FDA Authorizes New COVID-19 Vaccine Without Clinical Data

The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer.

Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product.

FDA officials said that animal testing data supported the decision.

“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 30 statement.

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