SPIKEVAX
STN: 125752
Proper Name: COVID-19 Vaccine, mRNA
Tradename: SPIKEVAX
Manufacturer: Moderna Tx Inc.
Indication:
- For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older
Product Information
- Package Insert - SPIKEVAX
- Patient Package Insert - SPIKEVAX
- Demographic Subgroup Information – COVID-19 Vaccine, mRNA (SPIKEVAX).
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.