Moderna Receives UK and EU Approvals for COVID-19 Vaccines
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Moderna's updated COVID-19 mRNA vaccine, Spikevax, targeting the SARS-CoV-2 LP.8.1 variant, for adults and children aged six months and above. Following the MHRA decision, doses of the updated Spikevax vaccine for the UK public will be supplied from the Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire, for the 2026 NHS COVID-19 vaccination campaign this spring.
The LP.8.1 vaccine will be the first commercially available mRNA vaccine manufactured within the UK. The MITC was officially opened in September 2025 as part of a ten-year strategic partnership between Moderna and the UK Government, managed by the UK Health Security Agency (UKHSA). The partnership is designed to strengthen the UK's pandemic preparedness by on-shoring vaccine manufacturing, securing timely access to mRNA vaccines and building long-term national capability across clinical research and advanced manufacturing, supporting the continued growth of the UK's life sciences ecosystem.
The MHRA's approval follows guidance from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), which recommended that COVID-19 vaccines be updated with the monovalent LP.8.1 antigen for 2026 vaccination campaigns. Moderna's updated COVID-19 vaccine targeting LP.8.1 has already been granted approval by several key regulators including the FDA (United States) and EMA (European Union).
Separately, the European Commission (EC) has granted marketing authorization for mNEXSPIKE (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. This marketing authorization follows the positive opinion adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and marks Moderna's third product authorized in the European Union, alongside Spikevax and mRESVIA, further strengthening the company's respiratory vaccine portfolio in Europe.
The marketing authorization is valid in all 27 European Union Member States, as well as Iceland, Liechtenstein and Norway. Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local market access pathways.
The EC decision is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial, which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective of the study was to demonstrate non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. In the trial, participants received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax.
mNEXSPIKE showed a 9.3% higher relative vaccine efficacy compared to Spikevax in individuals aged 12 years and older, and in a descriptive subgroup analysis, a 13.5% higher relative vaccine efficacy in adults aged 65 years and older. In the Phase 3 trial, mNEXSPIKE was found to have a similar safety profile to Spikevax, with fewer local reactions and comparable systemic reactions. The most commonly solicited adverse reactions were injection pain, fatigue, headache and myalgia.
Moderna has already received regulatory approval for mNEXSPIKE in the U.S., Canada and Australia, and continues to pursue approvals in additional markets worldwide. Moderna reported total revenue for the full year 2025 of $1.9 billion, a 40% decrease compared to 2024, with the majority generated from COVID vaccine sales.