FDA Approves Pfizer-BioNTech's Updated COVID-19 Vaccine For Older Adults, Those At-Risk

The FDA has approved the supplemental biologics license application (sBLA) for Pfizer and BioNTech's mRNA COVID-19 vaccine targeting the LP.8.1 sublineage of SARS-CoV-2 (Comirnaty), the virus that causes COVID-19, for use in adults aged 65 and older and in individuals aged 5 through 64 years with at least 1 underlying condition that puts them at high risk for severe COVID-19.¹

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Approval of the vaccine, announced in a news release from Pfizer and BioNTech, is supported by the vast body of evidence affirming its efficacy and safety. Pfizer-BioNTech's sBLA included preclinical data demonstrating the effectiveness of the LP.8.1-adapted vaccine against multiple sublineages of SARS-CoV-2, including NB.1.8.1 and XFG, compared with the company's previous COVID-19 vaccines.¹

The COVID-19 vaccines have continued to induce robust effectiveness since their development as they are reproduced to target new strains. With the FDA's recent recommendation that COVID-19 vaccines for the upcoming respiratory season be monovalent JN.1-lineage-based and target the LP.8.1 strain, Comirnaty is poised to be a key tool for pharmacists and health care professionals in protecting individuals from new COVID-19 strains.^1-3

Pfizer and BioNTech expressed confidence that their updated COVID-19 vaccines would be available for the upcoming respiratory season in numerous locations across the country and said that the vaccine could be shipped immediately.¹

Earlier in 2025, the FDA granted approval to 2 other COVID-19 vaccines with similar age group restrictions. Moderna's mRNA-1283 (mNEXSPIKE) was approved in June 2025 for adults aged 65 years and older and individuals aged 12 to 64 with an underlying condition. In May 2025, Nuvaxoid, Novavax's traditional, protein-based COVID-19 vaccine, was approved for the same age groups. Concurrently, Moderna's mRNA-1273 vaccine (Spikevax) was approved for children aged 6 months through 11 years in individuals at heightened risk of disease.^4-6

Collectively, these approvals are compliant with the stated intentions of FDA Commissioner Martin A. Makary, MD, MPH, who wrote in an editorial in the New England Journal of Medicine shortly after stepping into his position that, in future COVID-19 recommendations, adults aged 65 years and older and those with risk factors putting them at higher susceptibility for severe disease would be prioritized. For healthy individuals aged 6 months through 64 years, the FDA would request additional randomized trials to confirm the efficacy of the COVID-19 vaccines.^1,7

Although it is unknown at this time whether Pfizer-BioNTech was requested to complete another randomized study in healthy individuals, the companies noted in the news release that they had garnered substantial clinical trial data supporting approval of the vaccine for children aged 5 through 11 years.¹

In announcing the approval, Robert F. Kennedy Jr., secretary of the Department of Health and Human Services, also said that the emergency use authorizations, which were granted to the COVID-19 vaccines during the emergency phase of the COVID-19 pandemic and allowed for their use in individuals aged 6 months and older, had been revoked. Secretary Kennedy noted that FDA authorizations for Pfizer, Moderna, and Novavax's COVID-19 vaccines were approved for those considered at highest risk.^8,9

^REFERENCES

1. 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. News Release. Released August 27, 2025. Accessed August 27, 2025. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval

2. Halpern L. CDC-Led Study Affirms Robust Effectiveness of 2023-2024 COVID-19 Vaccines in Reducing Illness Severity, Mortality. Pharmacy Times. Published July 17, 2025. Accessed August 27, 2025. https://www.pharmacytimes.com/view/cdc-led-study-affirms-robust-effectiveness-of-2023-2024-covid-19-vaccines-in-reducing-illness-severity-mortality

3. Halpern L. FDA Recommends 2025-2026 COVID-19 Vaccines Be Monovalent, Target LP.8.1 Strain. Pharmacy Times. Published May 27, 2025. Accessed August 27, 2025. https://www.pharmacytimes.com/view/fda-recommends-2025-2026-covid-19-vaccines-be-monovalent-target-lp-8-1-strain

4. Halpern L. FDA Approves mRNA-1283 COVID-19 Vaccine for Adults 65 Years and Older, Those With Underlying Conditions. Pharmacy Times. Published June 2, 2025. Accessed August 27, 2025. https://www.pharmacytimes.com/view/fda-approves-mrna-1283-covid-19-vaccine-for-adults-65-and-older-those-with-underlying-conditions

5. Halpern L. FDA Approves Novavax COVID-19 Vaccine for Patients 65 Years and Older, Those With Underlying Conditions. Pharmacy Times. Published May 19, 2025. https://www.pharmacytimes.com/view/fda-approves-novavax-covid-19-vaccine-for-patients-65-years-and-older-those-with-underlying-conditions

6. Halpern L. FDA Grants Full Approval to mRNA-1273 COVID-19 Vaccine in Children at Increased Risk. Pharmacy Times. Published July 10, 2025. Accessed August 27, 2025. https://www.pharmacytimes.com/view/fda-grants-full-approval-to-mrna-1273-covid-19-vaccine-in-children-at-increased-risk

7. Halpern L. FDA to Restrict Future COVID-19 Vaccine Recommendations to Older Adults, High-Risk Groups. Pharmacy Times. Published May 21, 2025. Accessed August 27, 2025. https://www.pharmacytimes.com/view/fda-to-restrict-future-covid-19-vaccine-recommendations-to-older-adults-high-risk-groups

8. @SecKennedy on X. Published August 27, 2025, at 12:35 PM. Accessed August 27, 2025. https://x.com/SecKennedy/status/1960742897201872969

9. Lawrence L, Herper M. FDA issues narrower approvals for Covid boosters, revokes emergency authorizations. Stat. Published August 27, 2025. Accessed August 27, 2025. https://www.statnews.com/2025/08/27/fda-covid-vaccines-kennedy-rescinds-emergency-use-authorization/