FDA Approves Updated 2025-2026 COVID-19 Vaccine for Patients 65 Years and Older

The FDA approved a supplemental biologics license application for Comirnaty, Pfizer and BioNTech’s LP.8.1-adapted monovalent COVID-19 vaccine. The updated 2025-2026 formulation is indicated for patients 65 years and older as well as patients aged 5 through 64 years with at least 1 underlying condition associated with a high risk of severe outcomes from COVID-19.¹

“Generally, the fall and winter months is when we see a spike in respiratory illnesses, such as the flu, COVID-19 and RSV [respiratory syncytial virus],” Timothy Hudd, PharmD, RPh, AE-C, professor of pharmacy Practice at Massachusetts College of Pharmacy and Health Sciences, said.² “Now is a good time to prepare in advance by ensuring ample stock of not only vaccine supply, but other resources in the armamentarium, such as antivirals and even OTC products such as antipyretics and protective gear like masks and hand sanitizer.”

On May 22, 2025, the FDA voted to recommend monovalent vaccine composition for the J.1-lineage. Following the vote, the committee then discussed considerations for the selection of JN.1 and specific lineage strains for the 2025-2026 COVID-19 vaccine formulation. Based on the evidence, the FDA recommended manufacturers should use the LP.8.1 strain as part of the fall 2025 vaccinations.³

The approval was based on evidence that supports the safety and efficacy of the vaccine, including data for children 5 through 11 years. The data showed that the LP.8.1 monovalent COVID-19 vaccine improved immune responses against multiple SARS-CoV-2 sublineages compared with the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines.¹

In that study (NCT07069309), investigators aimed to determine the safety, tolerability, and immunogenicity of the updated vaccine for patients 18 to 64 years old who were considered high risk for severe disease from COVID-19 and patients 65 years of age and older. Patients visited the clinical study site at least 4 times over 6 months. The primary outcomes included percentage of individuals reporting local reactions (up to 7 days), systemic events (up to 7 days), adverse events (through 1 month), and serious AEs (through 6 months), as well as geometric mean titers, geometric mean fold rises, and percentage of patients with seroresponse at 2 weeks after vaccination.

The secondary end points included geometric mean titers, geometric mean fold rises, and percentage of patients with seroresponse at 1 month after vaccination.⁴

This approval follows the American Academy of Pediatrics, which published an immunization schedule covering updated guidance for influenza, RSV, and COVID-19 for patients from birth to 18 years. Although these recommendations follow tradition, the schedule differs from the recent recommendations from the CDC’s Advisory Committee on Immunization Practices.⁵

READ MORE: Immunization Resource Center

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REFERENCES

1. Pfizer and BioNTech’s Comirnaty received US FDA approval for adults 65 and older and individuals ages 5 through 64 at increased risk for severe COVID-19. News release. Pfizer. August 27, 2025. Accessed August 27, 2025. https://www.businesswire.com/news/home/20250822994391/en/Pfizer-and-BioNTechs-COMIRNATY-Receives-U.S.-FDA-Approval-for-Adults-65-and-Older-and-Individuals-Ages-5-through-64-at-Increased-Risk-for-Severe-COVID-19

2. Meara K, Hudd T. Q&A: preparing community pharmacies for respiratory disease season. Drug Topics. August 18, 2025. Accessed August 27, 2025. https://www.drugtopics.com/view/q-a-preparing-community-pharmacies-for-respiratory-disease-season

3. FDA. COVID-19 vaccines (2025-2026 formula) for use in the United States beginning in fall 2025. Updated May 22, 2025. Accessed August 27, 2025. https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025

4. A study to learn about COVID-19 RNA-based variant-adapted vaccine candidate(s) against SARS-CoV-2 in adults, including those at higher risk of severe COVID-19. ClinicalTrials.gov identification: NCT07069309. Updated August 3, 2025. Accessed August 27, 2025. https://www.clinicaltrials.gov/study/NCT07069309

5. The American Academy of Pediatrics releases its own evidence-based immunization schedule. News release. American Academy of Pediatrics. August 19, 2025. Accessed August 27, 2025. https://www.aap.org/en/news-room/news-releases/aap/2025/the-american-academy-of-pediatrics-releases-its-own-evidence-based-immunization-schedule/