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FDA Approves NUVAXOVID COVID-19 Vaccine — But With Unusual Restrictions

Updated on July 2nd, 2025

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Written and medically reviewed by Dorcas Morak, Pharm.D

If you’ve been wary of newer mRNA vaccines like Pfizer and Moderna, NUVAXOVID by Novavax, Inc. offers an alternative — a traditional protein-based vaccine using decades-old technology. And now, it has FDA approval — though with some surprising limitations.

Why Is There a Restriction on the Use of the NUVAXOVID COVID-19 Vaccine?

Unlike most FDA-approved vaccines, NUVAXOVID is currently restricted to adults 65+ or individuals aged 12–64 with certain high-risk health conditions. While the FDA hasn’t publicly explained its decision, reports suggest the agency had initially intended broader approval by April 1. That changed abruptly, with the FDA now requesting additional studies — particularly around potential heart-related side effects.

What Makes NUVAXOVID Different from Pfizer and Moderna Vaccines?

It’s all in the science. Pfizer and Moderna use mRNA-based technology to instruct cells to create a spike protein that triggers an immune response. NUVAXOVID, on the other hand, uses a subunit protein combined with an immune-boosting adjuvant (Matrix-M) — a method proven effective in vaccines for hepatitis B and whooping cough.

This distinction is important. Some individuals have avoided mRNA vaccines due to uncertainty or mistrust. For them, NUVAXOVID offers a more familiar approach — though it’s only available to those who meet the FDA's current eligibility criteria.

What Does This Mean for the Next Round of COVID-19 Boosters?

This fall, CDC advisors are expected to decide whether COVID-19 boosters should be recommended for the general population or just for high-risk groups. The FDA’s narrowed approval of NUVAXOVID may be an early indication of a broader shift in federal policy — away from universal booster campaigns and toward more targeted recommendations.

In recent seasons, booster uptake has declined sharply across all age groups, with many younger, healthy individuals opting out. Public health officials are now evaluating whether annual COVID-19 boosters should follow a model more like the flu shot — prioritized for older adults, people with chronic conditions, and those with weakened immune systems.

Additionally, with new variants continuing to emerge, updated vaccine formulations may be timed with the fall respiratory illness season. Both mRNA vaccines and NUVAXOVID are expected to be evaluated for variant-specific effectiveness, which could further influence booster strategy.

As a result, some individuals may find themselves excluded from newer options like NUVAXOVID — at least for now. The FDA’s narrowed approval for NUVAXOVID may signal a shift toward a more targeted booster strategy, focusing on older adults and those with chronic conditions.

What If I’m Not Eligible but Still Want a NUVAXOVID Vaccine?

If you're under 65 and generally healthy, Pfizer and Moderna vaccines are still fully licensed for individuals 12 and older and are authorized for children as young as 6 months. These remain your primary options for COVID-19 protection and are widely available through doctors’ offices, pharmacies, and health clinics.

If you’re interested in NUVAXOVID specifically — perhaps due to concerns about mRNA technology — it may be worth discussing with your provider. In some cases, exceptions may be granted under medical guidance. Additionally, pending results from ongoing trials could eventually expand eligibility to more people, particularly those aged 50–64 without underlying conditions.

In the meantime, continue following CDC guidance and stay current on booster recommendations for your age and risk group.

What Happens Next for NUVAXOVID?

While the FDA has granted NUVAXOVID limited approval, Novavax, Inc. must now conduct additional studies — including one assessing benefits in adults aged 50 to 64 without existing health risks. This could potentially broaden its future use.

What Should You Do Now?

Whether you’re newly eligible for NUVAXOVID or still exploring your COVID-19 vaccine options, don’t let uncertainty stand in the way of protection. Talk to your healthcare provider about what’s best for you — and check the RxLess™ Assurance Plan for discounts on vaccines and medications related to qualifying health conditions. Participating pharmacies may offer significantly reduced prices on select immunizations, including COVID-19 vaccines.

Stay informed. Stay protected. And explore all your options to make the best decision for your health.

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