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A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283.222 Administered as a Booster Dose Compared With mRNA-1273.222 in Participants Aged 12 Years and Older for the Prevention of COVID-19

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Trial Profile

A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283.222 Administered as a Booster Dose Compared With mRNA-1273.222 in Participants Aged 12 Years and Older for the Prevention of COVID-19

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Mar 2026

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At a glance

  • Drugs MRNA 1283 (Primary) ; Elasomeran
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms NextCOVE
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 17 Feb 2026 According to a Moderna Therapeutics media release, 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.
  • 15 Dec 2025 According to a Moderna Therapeutics media release, Moderna has filed mRNA-1283 for approval with regulators in multiple markets around the world, and has received approval from the U.S. Food and Drug Administration (FDA) and Health Canada.
  • 15 Dec 2025 According to a Moderna Therapeutics media release, company announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization of 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. Following the CHMP opinion, the European Commission will make a marketing authorization decision.

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