FDA Approves Novavax COVID-19 Vaccine for High-Risk Older, Underlying Condition Groups

The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax's protein-based COVID-19 vaccine, Nuvaxovid, but with significant restrictions limiting its use to adults 65 and older and individuals aged 12 to 64 with underlying health conditions that increase COVID-19 risk. This approval marks a departure from the broader emergency use authorization previously in place, reflecting hesitations within the FDA and signaling a more cautious regulatory stance. Novavax must conduct extensive post-approval studies, including costly trials to evaluate potential associations with heart conditions, which has raised concerns about the economic viability of vaccine production. The decision contrasts with the less restrictive authorizations for mRNA vaccines by Moderna and Pfizer, which remain approved for children as young as six months. Health experts and Novavax officials emphasize that the vaccine addresses the needs of high-risk populations, especially as booster shots and new vaccines become critical amid rising COVID-19 cases globally. However, the FDA's move has sparked debate on balancing vaccine safety with broader public health needs and availability.