FDA Authorizes Updated Novavax COVID-19 Vaccine 

October 3, 2023 by Dan McCue
FDA Authorizes Updated Novavax COVID-19 Vaccine 
(Novavax photo)

WASHINGTON — The Food and Drug Administration on Tuesday amended its emergency use authorization for the Novavax COVID-19 vaccine, approving an updated version of the vaccine for use by previously vaccinated individuals aged 12 and older.

Of course, those who have already been vaccinated with the recently updated mRNA COVID-19 vaccine should not get the new Novavax shot, the agency said.

Individuals who were previously vaccinated and have not gotten the new booster are eligible to receive one dose of the Novavax vaccine. Unvaccinated individuals may receive two doses.

“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” said Dr. Peter Marks, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

“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,” Marks said.

The FDA says the updated Novavax vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. 

To do that it has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).

This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc.

As part of Tuesday’s action, the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.

“As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” Marks said.

Dan can be reached at [email protected] and @DanMcCue

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