Tue May 20 07:20:00 UTC 2025: Okay, here’s a summary and rewritten news article based on the provided text:

**Summary:**

The FDA has granted full approval to Novavax’s COVID-19 vaccine, but with unexpected restrictions. The approval is limited to adults 65 and older or those aged 12-64 with pre-existing health conditions. This contrasts with Pfizer and Moderna vaccines, which have broader full approvals for those 12 and older. The decision raises questions about the future of universal COVID-19 vaccine recommendations and potentially reflects skepticism from some officials. Further trials are required to study potential heart-related side effects and the benefits of vaccination in lower-risk populations.

**News Article:**

**FDA Approves Novavax COVID-19 Vaccine, but Restricts Use to Older and High-Risk Adults**

**Washington, D.C. (AP)** – The Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, offering the nation’s only traditional protein-based option. However, the approval comes with surprising limitations, restricting its use to adults aged 65 and older, or individuals between 12 and 64 with at least one health condition that elevates their risk from COVID-19.

This decision sets Novavax apart from its competitors, Pfizer and Moderna, whose vaccines are fully licensed for broader use in anyone 12 and older.

The FDA’s move raises questions about the future of universal COVID-19 vaccine recommendations. The CDC is scheduled to debate whether yearly COVID-19 vaccines should be recommended for everyone or just those at higher risk.

“Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” said Novavax CEO John C. Jacobs, “This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.”

The FDA’s decision letter did not explicitly explain the restrictions, but sources suggest the limitations may reflect skepticism towards vaccines within certain circles, despite the vaccine demonstrating safety and efficacy in initial clinical trials.

Adding another layer of complexity, the FDA is requiring Novavax to conduct additional trials post-approval. Some trials will investigate potential links between the vaccine and heart conditions, while another is required to assess the benefits of continued vaccination in 50- to 64-year-olds without underlying health problems.

The Novavax vaccine offers a different technological approach compared to mRNA vaccines from Pfizer and Moderna. Some individuals who are hesitant about mRNA technology may find the protein-based Novavax vaccine a more appealing option, despite the restricted availability.

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