The US Food and Drug Administration (FDA) has granted approval to Pfizer/BioNTech and Moderna for their respective supplemental biologics license applications for their updated mRNA COVID-19 vaccines, tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage. The companies announced the approvals late last month (August 22, 2024).  

The KP.2 adaptation is based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the US during the 2024-2025 fall and winter season. 

Pfizer/BioNTech received approval for its updated Comirnaty vaccine in individuals 12 years of age and older. The application also included manufacturing and non-clinical data showing that the KP.2-adapted vaccine generates an improved response against currently circulating Omicron JN.1 sublineages, including KP.2, KP.3 and LB.1, compared with the companies’ Omicron XBB.1.5 adapted COVID-19 vaccine. Pfizer reported that the company began shipping the vaccines, effective August 22, 2024.  

Pfizer’s/BioNTech’s updated COVID-19 vaccine also was granted emergency use authorization by FDA for individuals 6 months through 11 years of age. This season’s vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses. 

Moderna received FDA approval for its updated COVID-19 vaccine, Spikevax (2024-2025 formula) for individuals 12 years and above. FDA also granted emergency use authorization for Moderna’s COVID-19 Vaccine (2024-2025 formula) for individuals 6 months through 11 years of age. Moderna’s updated COVID-19 vaccine targets the KP.2 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. Moderna reported on August 22, 2024, that it would begin shipping the vaccines.  

Moderna reports that FDA’s decision was based on a combination of manufacturing and preclinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna’s COVID-19 mRNA vaccines. The updated vaccine composition is also based on guidance from FDA, which states that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2 composition. 

In other countries, regulators have recommended a vaccine that specifically targets the JN.1 variant, and Moderna reports that it is simultaneously manufacturing an updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. Additional regulatory applications for Moderna’s updated COVID-19 vaccines targeting KP.2 or JN.1 are under review by other regulatory agencies. Moderna reports that the European Medicines Agency’s Committee for Medicinal Products for Human Use has given a positive opinion regarding Moderna’s COVID-19 vaccine for approval with full European authorization under review.

Lastly, Novavax, a Gaithersburg, Maryland-based vaccines company, reported on August 30, 2024, that it has received FDA emergency use authorization for its protein-based COVID-19 vaccine for active immunization to prevent COVID-19 in individuals aged 12 and older. The company reported that its updated vaccine targets JN.1, the parent strain of currently circulating variants, and has shown cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1. The company reported on August 30, 2024, that prefilled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers, following the release of vaccine batches from FDA’s Center for Biologics Evaluation and Research.  

Source: Pfizer, Moderna (FDA Approval), Moderna (EMA Opinion) & Novavax