WASHINGTON: The US Food and Drug Administration (FDA) has approved Novavax’s Covid-19 vaccine, Nuvaxovid, but only for limited use in specific age and health groups. The decision was announced on Friday and marks a key moment for the company.
According to the FDA, the vaccine is now approved for people aged 65 and older, and for individuals aged 12 to 64 who have at least one health condition that increases their risk of severe illness from Covid-19. However, the agency did not define what qualifies as an “underlying condition.”
In addition, the FDA delayed pediatric studies for children under 12 years old, as clinical trials for that age group have not yet been completed. This means younger children remain ineligible for the Novavax shot at this time.
Novavax CEO John Jacobs welcomed the approval, calling it a “significant milestone” that provides a clearer path for people to access their vaccine. He added that the company remains committed to offering a reliable alternative to mRNA-based vaccines.
Earlier, the vaccine’s future had appeared uncertain after the FDA missed its April 1 deadline for approval. US Health and Human Services Secretary Robert F. Kennedy Jr. had pointed to concerns over the vaccine’s composition during an interview in April.
Unlike Pfizer and Moderna’s mRNA vaccines, Novavax uses older protein-based technology. While this makes it a preferred option for some, the company missed out on early pandemic profits due to production delays and regulatory challenges.