Officials with the FDA recently approved a next-generation mRNA COVID-19 vaccine (mNexspike; Moderna) for vaccination against severe acute SARS-CoV-2. The approval of the vaccine was supported by data captured in the NextCOVE (NCT05815498) study, an observer-blinded, active-controlled phase 3 trial conducted among 11,454 participants aged ≥12 years who were randomly assigned to receive either mRNA-1283 or mRNA-1273.1
In a phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly cited adverse events reported included injection site pain, fatigue, headache, and myalgia.
Moderna officials noted in a prepared statement after the approval in May that they expect to have mNEXSPIKE available for eligible populations in the United States for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company’s approved respiratory syncytial virus vaccine.2
References
- Moderna. Moderna receives US FDA approval for COVID-19 vaccine mNEXSPIKE [press release]. Moderna. May 31, 2025. Accessed July 8, 2025. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx
- A study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE). ClinicalTrials.gov identification: NCT05815498. Updated May 7, 2025. Accessed July 8, 2025. https://clinicaltrials.gov/study/NCT05815498?term=NCT05815498&rank=1