FDA authorizes Novavax COVID vaccine for emergency use

The two-dose Novavax COVID vaccine became the fourth coronavirus vaccine available in the United States after the Food and Drug Administration (FDA) authorized its emergency use in people over 18 to prevent COVID-19.

“This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues,” says Stanley C. Erck, President and CEO of Novavax, a BIO member company.

As we wrote before, the FDA’s Vaccines and Related Biological Products Advisory Committee held a meeting on June 28, during which the latest data from the Novavax COVID vaccine’s phase 3 clinical trials was presented showing “the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19.”

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D.

The doses of the protein-based vaccine, which can be stored in a standard vaccine refrigerator, are administered three weeks apart.

Experts hope that it will be more appealing to people who have refused mRNA vaccines or are allergic to some of their components.

“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,” said Dr. Califf.

Novavax has demonstrated broad cross-reactivity against Omicron and other circulating variants from a primary two-dose regimen, with responses that increased following the third dose at six months. The company is now testing the vaccine for use as an Omicron booster as well.

“The next step for Novavax before entering the market,” as Focus Washington reported, “is getting the endorsement of the Centers for Disease Control and Prevention (CDC), whose Advisory Committee on Immunization Practices is scheduled to convene on July 19,” though its agenda hasn’t been published yet.

The Biden administration announced an agreement to purchase 3.2 million doses of the Novavax vaccine, which will be made available at no cost to states, jurisdictions, federal pharmacy partners, and federally qualified health centers as soon as it gets a favorable recommendation from the CDC.

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