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Despite lack of clinical data, FDA approves COVID-19 boosters

COVID-19 vaccine booster shots were approved by U.S. drug regulators on Aug. 31 despite the lack of clinical trials for the updated formulation.

Moderna and Pfizer were granted emergency use authorization for their updated boosters by the U.S. Food and Drug Administration (FDA).

A strain of the virus that causes COVID-19 known as the Wuhan strain was used in the original vaccines. Wuhan strain components are included in the updated shots, as well as BA.4 and BA.5 subvariants of the Omicron variant.

“The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

According to the FDA's commissioner, Dr. Robert Califf, everyone who is eligible for an updated booster shot should get one in order to protect themselves from currently circulating variants.

The authorizations came just eight days after Moderna requested authorization, and nine days after Pfizer requested authorization.

31 August 2022


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