FDA Authorizes New COVID-19 Vaccine Without Clinical Data

The U.S. Food and Drug Administration 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.

"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.

The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid technology earlier in the month.

"The assertion rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated," Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times previously via email.

Company officials told FDA advisers over the summer that they were planning to continue manufacturing a JN.1-based vaccine and believed it would perform well against KP.3 and other strains from the JN.1 lineage.

People who have never received a vaccine can get two doses of Novavax's vaccine about three weeks apart. 

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