WEIS Radio | Local and regional news, sports and weather “FDA panel recommends Pfizer boosters for people over 65 or at high risk, vote” no “for general population


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(WASHINGTON) – Federal councilors on Friday voted 18-0 in favor of Pfizer’s recommendation for recalls for anyone over 65 or anyone at high risk of serious illness from COVID-19. However, the panel declined to recommend boosters for all Americans as young as 16 who took the Pfizer vaccine more than six months ago.

If the Food and Drug Administrations agree with the plan, which is likely, it is possible that booster injections will be deployed as early as next week for these populations. The Centers for Disease Control and Prevention would weigh in first, but with more specific recommendations on who exactly should take the third shots.

Members of the FDA’s Vaccines and Related Biologics Advisory Committee reviewed new data from Israel and questioned whether recalls are really needed, especially among younger populations.

The biggest sticking point was the lack of data on the effect boosters might have on young people, especially because 16 and 17 year olds were not included in the trial. Myocarditis, an inflammation of the heart, occurred mainly in young men, although very rarely, after their second dose of mRNA, so members wanted to see more data on the effects of a third injection.

While many Americans have already opted for a third injection, with doctors allowing it as an “off-label” practice, it’s up to federal regulators to decide how vaccines are labeled and administered.

The debate has become unusually busy, in part because of the White House’s involvement. President Joe Biden has said he will only act on the deployment of boosters if the FDA and CDC agree. But his public statement that the deployment would begin as early as Monday suggested the decision was won in advance, leading some scientists to accuse the Biden administration of pressuring independent regulators.

After FDA approval, the CDC will determine who exactly should receive a recall. Once the CDC recommendation was made, the booster would be available at any of the 40,000 pharmacies, doctor’s offices and other sites nationwide already offering the Pfizer vaccine.

The CDC said vaccines still offer extraordinary protection against hospitalization and death, with more than 90% of patients hospitalized with COVID-19 unvaccinated. During Friday’s FDA briefing, a CDC official said the vaccine’s effectiveness against hospitalization in adults 75 and older remained at around 88% until July.

But there were other signs that immunity was waning over time.

New Israeli study published in the New England Journal of Medicine found 11.3 times lower infection rates and 19.5 times lower rates of severe COVID-19 in people over 60 who received a dose reminder. In addition, an analysis by the Israeli Ministry of Health estimated that protection against infections and severe COVID-19 was about 10 times greater in people who received a booster.

Sharon Alroy-Preis, head of public health services at Israel’s Ministry of Health, said Israel became concerned when it saw cases of fully vaccinated residents infect other members of their household and – sometimes – end up hospitalized.

“We certainly see cases that are vaccinated – doubly vaccinated – that are no longer fresh” six months after their second dose, Alroy-Preis said. These vaccinated cases “infect other people. This is obviously less than unvaccinated. But we see it, especially in their homes.

Sony Salzman of ABC News contributed to this report.

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