Authorization Granted for Protein-Based Boosters for Adults

Novavax, Inc. announced that the protein-based Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), had received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose of at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate.

And the EUA says adults can elect to receive the Novavax COVID-19 Vaccine, Adjuvanted, because they would otherwise not receive a booster dose of another COVID-19 vaccine.

As of October 19, 2022, U.S. Centers for Disease Control and Prevention (CDC) reporting indicates 35,302 doses of the vaccine have been administered. 

"The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster," said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a press release on October 19, 2022.

"According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose."

"Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults."

The next step for the vaccine is a policy recommendation from the CDC. 

According to Dr. Grace Lee, the CDC issued its recommendation on October 19, 2022.

This news indicates access to Novavax COVID-19 Vaccine, Adjuvanted, will soon be located on Vaccines.gov.

In the U.S., the FDA granted Novavax EUA for a two-dose primary series in adults aged 18 and older in July and for adolescents aged 12 through 17 in August 2022.

The Novavax COVID-19 Vaccine, Adjuvanted vaccine, has not been approved or licensed by the U.S. FDA but has been authorized.

Novavax's vaccine, known internationally as Nuvaxovid™ and CovoVax™, is also available for use as a booster in adults in the European Union, Japan, Australia, New Zealand, Switzerland, and Israel.

As of September 2022, Taiwan, Swiss, USA, Japan, Israel, India, Australia, New Zealand, South Korea, and the U.K. Medicines and Healthcare Products Regulatory Agency had authorized adolescents aged 12 through 17 to receive the Nuvaxovid vaccine.  

Maryland-based Novavax, Inc. is located in Gaithersburg, MD.

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