Wed. Oct 27th, 2021


White House article article Covid-1B may clash with CDC and FDA experts over booster shot

Pictures: Michael Sieglow (Getty Images)

There seems to be growing tension between the Biden administration and at least some people associated with the public health agency about the recommendation. Covid-1 boo booster shot Two senior officials from the Food and Drug Administration are reportedly leaving for next month, due to the White House’s decision to make a booster promise to the public without clearing it with the FDA. Meanwhile, some outside advisory members With the CDC recently hinting that they support a slower rollout for boosters, it is probably recommended for the weakest 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 longtime executives who have played a key role in many vaccine rollouts, including three Covid-1 vaccines approved and approved by the US Gruber, currently head of the FDA’s Vaccine Research Office, and Review, and has worked at the FDA for 32 years, while Krauss is a deputy director there, with more than 10 years of FDA experience.

Former FDA Officers Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, praised the staff for their two-year service in a letter to Received By Biopharma dive. However, these departures may not be in perfect condition. A former senior FDA official, quoting a discussion with Endpoint News Report That men have been frustrated for some time to make decisions Covid-1 vaccine

Much of this reported frustration was with the CDC and outside experts having to decide with an advisory committee that they thought the FDA should be left to its own devices. But the obvious final straw was when the White House Announced Last month it would approve a booster for the general public by September 20th. Joint Statement Several key officials, including the FDA and CDC, announced the move, but noted that it would be official only if the FDA and CDC formally signed it.

Part of this process will include discussions by the CDC’s Advisory Committee on Immunization Practices (ACIP), whose guidelines affect the timing and administration of vaccines approved or approved by the FDA. ACIP on Monday afternoon Combined To discuss and unanimously recommend the use of the now approved Pfizer / Biotech vaccine for those 16 years of age and older. But while they have briefly discussed booster shots, some have expressed more skepticism about their needs right now than at the White House.

There is a general agreement that a booster dose will at least temporarily reduce the risk of any infection:And possibly infectionTo vaccinate, but whether to debate These shots are currently needed to protect people from being hospitalized and death is on the rise. Some at the ACIP meeting argued that vaccinated people should pay more attention to taking their first shots instead of approving helpers at this time, how safe it is Against serious illness and death.

“We have a lot of vaccines. Now, There is not much evidence that our vaccine has been shown to be effective, ”said Beth Bell, a doctor and clinical professor of global health at the University of Washington in Seattle.

Others argued that the United States could work harder to provide unspecified vaccines, and still confirm that boosters are provided to the most at-risk groups from the epidemic to serious illness, such as the elderly. Last month, ACIP approved a third dose of the mRNA vaccine for immunocompromised people, moving forward not as a booster but as part of a standard schedule, evidence that these individuals develop a weakened immune system.

Israel is a country that has come a long way in providing booster to its citizens. Preliminary data from there suggest that the booster may recover some levels Protection Against infection from coronavirus, as well as possibly to reduce its risk Serious illness Which seemed to have increased among the first residents to be vaccinated late last year. But there are other scientists Questionable Whether the data from Israel has really significantly reduced the effectiveness of the vaccine against serious illnesses, as their officials have claimed. Most of the data is from elsewhere, including the United States Found Protection against the worst results is very high, even with the Delta variant.

There Expected Additional meetings must be held by the ACIP to debate the approval of donors for the general public, although no official date has been announced; The FDA and its advisory committee are also expected to meet in September.





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