Episode Details

Serious Adverse Events https://www.fda.gov/media/186738/download?attachment MNEXSPIKE group Serious adverse events were reported by 2.7% of participants (n=156) Comparator vaccine Serious adverse events were reported by and 2.6% of participants (n=151) (median follow-up of 8.8 months). https://cardiovascular-research-and-innovation.reseaprojournals.com/archive_files/Myocarditis%20after%20SARS-CoV-2%20infection%20and%20COVID-19%20vaccination%20Epidemiology,%20outcomes,%20and%20new%20perspectives.pdf https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx https://www.fda.gov/vaccines-blood-biologics/mnexspike Targeted approach against the JN.1 variant Participants received either mRNA-1283 or mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, a 13.5% higher rVE in adults aged 65 and older. https://clinicaltrials.gov/study/NCT05815498 https://ctv.veeva.com/study/a-study-of-mrna-1283222-injection-compared-with-mrna-1273222-injection-in-participants-12-years-o https://ctv.veeva.com CONTRAINDICATIONS Do not administer MNEXSPIKE to individuals with a known history of severe allergic reaction Myocarditis and Pericarditis, increased risks of myocarditis and pericarditis, risk has been highest in males 12 years through 24 years of age. Onset of symptoms typically in the first week following vaccination Although some individuals with myocarditis and/or pericarditis following administration of mRNA COVID-19 vaccines have required intensive care support, available data suggest that individuals typically have resolution of symptoms within a few days with conservative management. In hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis, Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00388-2/fulltext at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known Information is not yet available about potential long-term sequelae of myocarditis or pericarditis following administration of mRNA COVID-19 vaccines. 5.3 Syncope Syncope (fainting) may occur in association with administration of injectable vaccines. 5.4 Altered Immunocompetence Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to MNEXSPIKE 5.5 Limitations of Vaccine Effectiveness MNEXSPIKE may not protect all vaccine recipients. 6 ADVERSE REACTIONS Most commonly (≥10%) reported adverse reactions following administration of MNEXSPIKE:

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