel is the country that has made the most progress in offering drivers to its citizens. Early data from there suggest that reinforcement may restore some level of protection against coronavirus infection, as well as possibly reducing the risk of suffering serious illness this appeared to increase in the first residents vaccinated late last year. But other scientists do questioned whether Israeli data have really shown a significant decrease in the effectiveness of the vaccine against serious diseases, as its officials claim. Most data from other places, including the United States, have it Found that protection against the worst results remains very high, even with the Delta variant around.
There are expected be additional meetings by the ACIP to discuss the approval of the promoters for the general public, although no formal date has been announced; the FDA and its advisory committee are expected to meet in September as well.