FDA Grants Conditional Approval to Novavax COVID-19 Vaccine for High-Risk Groups

Novavax COVID-19 Vaccine Gets Conditional FDA Approval for Vulnerable Populations

Written by: Supriya Kadu

Edited by: Pinky Deshmukh

Last Updated: May 19, 2025

Summary: The FDA has authorized Novavax's COVID-19 vaccination for elderly and high-risk patients, with additional safety studies and use restrictions.

In a key step forward in the ongoing fight against COVID-19, the US Food and Drug Administration (FDA) has granted full approval to Novavax's COVID-19 vaccine, Nuvaxovid, under limited conditions. The vaccine is now officially recommended for use in adults 65 and older, as well as people aged 12 to 64 who have specific underlying health conditions that render them more susceptible to severe COVID-19.

Unlike the broader permission granted to Pfizer-BioNTech and Moderna vaccines, which are available to all individuals aged six months and up, Novavax's approval is more limited in scope. The FDA has yet to define which health issues are considered "high risk," creating some ambiguity for clinicians and patients.

This approval comes after a delay from the FDA’s original decision timeline, which had aimed for a verdict by April 1. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. stated that the delay stemmed from concerns over the vaccine’s composition.

Novavax’s vaccine, which is protein-based and not mRNA like the other two main vaccines, has been viewed as an important alternative for people hesitant about newer vaccine technologies. The vaccine was previously only available under emergency use authorization.

As part of the approval conditions, Novavax is now required to conduct post-marketing studies. These studies will evaluate long-term safety and the vaccine’s effects on heart health, especially in adults aged 50 to 64 without qualifying risk factors.

Novavax CEO John C. Jacobs applauded the decision, highlighting the company's dedication to delivering safe and effective vaccine choices for vulnerable populations.

The Centers for Disease Control and Prevention (CDC) is anticipated to provide fresh vaccine recommendations next month, which may influence the continued use of the Novavax shot.

With this new approval, healthcare providers are being encouraged to carefully evaluate patients’ medical histories before prescribing the vaccine, ensuring it’s administered to those who will benefit most.