The Food and Drug Administration (FDA) authorized COVID-19 booster shots for some Americans — those who are either elderly or at risk of severe COVID-19 — beginning six months after vaccination.
The booster authorization, announced late Wednesday, only applies to Americans who received the Pfizer vaccine and comes after an independent FDA panel overwhelmingly rejected plans to recommend a blanket booster policy, regardless of age.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic. After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Dr. Janet Woodcock.
“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” she said.
The authorization also applies to “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”
The decision by the FDA comes after an FDA independent advisory panel announced last week that it would not pursue the booster policy President Joe Biden presented last month. The president, who acknowledged the plan would rely on FDA authorization, anticipated that boosters could be made available to the general public as soon as September 20.
“The plan is for every adult to get a booster shot eight months after you got your second shot,” Biden said on August 18, notes The New York Times. The president added, “It will make you safer, and for longer. And it will help us end the pandemic faster.”
But the plan hit a snag when there was insufficient data for the Moderna and Johnson & Johnson vaccine booster shot decision, an official told The New York Times earlier this month. Anticipating a delay in the process, two top health officials, including Woodcock, told the White House that the booster plan as outlined would likely not be possible.
Now that the FDA has made a decision, the Centers for Disease Control and Prevention (CDC) must make its own decision. According to Stat News, the CDC’s Advisory Committee on Immunization Practices is expected to vote on the issue Thursday, after which Director Dr. Rochelle Walensky can decide whether to go with the committee’s recommendations or not.
This article has been expanded after publication to include additional information.
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