- The FDA has fully approved Novavax’s protein-based COVID-19 vaccine, Nuvaxovid, for adults 65+ and 12–64-year-olds with underlying risk factors.
- Approval follows a post-marketing commitment to study efficacy in 50–64-year-olds without high-risk conditions and monitor heart-inflammation events.
- Sanofi will begin marketing later this year and has triggered a $175 million milestone payment to Novavax.
After nearly three years under Emergency Use Authorization, Nuvaxovid finally received full FDA approval—but only for adults aged 65 and older and for individuals aged 12–64 who have medical conditions that elevate their COVID-19 risk. Novavax has positioned its protein-based shot as an alternative to mRNA vaccines, banking on its appeal to older adults and those with comorbidities. John Jacobs, Novavax’s CEO, highlighted CDC data indicating these groups are the most likely to seek seasonal vaccination, and he called the approval “a significant step” toward making a protein-based option broadly available.
Post-Marketing Commitments and Political Delays
Novavax’s application faced unexpected delays after its anticipated April approval window passed amid reports of political intervention. Ultimately, the FDA approved Nuvaxovid contingent on two post-marketing studies: a Phase 4, placebo-controlled trial in 50–64-year-olds without high-risk conditions, and additional monitoring for myocarditis and pericarditis. Novavax is collaborating with Sanofi to secure funding and operationalize the efficacy trial.
Commercial Rollout and Future Recommendations
The full-approval decision immediately triggered a $175 million milestone payment from Sanofi—part of a $1.2 billion partnership struck last May—and shifts marketing duties to Sanofi later this year. Novavax anticipates delivering commercial doses this fall, pending strain selection at an upcoming FDA advisory meeting. Meanwhile, the CDC’s ACIP is likely to adopt a risk-based booster strategy for COVID-19, mirroring broader moves to tailor immunization policy to individual risk profiles rather than universal revaccination.
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Source: Fierce Pharma
