EU's CHMP endorses Pfizer-BioNTech's modified LP.8.1 COVID-19 vaccine for approval
Updated Pfizer-BioNTech COVID-19 Vaccine Targets Dominant Variant for 2025-2026 Season
The Pfizer-BioNTech COVID-19 Vaccine has been updated for the 2025-2026 season to specifically target the LP.8.1 variant of SARS-CoV-2, the dominant strain for this period. The updated vaccine, known as the LP.8.1-adapted monovalent COVID-19 vaccine, has been authorized for active immunization in individuals aged 6 months and older.
The LP.8.1-adapted vaccine elicits an improved immune response against multiple currently dominant and emerging SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and LF.7. This improved response is compared to earlier variant-adapted vaccines such as those targeting the JN.1 and KP.2 variants.
| Vaccine Formulation | Target Variant | Immune Response Profile | |---------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------| | LP.8.1-adapted vaccine (Pfizer, Moderna) | LP.8.1 variant (2025-2026 dominant) | Improved immune response against dominant and emerging sublineages XFG, NB.1.8.1, LF.7, surpassing prior JN.1 and KP.2 adaptations. | | Prior variant-adapted vaccines | JN.1, KP.2 variants | Effective against their target variants but comparatively less broad/improved immune responses against current sublineages. |
The decision to update the vaccine formulation to LP.8.1 by the European Medicines Agency’s Emergency Task Force is based on evidence indicating that targeting LP.8.1 will help maintain vaccine effectiveness as the virus evolves.
It is important to note that the Pfizer-BioNTech COVID-19 Vaccine, like all vaccines, may not protect everyone. People with weakened immune systems may have a reduced immune response to the vaccine. Additionally, severe allergic reactions to the vaccine are rare but can occur. Symptoms of a severe allergic reaction include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, or dizziness and weakness.
If your child experiences chest pain, shortness of breath or difficulty breathing, feelings of having a fast-beating, fluttering, or pounding heart, or any of the other symptoms listed after receiving the Pfizer-BioNTech COVID-19 Vaccine, particularly during the 2 weeks after receiving a dose of the vaccine, seek medical attention right away.
Before receiving the Pfizer-BioNTech COVID-19 Vaccine, it is crucial to tell your vaccination provider about all of your child's medical conditions. The vaccine should not be given to children who have had a severe allergic reaction to a previous dose of the vaccine or its ingredients.
The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. Individuals can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including the Pfizer-BioNTech COVID-19 Vaccine. These conditions most commonly occur in males 12 years through 24 years of age.
In conclusion, the LP.8.1-adapted vaccine formulations for the 2025-2026 season are specifically designed to provide better protection against the latest circulating SARS-CoV-2 sublineages—including XFG and NB.1.8.1—reflecting the evolution of the virus and thereby maintaining or enhancing vaccine effectiveness.
Upon authorization by the European Commission (EC), the LP.8.1-adapted COVID-19 vaccine will be available for individuals 6 months of age and older. Pfizer Inc. and BioNTech SE have already initiated manufacturing of the LP.8.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season. Report vaccine side effects to the US 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 to
The updated Pfizer-BioNTech COVID-19 Vaccine, specifically the LP.8.1-adapted monovalent vaccine, is designed to provide an improved immune response against multiple medical-conditions such as XFG, NB.1.8.1, and LF.7, and it surpasses the earlier variant-adapted vaccines' immune response profiles like those targeting the JN.1 and KP.2 variants. In the field of health-and-wellness, it is essential to note that while the vaccine offers enhanced protection against the latest SARS-CoV-2 sublineages, it may not protect everyone, and people with certain medical-conditions might have a reduced immune response to the vaccine.
