Novavax Shares Soar After FDA Clears COVID Vaccine for High-Risk Groups, Offering Non-mRNA Option

Novavax saw its shares surge over 15% following the long-anticipated U.S. Food and Drug Administration (FDA) approval of its COVID-19 vaccine, Nuvaxovid. This decision helped ease concerns regarding the vaccine’s future, which had been uncertain due to previous regulatory delays. Although the approval comes with specific conditions, investors welcomed the clarity, signaling renewed confidence in the company’s prospects.

FDA Limits Novavax Use, Offers Alternative for mRNA Vaccine Skeptics Amid Questions

The FDA’s approval was limited to people aged 65 and older, as well as individuals 12 years and above with at least one underlying health condition that increases the risk of severe COVID-19. Analysts noted that these conditions were medically atypical, as such restrictions are usually outlined by the Centers for Disease Control and Prevention (CDC), not the FDA. Nonetheless, the move aligns with previous regulatory discussions and offers a path forward for the company.

Unlike its competitors Pfizer and Moderna, which use mRNA technology, Novavax’s shot is a protein-based vaccine. This provides an alternative for individuals hesitant to receive mRNA-based vaccines. Experts like William Schaffner from Vanderbilt University suggested that Nuvaxovid could serve as a “reassuring alternative” for this demographic. However, the unusual age-specific restrictions have raised questions about the approval process.

Novavax Prepares U.S. Rollout with Sanofi, Awaits Strain Update and Funding Plans

Looking ahead, Novavax plans to begin commercial distribution in the U.S. by the fall, in partnership with French pharmaceutical company Sanofi. The two companies have a licensing agreement in place, and they are awaiting FDA strain recommendations for the upcoming immunization season. Novavax, like other vaccine makers, must obtain additional regulatory clearance if it seeks to update its formula to target new COVID-19 variants.

As part of the approval, the FDA has requested Novavax conduct post-marketing studies in adults aged 50 to 64 who are not considered high-risk. The company is working with Sanofi to assess how best to fund and carry out this trial. Additionally, the approval triggered a $175 million milestone payment from Sanofi to Novavax, providing the company with a significant financial boost to support its next steps.