NUVAXOVID™ (COVID-19 Vaccine, Adjuvanted 2025-2026 Formula)

NUVAXOVID™ (COVID-19 Vaccine, Adjuvanted) injectable suspension, for intramuscular use
2025-2026 Formula
Initial U.S. Approval: 2025

INDICATIONS AND USAGE

NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

NUVAXOVID is approved for use in individuals who are:

• 65 years of age and older, or
• 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (1)

DOSAGE AND ADMINISTRATION

• For intramuscular use (2).
• Administer NUVAXOVID as a single 0.5 mL dose (2.1).
• For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of NUVAXOVID at least 2 months after the last dose (2.1).

DOSAGE FORMS AND STRENGTHS

NUVAXOVID is an injectable suspension. A single dose is 0.5 mL (3).

CONTRAINDICATIONS

Do not administer NUVAXOVID to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of NUVAXOVID or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Novavax COVID-19 Vaccine, Adjuvanted (4).

WARNINGS AND PRECAUTIONS

Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of NUVAXOVID. There have been postmarketing reports of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted (5.2).