In a significant step toward bolstering public health preparedness, Moderna Inc. has received commercial authorization from the European Commission (EC) for its updated COVID-19 vaccine, Spikevax, targeting the SARS-CoV-2 variant LP.8.1. The vaccine is approved for active immunization in individuals aged six months and older.
This authorization follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The vaccine update aims to provide enhanced protection against evolving strains of the virus and is expected to be available across all 27 EU member states, including Norway, Iceland, and Liechtenstein, during the 2025–2026 vaccination cycle.
Moderna, a leader in mRNA technology, continues to innovate in the fight against infectious diseases. With this latest approval, the company strengthens its global strategy to address current and future public health threats.
A Step Toward Future Readiness
The updated Spikevax vaccine underwent rigorous clinical evaluations before approval. Moderna aims to improve upon previous formulations that had mixed public reception due to concerns over side effects. The new version is designed to boost immunity more effectively, preparing populations for potential future outbreaks and offering stronger, more targeted protection.
Ongoing Global Review and Rollout Plans
Moderna’s updated vaccine formulation is also under regulatory review in other countries. The company is aligning with global health authority guidelines as it continues to expand access to mRNA-based vaccines. Common side effects such as fatigue, chills, headache, and muscle pain remain expected post-injection, as with previous COVID-19 vaccine versions.
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Leadership Comments
Stéphane Bancel, Chief Executive Officer of Moderna, expressed appreciation for the European Commission’s swift action:
“We are grateful for the EC’s timely review and are proud to offer our updated COVID-19 vaccine to help protect people across Europe. COVID-19 continues to challenge global health systems, and this approval reinforces our commitment to public health. We encourage individuals to speak with their healthcare providers about receiving the updated vaccine.”
With this approval, Moderna reinforces its position as a global pioneer in vaccine development, committed to protecting communities through science-driven, next-generation medical solutions.
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