Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has approved their supplemental Biologics License Application for the Comirnaty Covid-19 Vaccine (mRNA) for individuals aged 12 and older.
Additionally, the FDA has granted emergency use authorisation (EUA) for Pfizer-BioNTech’s Omicron KP.2-adapted 2024-2025 Formula Covid-19 vaccine for children aged six months to 11 years.
The health agency also authorised Spikevax for individuals 12 years of age and older and Moderna Covid-19 Vaccine for emergency use in individuals six months through 11 years of age.
This season’s vaccine is intended as a single dose for most people aged five and older.
In addition, those aged five and older with specific types of immunocompromise who have previously received the vaccines, as well as children under five who have not completed a three-dose series are also eligible for additional doses.
The KP.2 adaptation of the Covid-19 vaccine is based on FDA guidance, which recommended KP.2 as the preferred strain from the JN.1 lineage for Covid-19 vaccines for use in the US during the 2024-2025 fall and winter season, if feasible.
The Pfizer and BioNTech Covid-19 vaccine for this season will start shipping immediately and will be available in pharmacies, hospitals, and clinics across the US in the coming days.
FDA’s Center for Biologics Evaluation and Research director Peter Marks said: “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.
“Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated Covid-19 vaccine to provide better protection against currently circulating variants.”
The approval is based on clinical, non-clinical, and real-world evidence demonstrating the safety and effectiveness of Pfizer and BioNTech’s Covid-19 vaccines.
The application also included data showing that the KP.2-adapted vaccine produces a significantly improved immune response against currently circulating Omicron JN.1 sublineages, such as KP.2, KP.3, and LB.1, compared to the previous Omicron XBB.1.5-adapted vaccine.
Pfizer and BioNTech’s Covid-19 vaccines use BioNTech’s proprietary mRNA technology and were developed collaboratively by both companies.
BioNTech is the marketing authorisation holder for Comirnaty and its various adapted versions in the US, the European Union, the UK, and other countries and holds emergency use authorisation in several regions.
