U.S. FDA Authorizes Novavax’s COVID-19 Vaccine for Emergency Use

The United States Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for emergency use for adults on July 13.

The Novavax vaccine is administered as a two-dose primary series, three weeks apart, for individuals ages 18 and older, the FDA announced.

Clinical trial results, which are published in The New England Journal of Medicine, show that the vaccine is 90.4% effective against COVID-19.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Dr. Robert Califf said in a statement.

Novavax President and Chief Executive Officer Stanley Erck said in a statement that the authorization “underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”

The Centers for Disease Control and Prevention (CDC) is expected to review and issue their own recommendation on the vaccine.

The CDC’s Advisory Committee on Immunization Practices is scheduled to meet on July 19.

Some health experts have suggested that Americans who are hesitant to get receive the other available vaccines may be more inclined to get the Novavax vaccine because it uses a more traditional protein-based technology.

According to CDC data, 78.4% of the U.S. population has received at least one dose of a COVID-19 vaccine.


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