FDA approves Novavax COVID vaccine under specific conditions

The U.S. Food and Drug Administration (FDA) has granted approval to Novavax's COVID-19 vaccine, Nuvaxovid, but with specific conditions limiting its use to certain groups.

The vaccine is authorized for individuals aged 65 and older, as well as for those aged 12 to 64 who have underlying conditions that heighten their risk of severe COVID-19. However, the approval letter did not detail what constitutes an underlying condition.

The FDA also deferred the submission of pediatric studies for children under 12, citing incomplete research.

Novavax CEO John Jacobs described the approval as a significant milestone, emphasizing its role in increasing vaccine accessibility.

Novavax, which uses an older protein-based vaccine technology, faced hurdles in manufacturing and regulatory processes. These challenges distinguished Novavax from RNA-based vaccine makers like Moderna and Pfizer, which thrived during the pandemic.

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