Pfizer Inc. and BioNTech SE announced that the U.S. FDA has approved their supplemental Biologics License Application for the Omicron KP.2-adapted COVID-19 vaccine (COMIRNATY®) for individuals aged 12 and older. The vaccine has also received emergency use authorization for individuals aged 6 months to 11 years. This new formulation is intended for the 2024-2025 season and can be administered as a single dose for most people aged 5 and older. Immunocompromised individuals and certain younger children may be eligible for additional doses.
The KP.2 adaptation follows FDA guidance, which recommends this strain for the upcoming fall and winter season. The vaccine will be available in pharmacies, hospitals, and clinics across the U.S. within days.
Approval was based on extensive clinical, non-clinical, and real-world data demonstrating the vaccine’s safety and effectiveness. The KP.2-adapted vaccine offers an improved immune response against current Omicron sublineages, including KP.2, KP.3, and LB.1, compared to the previous Omicron XBB.1.5 version.
The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s mRNA technology. BioNTech holds the Marketing Authorization for COMIRNATY® and its variants in the U.S., EU, UK, and other regions, as well as emergency use authorizations in the U.S. and elsewhere.
Indication and Safety Information:
COMIRNATY® is approved for individuals aged 12 and older to protect against COVID-19. It should not be administered to those who have had a severe allergic reaction to a previous dose or any ingredient in the vaccine. Rare cases of myocarditis and pericarditis have been reported, primarily in adolescent males. Other side effects may include non-severe allergic reactions, injection site pain, tiredness, headache, and more.
For additional information, including how to report side effects, please refer to the full prescribing and patient information available through Pfizer.
