The Food and Drug Administration on Wednesday cleared a third dose of the Pfizer-BioNTech Covid-19 vaccine for emergency use in people 65 years of age and older, as well as those at high risk of exposure to coronavirus or disease. serious. Boosters should be given six months after a person has received their second dose of Pfizer vaccine.
The FDA decision came as an advisory group from the Centers for Disease Control and Prevention held a two-day meeting on the safety and effectiveness of the Pfizer recall. On Thursday, those advisers will vote on who would qualify for a third shot.
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Approval from the CDC group, known as the Immunization Practices Advisory Committee, is required before booster shots can be administered.
However, the timing of the FDA decision has cast an air of uncertainty on the first day of the ACIP meeting, which usually knows up front which FDA decision it will consider. Instead, the FDA announcement didn’t come until after Wednesday’s meeting ended.
Pfizer initially asked the FDA to consider a third dose for all people 16 years of age and older, six months after receiving their second dose. Last Friday, an FDA advisory committee rejected the request, limiting the recall to the elderly and those most at risk of becoming seriously ill from Covid-19.
The FDA advisory committee also suggested that people at high risk of workplace exposure, such as healthcare workers and teachers, should also be eligible for a booster dose. This was reflected in the EUA on Wednesday.
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The booster dose is aimed at combating the decline in immunity of the original vaccine series. Data from Israel, presented at Friday’s advisory committee meeting, suggests protection against Pfizer’s vaccine drops dramatically after six months, although US data shows less decline, especially against disease serious. The first data from Israel also showed that a booster dose offered better protection against infection.
In denying Pfizer’s original request – that a booster be made available to all people 16 years of age and older – the FDA committee raised concerns about possible side effects of the vaccine, such as myocarditis, in young adults.
ACIP members also adopted a skeptical tone for much of Wednesday’s discussion of booster doses. In addition to requests for additional data, committee members wanted more clarity on the specific purpose of a booster dose: does it prevent all disease, or only serious disease?
Another thorny question that CDC advisers will continue to discuss on Thursday is what people who were initially vaccinated with Moderna or Johnson & Johnson should do, as Wednesday’s emergency use clearance only included people who have received the Pfizer vaccine.
“This will leave half of those vaccinated to be told they are at risk now or that they are in decline in immunity and hospitalization and unable to get a booster dose. This is a big one. public health panic that we would like to avoid, ”said ACIP member Dr. Sarah Long, professor of pediatrics at Drexel University College of Medicine in Philadelphia.
Moderna has submitted data on its booster dose to the FDA, and Johnson & Johnson is working on doing the same.
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Reynolds lewis contributed.