Pfizer’s COVID-19 booster has been approved by the FDA for those over 65 who are at high risk.
The third booster dosage of the Pfizer-BioNTech COVID-19 vaccine was approved by the Food and Drug Administration on Wednesday.
The FDA provided an emergency clearance allowing booster doses for those aged 65 and over, as well as those aged 18 to 64, who are at high risk of severe COVID-19 and are exposed to COVID-19 often in institutions or at work.
“FDA amended the [emergency use authorization]for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and daycare staff, grocery workers, and those in homeless shelters or prying eyes,” according to the FDA.
The booster dose should be given six months after the usual two-dose regimen, according to the CDC.
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted on Friday to approve a third dose based on the same standards.
In a statement, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “The FDA weighed the committee’s input and performed its own careful evaluation of the presented data to make today’s conclusion.” “We will continue to review data provided to the FDA on the use of booster doses of COVID-19 vaccines and make appropriate choices based on the facts,” says the company.
The FDA’s Vaccines and Related Biological Products Advisory Committee’s decision on Friday thwarted the Biden administration’s plans to start offering booster injections to practically everyone this week.
A committee of FDA scientists said last week that a third dosage of Pfizer’s vaccine likely boosts antibodies and provides better protection against COVID-19. They did not, however, go so far as to suggest that the extra dose is required by the majority of Americans. They claim that, despite losing immunity over time, the Pfizer vaccine’s two-shot regimen still protects against severe COVID-19 infections.
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention met on Wednesday to discuss the suggestion for a third dosage.
The advisory panel was scheduled to meet for ten hours on Wednesday to consider the matter.
The CDC and its experts must still submit comprehensive recommendations on who should receive the booster doses before they are made available following Wednesday’s approval.
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