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FDA Advisory Panel to Meet on COVID Booster Shots

HealthDay News
by Cara Murez
Updated: Sep 17th 2021

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FRIDAY, Sept. 17, 2021 (HealthDay News) -- U.S. Food and Drug Administration advisors will meet Friday to consider whether it is safe and effective for Americans to receive a third "booster" dose of the Pfizer-BioNTech COVID-19 vaccine.

The FDA posted the materials it intends to use in the review on Wednesday. The advisory panel will review a variety of evidence, including new data from Israel, the Associated Press reported. Israel began offering boosters to its citizens this summer.

In the Israeli study, published Wednesday in the New England Journal of Medicine, one million people aged 60 and older got a third dose. The data shows they were much less likely to become infected soon afterward when the contagious Delta variant was spreading, achieving what Pfizer called "roughly 95% effectiveness." It is not known how long that protection will last.

However, in summarizing other evidence that will be included in Friday's meeting, the FDA wrote that the original two doses of the Pfizer-BioNTech and other U.S.-authorized COVID-19 vaccines "still afford protection against severe COVID-19 disease and death in the United States."

FDA reviewers suggested they would primarily focus not on the Israeli data but on how vaccines have worked among Americans, which they said "may most accurately represent vaccine effectiveness in the U.S. population."

Pfizer, meanwhile, has indicated that its vaccine is protecting against severe disease in the United States, but immunity against milder infections wanes around six to eight months after the second dose.

Pfizer gave third doses to 306 individuals and found they had threefold higher antibodies than after earlier doses. The company said the antibodies appeared strong enough to be effective for the Delta variant.

The issue of whether or not booster shots are needed has heated up over recent weeks, after President Joe Biden had previously announced a booster campaign that was slated to begin Sept. 20 — Monday. But soon after that announcement two top FDA vaccine regulators joined with other international scientists to release a report contending that boosters are not needed for healthy individuals, because the vaccines continue to offer strong protection from severe disease.

Although the FDA is not bound to follow the advice of its advisory committees, it typically does so.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccines.

SOURCE: Associated Press, Sept. 16, 2021