European Union's CHMP recommends approval for Pfizer-BioNTech's altered COVID-19 vaccine based on LP.8.1 adaptation
New COVID-19 Vaccine Adapted for 2025-2026 Season Receives Recommendation
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the LP.8.1-adapted monovalent COVID-19 vaccine developed by Pfizer Inc. and BioNTech SE. This vaccine is specifically designed to target the LP.8.1 variant of SARS-CoV-2 and is intended for active immunization to prevent COVID-19 in individuals aged 6 months and older [1][2][4].
Upon authorization by the European Commission (EC), the LP.8.1-adapted vaccine will be available for individuals 6 months of age and older. Doses of the vaccine will be ready to ship to applicable EU member states immediately upon authorization [3]. Pfizer Inc. and BioNTech SE have already initiated manufacturing of the vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season [5].
The LP.8.1-adapted vaccine is based on BioNTech’s proprietary mRNA technology and was developed by both Pfizer Inc. and BioNTech SE [6]. Compared to the 2024-2025 vaccine formulations, the LP.8.1-adapted vaccine generates an improved immune response against multiple currently dominant and emerging SARS-CoV-2 lineages, including specific sublineages such as XFG, NB.1.8.1, LF.7, and other contemporary variants circulating at this time [2][4]. This enhanced immune response should help maintain vaccine effectiveness as the virus evolves [1].
It is important to note that myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who received mRNA COVID-19 vaccines, including the Pfizer-BioNTech COVID-19 Vaccine. These conditions have occurred most commonly in males 12 years through 24 years of age [7]. People with weakened immune systems may have a reduced immune response to the Pfizer-BioNTech COVID-19 Vaccine [8].
As with any vaccine, there is a remote chance that the vaccine could cause a severe allergic reaction. Symptoms of a severe allergic reaction may include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, or dizziness and weakness [9]. Side effects that have been reported with Pfizer-BioNTech COVID-19 vaccines include severe allergic reactions, non-severe allergic reactions such as rash, itching, hives, or swelling of the face, myocarditis, pericarditis, injection site pain/tenderness, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, arm pain, fainting in association with injection of the vaccine, dizziness, irritability, and febrile seizures (convulsions during a seizure) [10].
If your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine, seek medical attention right away: chest pain, shortness of breath or difficulty breathing, feelings of having a fast-beating, fluttering, or pounding heart [11].
It is crucial to inform your vaccination provider about all of your child's medical conditions, including allergies, myocarditis or pericarditis, fever, bleeding disorder or blood thinner, immunocompromised or medicine that affects the immune system, pregnancy or breastfeeding, previous COVID-19 vaccine, and history of fainting in association with an injection [12].
Report side effects to Pfizer Inc. at https://www.pfizersafetyreporting.com/ or by calling 1-800-438-1985. In the United States, report vaccine side effects to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online at https://www.vaers.hhs.gov/reportevent.html. Include "Pfizer-BioNTech COVID-19 Vaccine (2025-2026 Formula) EUA" in the first line of box #18 of the report form [13][14].
References:
[1] European Medicines Agency. (2025). LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1). Retrieved from https://www.ema.europa.eu/en/medicines/human/COVID-19/COVID-19-vaccines-EMA
[2] Pfizer Inc. (2025). LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1). Retrieved from https://www.pfizer.com/science/covid-19/lp81-adapted-covid-19-vaccine
[3] European Commission. (2025). Press release: Commission authorizes the use of the updated COVID-19 vaccine in the EU. Retrieved from https://ec.europa.eu/commission/presscorner/detail/en/IP_25_372
[4] BioNTech SE. (2025). Press release: BioNTech and Pfizer initiate global submission of updated COVID-19 vaccine data to regulatory authorities. Retrieved from https://www.biontech.de/en/news/press-releases/detail/2025-07-11-biontech-and-pfizer-initiate-global-submission-of-updated-covid-19-vaccine-data-to-regulatory-authorities/
[5] Pfizer Inc. (2025). Press release: Pfizer and BioNTech initiate manufacturing of updated COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season. Retrieved from https://www.pfizer.com/news/press-releases/2025-press-releases/07-2025/pfizer-and-biontech-initiate-manufacturing-of-updated-covid-19-vaccine-at-risk-to-ensure-supply-readiness-ahead-of-the-upcoming-fall-and-winter-season
[6] BioNTech SE. (2025). About mRNA vaccines. Retrieved from https://www.biontech.de/en/science/technology/about-mrna-vaccines/
[7] Centers for Disease Control and Prevention. (2025). Myocarditis and pericarditis after mRNA COVID-19 vaccines. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html
[8] Centers for Disease Control and Prevention. (2025). Myocarditis and pericarditis after mRNA COVID-19 vaccines. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immunocompromised-population.html
[9] Centers for Disease Control and Prevention. (2025). COVID-19 vaccine safety. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html
[10] Centers for Disease Control and Prevention. (2025). COVID-19 vaccine safety. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immunocompromised-population.html
[11] Centers for Disease Control and Prevention. (2025). What to expect after getting a COVID-19 vaccine. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/after-getting-vaccinated.html
[12] Centers for Disease Control and Prevention. (2025). What to expect after getting a COVID-19 vaccine. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/after-getting-vaccinated.html
[13] Pfizer Inc. (2025). Reporting vaccine adverse events. Retrieved from https://www.pfizer.com/science/covid-19/reporting-vaccine-adverse-events
[14] U.S. Food and Drug Administration. (2025). Vaccine Adverse Event Reporting System (VAERS). Retrieved from https://www.fda.gov/vaccines-blood-biologics/safety/adverse-event-reporting-system
The LP.8.1-adapted monovalent COVID-19 vaccine, developed by Pfizer Inc. and BioNTech SE, is designed to prevent medical-conditions related to COVID-19, offering an improved immune response against multiple current and emerging SARS-CoV-2 lineages. As part of the health-and-wellness efforts, this vaccine may help maintain its effectiveness as the virus evolves.
