On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above.  Emergency Use Authorization (“EUA”) was also granted for the updated vaccine for individuals aged 6 months to 11 years old.  According to Moderna, the updated vaccine targets the KP.2 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older.   According to the announcement, Moderna’s updated vaccine is based on FDA guidance specifying that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2 composition.  Moderna’s CEO, Stéphane Bancel, noted that “COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition. In the 2023-24 season, we saw more than 600,000 hospitalizations due to COVID in the U.S.”

On the same day, Pfizer and BioNTech also announced that they received approval for their sBLA for an updated composition of their Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine, COMIRNATY ®, for individuals 12 years old and above, as well as EUA for individuals aged 6 months to 11 years old.  According to the announcement, the vaccine is for use as a single dose for most individuals aged 5 and older, with eligibility for additional doses for individuals with certain kinds of immunocompromise and for those under age 5 who have not already completed a three-dose series with previous vaccine formulas.

Approval of both vaccines was based on previous clinical, non-clinical and real-world evidence supporting the safety and efficacy of the respective COVID-19 vaccines.  Both Moderna and Pfizer/BioNTech announced that their respective vaccines would be available in the coming days.

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