FDA approves Novavax's Covid-19 vaccine with limitations

Published: Sunday, May 18, 2025 at 11:43 pm

FDA Approves Novavax COVID-19 Vaccine with Limited Scope

The U.S. Food and Drug Administration (FDA) has approved Novavax's COVID-19 vaccine, Nuvaxovid, but with specific limitations. The approval, which follows a six-week delay, is currently restricted to individuals aged 65 and older, as well as those aged 12 and older with at least one underlying health condition that puts them at higher risk of severe illness. These conditions include asthma, diabetes, lung disease, obesity, and pregnancy.

This decision marks a significant step for Novavax, a Gaithersburg, Maryland-based company, which uses a more traditional protein-based vaccine technology compared to the mRNA vaccines developed by Pfizer and Moderna. Novavax's President and CEO, John Jacobs, emphasized the company's commitment to providing a vaccine option for those most likely to seek seasonal COVID-19 vaccinations.

The Novavax vaccine has been available under emergency use authorization since 2022, with an updated version approved in August 2024. While Pfizer and Moderna received full FDA approval earlier, they remain available under emergency use authorization for younger children.

The FDA's decision comes amidst a changing landscape for COVID-19 vaccine recommendations. The CDC is considering yearly vaccine recommendations, potentially focusing on older adults and those with compromised immune systems. The CDC currently recommends a yearly dose for everyone aged six months and older. The FDA's decision was delayed as it sought more data, and Novavax is now required to conduct postmarketing studies to assess the risk of myocarditis and pericarditis, rare heart inflammation conditions, in vaccine recipients.

BNN's Perspective: The FDA's cautious approach, focusing on high-risk groups and requiring further study, reflects a responsible approach to vaccine approvals. While the limitations may disappoint some, they also demonstrate a commitment to safety and data-driven decision-making. The ongoing evolution of vaccine recommendations highlights the need for continued monitoring and adaptation as we learn more about the virus and its impact.

Keywords: FDA, Novavax, COVID-19 vaccine, Nuvaxovid, approval, age restrictions, underlying conditions, myocarditis, pericarditis, CDC, protein-based vaccine, Pfizer, Moderna, vaccine recommendations, health, safety, vaccine hesitancy

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