Moderna Receives FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant

CAMBRIDGE, MA / ACCESSWIRE / August 22, 2024 - Moderna, Inc. (NASDAQ:MRNA) has announced that the U.S. FDA approved the supplemental Biologics License Application for Spikevax® (2024-2025 formula) for individuals aged 12 and above. Emergency Use Authorization has been granted for those aged 6 months through 11 years.

The vaccine targets the KP.2 variant of SARS-CoV-2 and will be available in pharmacies and healthcare settings across the U.S. in the coming days. Moderna CEO Stéphane Bancel emphasized the importance of staying current with COVID-19 vaccinations to prevent severe illness.

The FDA's decision is based on preclinical data and previous evidence supporting the vaccine's efficacy and safety. Moderna's updated vaccine contains a monovalent KP.2 composition as recommended by the FDA.

In addition to the KP.2 variant, Moderna is also developing a vaccine targeting the JN.1 variant, with regulatory decisions anticipated soon.

Moderna's vaccines have been well-tolerated, with common adverse reactions being injection site pain, headache, fatigue, myalgia, and chills.