On Wednesday, Aug. 27, the FDA approved the 2025-2026 formulas from both companies, each tailored to target the LP.8.1 sublineage — a new offshoot of the JN.1 variant — aligning the vaccines with the strains currently circulating in the US. 

By Joe Lombardi From Daily Voice

As fall approaches, the Food and Drug Administration has authorized updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna, but with access limited to those most at risk for severe illness.

On Wednesday, Aug. 27, the FDA approved the 2025-2026 formulas from both companies, each tailored to target the LP.8.1 sublineage — a new offshoot of the JN.1 Omicron variant — aligning the vaccines with the strains currently circulating in the US. 

Pfizer-BioNTech’s COMIRNATY LP.8.1 is approved for adults 65 and older, as well as individuals ages 5 to 64 with at least one underlying health condition that increases their risk for serious COVID-19 complications.

Moderna’s updated Spikevax vaccine is available for adults 65 and older, and for people ages 6 months through 64 years with at least one qualifying health condition.

Additionally, Moderna’s new mNEXSPIKE vaccine has been approved for adults 65 and older, and for individuals ages 12 to 64 in high-risk groups.

A list of higher-risk groups is provided on the Centers for Disease Control and Prevention website here.

"The emergency use authorizations for COVID vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded," Secretary of Health and Human Services Robert F. Kennedy Jr. said on social media.

"These vaccines are available for all patients who choose them after consulting with their doctors.

"The American people demanded science, safety, and common sense. This framework delivers all three."

Both companies announced that shipments of the updated vaccines will begin immediately, with doses expected to reach pharmacies, hospitals, and clinics across the country in the coming days. 

The FDA’s decision aims to provide the strongest protection to those who need it most as the virus continues to evolve.

Health officials advise eligible individuals to speak with their healthcare provider about vaccination and potential side effects, including rare allergic or cardiac reactions.