The Medical Letter on Drugs and Therapeutics
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COVID-19 Update: Full Approval for Novavax COVID-19 Vaccine
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Med Lett Drugs Ther. 2025 Jun 2;67(5109):1   doi:10.58347/tml.2025.5109a
Disclosures
Objective(s)

Nuvaxovid, the adjuvanted protein subunit COVID-19 vaccine marketed by Novavax, has received full approval from the FDA to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all adults ≥65 years old and in adults 12-64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The vaccine was previously available under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based COVID-19 vaccine to receive full approval from the FDA; the mRNA COVID-19 vaccines Comirnaty and Spikevax are approved for use in patients ≥12 years old.

FORMULATION – The 2024-2025 formulation of Nuvaxovid contained the spike protein of the JN.1 Omicron strain of SARS-CoV-2. The Vaccines and Related Biological Products Advisory Committee has recommended that the same JN.1 lineage (preferentially the LP.8.1 strain) be used in the 2025-2026 COVID-19 vaccines.2

DOSAGE – Persons receiving Nuvaxovid who have not been vaccinated against COVID-19 previously should receive two 0.5 mL doses 3-8 weeks apart. Those who have been vaccinated against COVID-19 previously should receive a single 0.5-mL dose ≥2 months after their last COVID-19 vaccine dose.

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