Home Business FDA authorizes Novavax’s updated COVID vaccine for fall 2023

FDA authorizes Novavax’s updated COVID vaccine for fall 2023

by Mark Mendoza

The Food and Drug Administration (FDA) has authorized Novavax’s updated COVID-19 vaccine, providing Americans with a third option for vaccination. The updated shot is designed to target the XBB strains of the virus, which are currently the dominant strains in circulation. This updated formulation is similar to the revised versions of the Moderna and Pfizer vaccines that were approved last month.

The Moderna and Pfizer vaccines are based on mRNA technology, while Novavax’s vaccine follows a different approach. Novavax’s authorization offers people a protein-based non-mRNA option to protect themselves against COVID-19. This is significant as COVID-19 is now the fourth leading cause of death in the United States.

The FDA’s authorization is the final major regulatory step required before Novavax’s new shots can be rolled out. The vaccine meets the FDA’s standards for safety, effectiveness, and manufacturing quality necessary to support emergency use authorization. The Centers for Disease Control and Prevention (CDC) has confirmed that closely related descendants of the XBB variant continue to be the dominant strains of coronavirus circulating nationwide.

The authorization also marks the first time that many previously vaccinated Americans will be eligible to receive the Novavax vaccine. Previously, Novavax was only authorized as a first booster dose for individuals who were unwilling or unable to receive an mRNA vaccine.

Novavax has stated that it has “millions of doses” of its vaccine available in the U.S., which will be shipped out once the FDA approves each batch. The company has partnered with national drug stores and doctors’ offices to make the vaccine available at thousands of locations. The shots will also be accessible through the federal Bridge Access and Vaccines for Children program.

Novavax’s authorization comes later than anticipated, as the company had aimed to enter the U.S. market by September. The reasons for the delay are not entirely clear, but the company worked closely with the FDA to ensure that a protein-based option would be available this fall. It is possible that the timing of the applications, as well as the longer manufacturing process for non-mRNA vaccines, contributed to the delay.

While Novavax’s vaccine is now available for individuals aged 12 and older, authorization for younger children is expected to come at a later time, possibly in the coming year. The authorization of Novavax’s vaccine provides Americans with another reliable option to protect themselves against COVID-19, ultimately contributing to efforts to control the pandemic.

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