The U.S. Food and Drug Administration (FDA) has approved Pfizer and BioNTech’s Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine for individuals 12 years and older. It has also granted emergency use authorization for children aged 6 months to 11 years.
This season’s vaccine will be a single dose for those 5 years and older. Immunocompromised individuals 5 years and older may be eligible for additional doses. The vaccine targets the KP.2 sublineage of the Omicron variant, as recommended by the FDA.
The approval is supported by extensive clinical, non-clinical, and real-world evidence demonstrating the safety and effectiveness of Pfizer and BioNTech’s COVID-19 vaccines. The KP.2-adapted vaccine has shown an improved response against circulating Omicron sublineages, including KP.2, KP.3, and LB.1, compared to the previous XBB.1.5-adapted vaccine.
Staying up to date with vaccinations remains crucial, especially as COVID-19 cases rise. The 2024-2025 Formula vaccine will be available in pharmacies, hospitals, and clinics across the U.S.
Pfizer and BioNTech’s COVID-19 vaccines are based on proprietary mRNA technology and have received Marketing Authorization in the U.S., EU, UK, and other countries. They also hold emergency use authorizations or equivalents in multiple countries.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
