Silver Spring, Md. – August 27, 2025 – The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Pfizer/BioNTech, Moderna, and Novavax for the 2025–2026 season, ensuring continued protection against evolving variants of the coronavirus.

The approvals cover Pfizer’s Comirnaty, Moderna’s Spikevax and MNEXSPIKE, and Novavax’s Nuvaxovid, each incorporating revised formulations and labeling updates. The vaccines will be available for high-risk populations, older adults, and in some cases, younger children with underlying conditions.

Pfizer/BioNTech – Comirnaty

Pfizer and BioNTech received approval for two updated doses:

  • A 10 mcg formulation for children aged 5–11 with medical conditions that raise their risk of severe COVID-19.
  • A 30 mcg prefilled syringe for people 65 and older, and for 12–64-year-olds with at least one high-risk condition.

The FDA also confirmed that Pfizer has fulfilled certain deferred pediatric study requirements, strengthening evidence for the vaccine’s safety in younger age groups.

Moderna – Spikevax and MNEXSPIKE

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Moderna secured two approvals:

  • Spikevax, manufactured in European facilities, will roll out with the 2025–2026 formula.
  • MNEXSPIKE, another mRNA-based vaccine, was cleared for adults 65+ and those 12–64 at higher risk.

Both vaccines will undergo further postmarketing studies to assess safety, immune response, and effectiveness against emerging variants.

Novavax – Nuvaxovid

Novavax’s protein-based vaccine, Nuvaxovid, also received the FDA’s green light for its updated formula, produced at the Serum Institute of India. Post-approval commitments include clinical trials to evaluate responses to the Omicron JN.1 subvariant and studies on long COVID symptoms.

Oversight and Monitoring

All manufacturers are required to submit final product labeling in the FDA’s electronic format and adhere to strict promotional guidelines. In addition, each company must complete ongoing postmarketing trials through 2026–2028 to track safety, variant effectiveness, and potential long-term effects.

With these approvals, the FDA aims to maintain strong defenses against COVID-19 as the virus continues to evolve. Similar to annual influenza updates, the 2025–2026 vaccines will play a central role in fall and winter vaccination campaigns, especially for vulnerable groups.

Source: FDA Press Release