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US Food and Drug Administration late Wednesday Authorized Booster Dose of Pfizer/BioNTech Kovid-19 Vaccine For people aged 65 and over. Eligible for a booster would be those who are 18 to 64 years of age who are at high risk of severe COVID-19 or are at high risk from persistent occupational or institutional exposure to SARS-CoV-2, such as healthcare workers and educators.

A single booster dose should be given at least six months after the initial two doses. The approval comes in an emergency use authorization amendment.

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The FDA’s authorization largely follows the recommendations of a committee of independent experts that advises the agency, known as the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. The committee met throughout the day on Friday to review and deliberate on the data surrounding the booster. The meeting ended with an 18-0 vote in favor of recommending a booster for people over 65 and high-risk groups. But, before that, the committee voted 16-2 against recommending boosters for everyone age 16 and older, rejecting the Biden administration’s plan to give extra doses to nearly all vaccinated people.

eligibility

Although the FDA has heeded the committee’s advice, it is still not entirely clear who will qualify for a booster dose. During discussions on Friday, experts suggested that people at high risk of serious disease could include people with conditions such as diabetes and obesity. It is not clear what other terms may be included.

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The committee made it clear that boosters should be available for healthcare workers who are at high risk of exposure. Those workers are already in short supply as the health system is being overwhelmed in the current surge of COVID-19. Experts and FDA officials also discussed frontline workers, teachers and prison personnel.

The FDA’s authorization on Wednesday is stated more vaguely because “people whose persistent institutional or occupational exposure to SARS-CoV-2 puts them at higher risk of serious complications of COVID-19, including severe COVID-19.” also includes.” In an accompanying statement, Acting FDA Commissioner Janet Woodcock elaborated, the authority covered “certain populations such as health care workers, teachers and day care staff, grocery workers and others in homeless shelters or prisons.”

The details of who those “others” are and which medical conditions will be covered will fall on an advisory committee to the Centers for Disease Control and Prevention. The committee—the Advisory Committee on Immunization Practices or ACIP—will meet tomorrow to set recommendations for the use of the booster.

“Dynamic and Evolving”

Another important issue that is likely to come up in the ACIP meeting is whether people who have received two doses of the Moderna mRNA vaccine or the one shot Johnson & Johnson vaccination should also be allowed to receive the Pfizer/BioNtech mRNA booster. can. FDA authorization only applies to people who have received two initial doses of the Pfizer/BioNTech vaccine. And boosters for vaccines from Moderna and Johnson & Johnson are in the works, but have not yet been authorized.

Hanging on the discussion is also speculation that whatever booster policies are set tomorrow, they will be short-lived. Movement on boosters for other vaccines is expected in the coming weeks and eligibility for the Pfizer/BioNTech booster may also open up. Top infectious disease expert Anthony Fauci told NPR’s Morning Edition on Monday that he expects more data in the coming weeks to help the FDA “Actually modify and expand the recommendation

In its statement on Wednesday, the FDA’s Woodcock said that “this pandemic is dynamic and evolving, with new data becoming available every day about vaccine safety and effectiveness. As we learn more about the safety and effectiveness of COVID-19 vaccines.” To learn more about this, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

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