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MNEXSPIKE

STN: 125835 
Proper Name: COVID-19 Vaccine, mRNA
Tradename: MNEXSPIKE
Manufacturer: ModernaTX, Inc.

MNEXSPIKE is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 

MNEXSPIKE is approved for use in individuals who are:

  • 65 years of age and older, or
  • 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

  • Package Insert - MNEXSPIKE
  • Recipients and Caregivers Package Insert - MNEXSPIKE
  • Demographic Subgroup Information – COVID-19 Vaccine, mRNA
    Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
  • Some cartons of MNEXSPIKE (2026-2027 Formula) do not identify the SARS-CoV-2 JN.1-descendent variant XFG on their labeling. 
    • Each 0.2 mL dose of MNEXSPIKE (2026-2027 Formula) contains 10 mcg nucleoside-modified messenger RNA (mRNA) encoding the N-terminal domain (NTD) and receptor-binding domain (RBD) of the spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG.

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