FDA Approves Novavax COVID Vaccine With Restricted Use
May 19, 2025 – The FDA has approved the Novavax COVID-19 vaccine, a protein-based alternative to mRNA shots, with some limits on who can get it.
The vaccine, called Nuvaxovid, is mainly intended for adults 65 or older. But people ages 12 to 64 with medical conditions that increase their risk of serious illness from COVID can also get the shot. It offers an alternative to the mRNA-based technology used in the most common COVID vaccines and has been used under emergency authorization since 2022. The new FDA decision grants its full approval for broader commercial use, but only for these specific eligible groups.
COVID is a disease caused by a virus called SARS-CoV-2, which spreads from person to person and infects the airways. While it gives some people only mild symptoms, older adults or those with certain health conditions – such as heart disease, diabetes, obesity, lung diseases like asthma or COPD, smoking, cancer, or weakened immunity – are at higher risk of serious illness. As the virus keeps changing, some of its newer versions can spread faster and may be more dangerous. Vaccination remains a key way to reduce the risk of serious illness, particularly in people at higher risk of severe outcomes.
The approval request for Nuvaxovid was supported by multiple large clinical trials that showed it could protect against COVID. The effect was consistent across various age groups and for those with or without health conditions. The FDA has requested post-approval studies to further see how safe and effective the vaccine in in adults ages 50 to 64 who are not considered at high risk of severe COVID, according to a news release by Novavax.
Nuvaxovid is a protein-based COVID vaccine that uses part of the virus made in a lab to teach your body how to fight it. It’s based on the Omicron JN.1 variant and helps your immune system make antibodies to protect you. The vaccine also has an ingredient from the soapbark tree that helps your body respond better. It’s given as one shot in the arm. If you’ve already had a COVID vaccine, you should wait at least two months before getting Nuvaxovid.
Common side effects of the vaccine across all age groups include pain or tenderness where the needle went in, feeling tired, muscle or joint pain, a headache, generally feeling unwell, and nausea or vomiting. Rare but serious side effects may include severe allergic reactions (anaphylaxis), myocarditis (inflammation of the heart muscle), and pericarditis (inflammation of the lining outside the heart). Fainting can sometimes happen after vaccines like Nuvaxovid, so it’s important to take precautions to avoid injury.
Before getting vaccinated, make sure to tell your doctor or the person giving the shot about any medical conditions you or your child may have. This includes having allergies, a history of a serious allergic reaction to a COVID vaccine, heart-related issues, fever, or bleeding problems. Also, let your doctor know if you’re taking blood thinners, have a weakened immune system, or are taking medications that affect your immune system. It is not known whether Nuvaxovid affects an unborn baby or passes through breast milk. Discuss with your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
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