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Key decisions on Pfizer Covid-19 vaccine enhancers for all adults may come this week




The US Food and Drug Administration is currently considering Pfizer and BioNTech’s request to change the emergency use authorization for their Covid-19 vaccine so that all adults will be eligible for a booster injection; Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, told CNN that the request was the center’s “highest priority.”

On Tuesday, the agency confirmed that their vaccine advisors, the Vaccines and Related Biological Products Advisory Committee, will not be convened to review the booster EUA decision – meaning the FDA’s authorization decision may come at any time.

“Although the FDA can not predict how long the evaluation of the data and information will take, the agency will assess the request as soon as possible,”[ads1]; FDA spokeswoman Alison Hunt told CNN.

On Tuesday, CDC spokesman Jason McDonald said the U.S. Centers for Disease Control and Prevention’s advisory committee on immunization practices will meet Friday to discuss booster qualification extensions for Pfizer’s Covid-19 vaccine. CDC vaccine advisors usually meet only when a vaccine has received FDA authorization.

Source: The FDA is likely to make a booster decision without an external advisory committee weighing in

If the FDA authorizes boosters for all adults and CDC vaccine advisors support recommending them, CDC Director Dr. Rochelle Walensky must sign the recommendation before it can be officially administered.

However, the majority of adults are already eligible to receive boosters. The FDA had already approved boosters for all 65 years and older who were vaccinated at least six months ago and for certain adults at high risk for infection or serious illness. Recent studies suggest that while vaccination still provides strong protection against serious illness and death months later, immunity may begin to decline and protection against milder and asymptomatic disease may decline. Studies also show that booster doses restore that immunity.

And with Covid-19 cases on the rise, some states and cities are choosing not to wait for official deregistration from the FDA or CDC, and have already opened up boosters for all adults.

Need for transparency

FDA vaccine advisors usually meet to discuss a requested EUA change and provide a recommendation on how the agency should proceed. This time, the FDA has concluded that Pfizer / BioNTech’s request does not raise issues that would require further discussion by the Advisory Committee, which consists of experts who do not work for the agency.

Dr. Arnold Monto, acting chairman of the FDA’s advisory committee, told CNN last week that there is a precedent for the FDA to choose not to consult its advisory committee on vaccines on certain decisions, noting that members of the committee meet “at the FDA’s discretion. “and that it can be” difficult “to convene members, which makes it difficult to react quickly to changing circumstances.

But Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, told CNN last week that he thought meetings with both the FDA’s and the CDC’s vaccine advisers were “the best way for us to be transparent” about Covid-19 vaccine enhancers.

“I think we need to show why a booster dose is clearly in favor of 18-29 year olds, because if it is not clearly beneficial, we need to consider the fact that myocarditis was a second dose phenomenon and may also be a third dose phenomenon. Do the benefits clearly and definitely outweigh the risks for 18-29 year olds? ” Offit sa.

Dr. Grace Lee, a member of the CDC’s Advisory Committee on Vaccines, noted that the ACIP meeting will provide the public with an overview of the vaccine enhancer data once it has been approved by the FDA.

“We know that Pfizer submitted a request to the FDA, and I expect that as soon as the FDA makes the decision, ACIP will discuss this in an open meeting where the public can see all the data in hand,” said Lee, a pediatrician at Stanford University School. of Medicine.



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