09/02/2025
FDA Authorizes Updated COVID Vaccines with Limitations
The U.S. Food and Drug Administration (FDA) has authorized the use of updated 2025-2026 COVID vaccines for Pfizer-BioNTech, Moderna, and Novavax, with restrictions for certain age groups and conditions. The updated 2025-2026 COVID vaccine targets the LP.8.1 strain, an offshoot of the JN.1 subvariant. The LP.8.1 strain closely matches the circulating strains that have been predominant in the United States and other regions since the beginning of 2025.
The updated 2025-2026 COVID vaccines are approved for patients aged 65 years and older. For individuals under the age of 65, the FDA has restricted the authorization of the updated 2025-2026 COVID vaccines to only include patients with at least one underlying condition that puts them at high risk for severe COVID-19.
In addition to the updated COVID vaccine approval, the FDA revoked the Emergency Use Authorization (EUA) for the COVID-19 vaccines for healthy children 11 years old and younger. The COVID-19 vaccines whose EUA has been revoked are Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, and Novavax COVID-19 Vaccine, Adjuvanted.
The currently FDA-approved COVID-19 vaccines for the 2025-2026 COVID-19 vaccine season are Comirnaty (COVID-19 Vaccine, mRNA), Mnexspike (COVID-19 Vaccine, mRNA), Nuvaxovid (COVID-19 Vaccine, Adjuvanted), and Spikevax (COVID-19 Vaccine, mRNA).
View the news release here:
The Food and Drug Administration rescinded the emergency use authorization that made COVID-19 shots available for healthy children under 5 years old.