TM Owner Sanofi
Nuvaxovid 5mcg/0.5mL Injection
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Indications & Clinical Uses
- Nuvaxovid (COVID-19 Vaccine, Adjuvanted) is a protein-based vaccine containing recombinant SARS-CoV-2 spike protein combined with the Matrix-M adjuvant to boost the immune response.
- It is FDA-approved in the United States for active immunisation against COVID-19 in people 65 years of age and older, and in people 12 through 64 years of age who have at least one underlying medical condition that increases the risk of severe COVID-19; in the European Union it is authorised more broadly, for everyone aged 12 years and older regardless of risk factors, so eligibility differs by market.
- It is given as a single 0.5 mL dose by intramuscular injection, at least two months after any previous COVID-19 vaccine dose, and the strain composition is updated periodically to match circulating variants.
- Novavax originally developed and marketed Nuvaxovid; full US and EU marketing authorisation transferred to Sanofi in October-November 2025, so Sanofi is now the responsible manufacturer/marketing-authorisation holder for this brand.
- Nuvaxovid is given by a healthcare provider, not self-administered.
Side Effects
- The most commonly reported side effects of Nuvaxovid, affecting more than 1 in 10 people, are pain and tenderness at the injection site, headache, fatigue, muscle pain, malaise, joint pain, and nausea or vomiting; these usually start within a day or two and resolve within a few days.
- Nuvaxovid carries no boxed warning, but the label includes a specific warning about myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart), observed most often in younger males within about ten days of a dose — seek urgent medical attention for new chest pain, shortness of breath, or a fast or pounding heartbeat after vaccination.
- Severe allergic reactions, including anaphylaxis, can occur, which is why vaccination is given where appropriate monitoring and emergency treatment are available for at least 15 minutes afterwards.
- Fever, chills and swollen lymph nodes near the injection arm have also been reported.
Precautions & Warnings
- Do not receive Nuvaxovid if you have had a severe allergic reaction, including anaphylaxis, to any component of this vaccine or to a previous dose of any Novavax COVID-19 vaccine.
- Tell your healthcare provider about any history of myocarditis or pericarditis, as increased risk has been observed with this vaccine, particularly in adolescent and young adult males; symptoms occurring after vaccination should be reported promptly.
- People with a bleeding disorder or on blood thinners should mention this before the injection, as pressure may need to be applied afterwards.
- Nuvaxovid has not been specifically contraindicated in pregnancy or breastfeeding, but discuss the timing and benefits with your healthcare provider if you are pregnant, breastfeeding, or trying to conceive.
- The vaccine should be given intramuscularly only, never intravenously or subcutaneously.
- Vials are stored refrigerated at 2°C to 8°C, protected from light, and must not be frozen; discard any vial that has been frozen.
Avoid Interactions
- Tell your healthcare provider about all vaccines and medicines you have recently received or are taking, since Nuvaxovid has not been specifically studied for interactions with other vaccines given at the same visit, and current guidance generally recommends spacing other vaccines a short interval apart from Nuvaxovid where practical.
- People taking medicines or with conditions that suppress the immune system, such as chemotherapy, high-dose steroids, or biologic therapies, may have a reduced immune response to vaccination and should discuss timing with their healthcare provider.
- There is no known interaction with alcohol, food or grapefruit.
- If you have had a reaction, including myocarditis or pericarditis, after any previous COVID-19 vaccine, tell the person vaccinating you before receiving Nuvaxovid.
- Always tell your healthcare provider about all prescription and over-the-counter medicines, herbal products and supplements you take, and about any bleeding disorder, before your appointment.
References
Frequently Asked Questions
Nuvaxovid is a protein-based COVID-19 vaccine containing SARS-CoV-2 spike protein with the Matrix-M adjuvant. In the US it's approved for people 65 and older, and ages 12-64 with an underlying condition raising COVID-19 risk; the EU authorises it more broadly from age 12 up.
Nuvaxovid is given as a single 0.5 mL injection into the muscle of the upper arm by a healthcare provider. If you've had a COVID-19 vaccine before, Nuvaxovid is given at least two months after that dose. It is not self-administered.
More than 1 in 10 people get injection-site pain, headache, fatigue, muscle and joint pain, or nausea, usually resolving within days. Nuvaxovid can rarely cause myocarditis or pericarditis, most often in younger males — get urgent care for chest pain, breathlessness or a racing heartbeat after vaccination.
Avoid Nuvaxovid if you've had a severe allergic reaction to it or any Novavax COVID-19 vaccine before. Tell your provider if you have a history of myocarditis or pericarditis, or take medicines that weaken your immune system, since these can affect the vaccine's safety.
Novavax originally developed Nuvaxovid, but full US and EU marketing rights transferred to Sanofi in October-November 2025. Sanofi is now the responsible manufacturer and marketing-authorisation holder, though the vaccine itself — its formula and Matrix-M adjuvant — is unchanged.
In the US, Nuvaxovid is approved from age 12 only in those with an underlying condition raising COVID-19 risk, or for anyone 65 and older; it is not approved under age 12. The EU authorises it for everyone aged 12 and above without that restriction.
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