Pfizer Inc. and BioNTech SE announced on May 28, 2025, that they have submitted a regulatory application to the European Medicines Agency (EMA) for approval of COMIRNATY for the 2025-2026 season, targeting the LP.8.1 strain. The submission follows the recommendation by the EMA's Emergency Task Force (ETF) to update the COVID-19 vaccine composition for the coming season to target the LP.8.1 strain.
Regulatory Strategy and Current Authorization Status
The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. BioNTech serves as the Marketing Authorization Holder for COMIRNATY and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and holds emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
COMIRNATY has been granted standard marketing authorization by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The vaccine is administered as a single dose in people 5 years of age and older, and as a three-dose series in infants and children from 6 months to 4 years who have not had COVID-19, with the first two doses given three weeks apart, followed by a third dose given at least 8 weeks after the second dose.
Dosing and Administration Guidelines
The current dosing regimen varies by age group: adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose; infants and children aged 6 months to 4 years are given 3 micrograms per dose. Additional doses may be administered to individuals aged 5 years and older who are severely immunocompromised in accordance with national recommendations.
Existing Variant-Adapted Vaccines
COMIRNATY has also been granted standard marketing authorization for three adapted vaccines: COMIRNATY Omicron XBB.1.5, which contains mRNA encoding for the spike protein of the Omicron XBB.1.5 subvariant of SARS-CoV-2; COMIRNATY JN.1, which contains mRNA encoding for the spike protein of the Omicron JN.1 subvariant of SARS-CoV-2; and COMIRNATY KP.2, which contains mRNA encoding for the spike protein of the Omicron KP.2 subvariant of SARS-CoV-2.
These adapted vaccines may be administered as a single dose regardless of prior vaccination status in people aged 5 years and older. Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19. There should be an interval of at least 3 months between administration of these adapted vaccines and the last prior dose of a COVID-19 vaccine.
Regulatory Evaluation Process
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are available. However, neither company has disclosed any information regarding which age groups the updated LP.8.1-targeting vaccine will target, nor mentioned if any clinical studies will be conducted for it.
