Moderna, Inc. (NASDAQ:MRNA) shares are trading higher Tuesday after the company announced European Commission marketing authorization for its COVID-19 vaccine, mNEXSPIKE.
European Commission Grants Marketing Authorization
The European Commission granted marketing authorization for mNEXSPIKE (mRNA-1283) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older.
The authorization follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and marks Moderna's third product authorized in the European Union, alongside Spikevax and mRESVIA. The approval is valid across all 27 European Union member states, as well as Iceland, Liechtenstein and Norway.
The decision was supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial enrolling approximately 11,400 participants aged 12 years and older. The study aimed to demonstrate non-inferior vaccine efficacy against COVID-19 beginning 14 days after vaccination with mNEXSPIKE compared to Spikevax.
Participants received either a 10 microgram dose of mNEXSPIKE or a 50 microgram dose of Spikevax. In the trial, mNEXSPIKE showed a 9.3% higher relative vaccine efficacy compared to Spikevax in individuals aged 12 years and older and a 13.5% higher relative vaccine efficacy in adults aged 65 years and older in a descriptive subgroup analysis.
Moderna said mNEXSPIKE had a similar safety profile to Spikevax, with fewer local reactions and comparable systemic reactions. The most commonly reported adverse reactions were injection pain, fatigue, headache and myalgia.
Moderna said it has already received regulatory approval for mNEXSPIKE in the United States, Canada and Australia and is pursuing approvals in additional markets worldwide.
Evercore ISI Group analyst Cory Kasimov maintained Moderna with an In-Line rating on Tuesday and raised the price target from $28 to $35.
Moderna Stocks Rises Tuesday
MRNA Price Action: At the time of writing, Moderna shares are trading 1.73% higher at $42.90, according to data from Benzinga Pro.
Image via Shutterstock
