European Commission Grants Marketing Authorization for Moderna's Updated Spikevax Vaccine

Moderna has received marketing authorization from the European Commission for its updated Spikevax vaccine, targeting the LP.8.1 variant of SARS-CoV-2. The vaccine is approved for individuals six months and older and will be available for eligible populations ahead of the 2025-2026 vaccination season.

Moderna, Inc. (NASDAQ: MRNA) has received marketing authorization from the European Commission for its updated COVID-19 vaccine, Spikevax, targeting the LP.8.1 variant of SARS-CoV-2. The vaccine is now approved for individuals aged six months and older, aligning with recommendations from global health organizations to update COVID-19 vaccines for the 2025-2026 vaccination season [1].

The approval covers all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The vaccine is expected to be available for eligible populations before the 2025-2026 vaccination season begins. This authorization follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) [2].

Moderna's updated Spikevax vaccine has been generally well-tolerated, with common adverse events including injection site pain, headache, fatigue, myalgia, and chills. The company has also submitted additional regulatory applications for its updated COVID-19 vaccines targeting LP.8.1 in various regions around the world.

Moderna remains a leader in the field of mRNA medicine, having developed one of the earliest and most effective COVID-19 vaccines. The company continues to advance mRNA technology to transform how medicines are made and to treat and prevent diseases.

References:
[1] https://seekingalpha.com/news/4475592-moderna-gets-eu-nod-for-updated-covid-19-vaccine
[2] https://finance.yahoo.com/news/moderna-receives-european-commission-approval-200500937.html