Moderna Gains EU Approval for COVID-19 Vaccine mNEXSPIKE; FDA to Review Flu Vaccine
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
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 on February 17, 2026. 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.
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 has already received regulatory approval for mNEXSPIKE in the United States, Canada and Australia and is pursuing approvals in additional markets worldwide.
In a separate regulatory development, the U.S. Food and Drug Administration reversed an earlier decision and agreed to review the company's application for its new seasonal flu vaccine. The move came about a week after the agency had issued a "refusal to file" letter, initially declining to consider the vaccine candidate, mRNA-1010. Following a meeting with regulators, Moderna revised its application with a new approach based on age. The company sought full approval for adults aged 50 to 64 and accelerated approval for those 65 and older.
The FDA accepted the amended application and set a target decision date of August 5, 2026. If approved, Moderna aimed to make the vaccine available for the 2026-2027 flu season, removing a significant regulatory hurdle.
Price targets for Moderna shares increased following the regulatory news. One firm increased its price target from $25.00 to $30.00, while another raised its target to $41.00 from $36.00. A third firm maintained an In-Line rating and raised the price target from $28 to $35.
Moderna shares showed double digit returns over the past week, month, and past 3 months. The stock has a 1-day return of 6.08% and a 90-day share price return of 108.41%. However, the 3-year total shareholder return of a 70.54% decline highlights how recent momentum contrasts with weaker longer term outcomes at a latest share price of $46.60. Moderna is up 51.1% since the beginning of the year, but at $46.62 per share, it is still trading 10.1% below its 52-week high of $51.87 from January 2026.