MNEXSPIKE

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

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.

Product Information

• Package Insert - MNEXSPIKE
• Patient 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.

Supporting Documents

• September 26, 2025 Chair Review Memorandum - MNEXSPIKE
• August 27, 2025 Approval Letter - MNEXSPIKE
• August 26, 2025 Center Director Decisional Memo - MNEXSPIKE
• July 3, 2025 Approval Letter - MNEXSPIKE
• May 30, 2025 Center Director Override Memo - MNEXSPIKE
• May 30, 2025 Approval Letter - MNEXSPIKE
• May 30, 2025 Summary Basis for Regulatory Action - MNEXSPIKE
• Letters, Reviews, Related Documents – MNEXSPIKE