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FDA approves updated COVID-19 vaccines from Pfizer and Moderna for older adults and high-risk groups

August 27, 2025

On August 27, 2025, FDA approved Pfizer’s Comirnaty LP.8.1 for use in adults ≥65 years of age, and individuals aged 5 to 64 years with ≥1 condition that increases their risk for severe COVID-19.

The agency also approved Moderna’s Spikevax LP.8.1 for individuals 6 months through 64 years of age with ≥1 underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults ≥65 years of age.

mNexspike, Moderna's new COVID-19 vaccine, is approved for individuals 12 to 64 years of age with ≥1 underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults ≥65 years of age.

Concurrent with the new approvals, FDA rescinded prior emergency use authorizations for COVID vaccines, one of which allowed for use of the Pfizer product in children ages 6 months to 4 years.

These approvals reflect a shift toward risk-based vaccination strategies, focusing on populations most vulnerable to severe disease. Clinical and preclinical data showed improved immune responses against circulating variants, including XFG and NB.1.8.1. Both companies emphasized the importance of protecting high-risk individuals, citing millions of outpatient visits and hundreds of thousands of hospitalizations due to COVID-19 in the past year.

The vaccines are expected to be available in pharmacies and clinics within days, offering tailored protection ahead of the 2025–2026 respiratory season.

Sources:

(2025, August 27). Pfizer. Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19. [Press release]. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval

(2025, August 27). Moderna. Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2. [Press release]. https://feeds.issuerdirect.com/news-release.html?newsid=6729249760870595&symbol=MRNA