Novavax's COVID-19 Vaccine Receives FDA Approval with Limitations

The U.S. Food and Drug Administration has granted approval for Novavax's COVID-19 vaccine, but its use is limited to older adults and individuals aged 12 and older with preexisting conditions putting them at risk. This traditional protein-based vaccine faced uncertainty as the FDA missed its original approval target date of April 1.

Novavax's Chief Corporate Affairs and Advocacy Officer, Silvia Taylor, downplayed concerns about the limited approval, claiming it aligns with the primary demographic that seeks the vaccine. The CDC's expert panel has also recently been contemplating narrowing the recommendations for annual COVID-19 shots.

For future immunization seasons, Novavax, along with Moderna and Pfizer, will need to secure additional approvals to change the targeted strain of the virus. Novavax CEO John Jacobs hailed the FDA's decision as a significant milestone, while former FDA Chief Scientist Jesse Goodman criticized the agency for overstepping by limiting the approval to certain populations.

(With inputs from agencies.)