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Nuvaxovid 2026–2027 Formula — 5 mcg/0.5 mL Pre-Filled Syringes, 10/Carton

NDC/Item Number: 49281002650
Manufacturer:
NOVAVAX
Form
PFS
Unit size
5MCG
Strength
0.5ML

Details

Details

NUVAXOVID (COVID-19 Vaccine, Adjuvanted), 2026–2027 Formula

NUVAXOVID is an FDA-approved recombinant protein vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2. Under the current prescribing information, it is approved for individuals 65 years of age and older and for individuals 12 through 64 years of age with at least one underlying condition that places them at high risk for severe COVID-19 outcomes.

The 2026–2027 Formula is a sterile injectable suspension formulated with recombinant spike glycoprotein from the SARS-CoV-2 JN.1-descendent variant XFG and Matrix-M adjuvant. It is supplied in ready-to-use, single-dose pre-filled syringes for intramuscular administration.

  • Brand: NUVAXOVID
  • Proper name: COVID-19 Vaccine, Adjuvanted
  • Formula: 2026–2027
  • Antigen: 5 mcg recombinant spike glycoprotein from the JN.1-descendent XFG variant per 0.5 mL dose
  • Adjuvant: 50 mcg Matrix-M per 0.5 mL dose
  • Dosage form: Sterile injectable suspension
  • Route: Intramuscular use
  • Package presentation: 10 single-dose, 0.5 mL pre-filled syringes per carton
  • Carton NDC: 49281-026-50
  • Single-syringe NDC: 49281-026-88
  • Manufacturer: Sanofi Vaccines US Inc.
  • Brand owner: NUVAXOVID is a trademark of Novavax, Inc.
  • Status: Prescription vaccine
  • Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.

Important safety information: Do not administer NUVAXOVID to individuals with a known history of severe allergic reaction, including anaphylaxis, to any component of the vaccine or following a previous dose of a Novavax COVID-19 vaccine. Appropriate medical treatment must be immediately available to manage a possible acute allergic reaction. Clinical-trial and postmarketing data include reports of myocarditis and pericarditis. Syncope may occur with injectable vaccines, and vaccination may not protect every recipient.

For licensed healthcare professionals and qualified purchasers. Refer to the current FDA-approved prescribing information for complete indications, preparation and administration instructions, contraindications, warnings, precautions, adverse reactions, and storage requirements.