Serious vaccine risks accepted by FDA

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: