Moderna’s mNEXSPIKE mRNA COVID-19 Shot Approved by European Commission

The European Commission (EC) has granted marketing authorization for Moderna’s mNEXSPIKE mRNA COVID-19 shot, allowing it to be marketed across the European Union (U.N.). The authorization follows a regulatory review and permits all 27 E.U. Member States, as well as Iceland, Liechtenstein and Norway, to consider the shot for use within their vaccination programs. It allows the vaccine to be used in individuals aged 12 years of age and older.¹

The EC based its decision on results from a Phase 3 clinical trial that researchers designed as a randomized, observer-blind, active-controlled study. The trial enrolled about 11,400 participants aged 12 and older. Researchers aimed to determine whether mNEXSPIKE using mRNA technology could provide protection against the SARS-CoV-2 virus that was at least comparable to Moderna’s earlier mRNA COVID shot, Spikevax (mRNA-1273), beginning 14 days after vaccination.²

During the study, researchers gave participants either a 10-microgram dose of mNEXSPIKE or a 50-microgram dose of Spikevax. The results showed that mNEXSPIKE provided 9.3 percent higher relative vaccine efficacy against COVID compared with Spikevax in people aged 12 and older. In a subgroup analysis focusing on older adults, the vaccine showed 13.5 percent higher relative efficacy in participants aged 65 and older.³

Researchers evaluated the safety of the shot during the trial. They found that mNEXSPIKE had a safety profile similar to Spikevax. Participants who received mNEXSPIKE reported fewer reactions at the injection site, while overall body-wide reactions were comparable between the two vaccines. The most commonly reported side effects included pain at the injection site, fatigue, headache and muscle pain.⁴

According to the U.S. Food and Drug Administration’s (FDA) approved manufacturer’s vaccine insert for mNEXSPIKE, post-marketing data from authorized or approved mRNA COVID shots show an increased risk of myocarditis and pericarditis. These conditions most often occur within the first week after vaccination, and the highest risk has been observed in males between the ages of 12 and 24 years.⁵

Analyses of commercial health insurance claims from both inpatient and outpatient settings provide estimates of how often these cases occur. During the period from one to seven days after people received the 2023–2024 formula of mRNA COVID shot, researchers estimated about eight cases of myocarditis or pericarditis per one million doses among individuals aged six months through 64 years. Among males aged 12 to 24, the estimated rate was higher, at about 27 cases per one million doses.⁶

mNEXSPIKE Approval in U.S. Limited to Specific Groups

In the United States, the FDA approved mNEXSPIKE for use on Aug. 27, 2025. The authorization allows adults aged 65 years of age and older to receive mNEXSPIKE. It also allows use in individuals aged 12 through 64 who have at least one underlying health condition that increases their risk of severe COVID illness from a SARS-CoV-2 infection. This means the shot is not approved for widespread use among the entire population. Instead, the FDA restricted eligibility to groups considered to be at higher risk of severe COVID disease.⁷

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