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New COVID Vaccine Approved for High-Risk Groups

After showing higher efficacy and a comparable safety profile to Spikevax, the FDA has approved Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk patients.

Conexiant

Moderna’s newly approved mNEXSPIKE vaccine demonstrated a 13.5% higher relative efficacy than Spikevax in adults aged 65 years and older, according to phase 3 trial data.

The FDA has approved Moderna’s COVID-19 vaccine mNEXSPIKE (mRNA-1283) for adults aged 65 years and older and patients aged 12 to 64 years with one or more underlying risk factors, as defined by the CDC. This represents Moderna’s third FDA-approved product, following Spikevax (mRNA-1273) and mRESVIA, its respiratory syncytial virus vaccine.

Approval was supported by data from a phase 3 randomized, observer-blind, active-controlled trial (ClinicalTrials.gov Identifier: NCT05815498) that involved approximately 11,400 patients aged 12 years and older. The trial’s primary objective was to demonstrate noninferior efficacy of mRNA-1283 vs mRNA-1273, beginning 14 days postvaccination. Patients received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax. mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy (rVE) in the overall study population and a 13.5% higher rVE in a descriptive subgroup analysis of adults aged 65 years and older.

The safety profile of mNEXSPIKE was similar to that of Spikevax. Local reactions were less frequent, and systemic reactions were comparable. The most reported adverse events included injection site pain, fatigue, headache, and myalgia. Rare risks such as myocarditis and pericarditis, which were primarily observed in males aged 12 to 24 years, remain consistent with other mRNA COVID-19 vaccines. The vaccine is contraindicated in patients with a history of severe allergic reaction to a previous dose of a Moderna COVID-19 vaccine or its components.

Moderna plans to distribute mNEXSPIKE in the U.S. for the 2025 to 2026 respiratory virus season and notes that regulatory review is ongoing in additional markets. mNEXSPIKE is indicated for patients who have previously received a COVID-19 vaccine and meet eligibility criteria. Moderna cautions that vaccination may not confer protection in all recipients.

Source: Moderna, Inc