FDA panel rejects COVID-19 booster shots for most Americans

FDA advisory committee rejects COVID-19 booster shots for Americans aged 16 and over, but approves boosters for 65+ and high risk individuals.

Elad Benari, Canada , | updated: 11:30 PM

FDA building, Wash. D.C.
FDA building, Wash. D.C.
iStock

A panel of expert outside advisers to the US Food and Drug Administration (FDA) on Friday voted against a proposal to administer a third vaccine shot to all people over the age of 16 by a vote of 2-16.

In a second vote, the panel unanimously approved the booster shots to people 65 and older, as well as for high risk individuals.

During the deliberations before the first vote, panel members suggested older, vulnerable populations may benefit from boosters, but noted insufficient data among younger groups and concerns over potential increased risk for heart inflammation, particularly among males ages 16-17, the report noted.

The committee was charged with voting whether the safety and effectiveness data from Pfizer's clinical trial supported approval of the company's booster dose among people 16 years and older.

The meeting included members of the FDA's Vaccines and Related Biological Products Advisory Committee, (VRBPAC), as well as officials from the Centers for Disease Control and Prevention (CDC), Israel’s Health Ministry, vaccine experts and Pfizer representatives.

The FDA will take the panel's recommendation into consideration in making its decision on the boosters, but it can reject the advice.

The FDA had approved booster shots of the COVID-19 vaccine only for transplant recipients or others with weakened immune systems.

The two-shot Pfizer COVID-19 vaccine received full FDA approval in August, also for those ages 16 and older.

Israel is already administering third doses of the vaccines. Britain began offering booster vaccines against COVID-19 this month, and Germany also announced it will do so.

The World Health Organization has criticized the booster campaigns, arguing that the vaccines should be reserved for poorer countries where many people have not yet even received one dose of a COVID vaccine.

(Arutz Sheva’s North American desk is keeping you updated until the start of Shabbat in New York. The time posted automatically on all Arutz Sheva articles, however, is Israeli time.)



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