FDA Approves Novavax COVID Vaccine After Delay, Limits Use to Smaller High-Risk Population

The FDA has granted full approval for Novavax's COVID-19 vaccine, Nuvaxovid, after a six-week delay from the expected decision date in April 2025135.

This approval is narrowly restricted:
the vaccine is authorized only for people aged 65 and older, and for individuals aged 12 to 64 who have underlying health conditions that increase their risk for severe COVID-19135.

The FDA is requiring Novavax to conduct an additional randomized, double-blind, placebo-controlled trial in people aged 50 to 65 without high-risk conditions to further assess safety and efficacy15.

Nuvaxovid is the only protein-based COVID-19 vaccine option approved in the U.S., in contrast to the broadly available mRNA vaccines from Moderna and Pfizer135.

While the European Union, UK, Japan, Canada, Australia, Taiwan, and Singapore have fully approved Novavax's shot without such restrictions, the FDA's decision narrows its eligible population in the U.S.1.

Novavax's CEO emphasized the importance of offering a protein-based alternative for high-risk and older populations, citing market research showing these groups are most likely to seek out COVID-19 vaccinations seasonally35.

The vaccine has been available in the U.S. under emergency use authorization since July 2022135.

Sources:

1. https://www.cidrap.umn.edu/covid-19/fda-approves-full-license-novavaxs-covid-vaccine

3. https://www.fiercepharma.com/pharma/following-fda-holdup-novavax-secures-full-approval-protein-based-covid-vaccine

5. https://www.biopharmadive.com/news/novavax-covid-vaccine-fda-approval-restrictions/748447/