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  1. Vaccines, Blood, & Biologics

SPIKEVAX

STN: 125752
Proper Name: COVID-19 Vaccine, mRNA
Tradename: SPIKEVAX
Manufacturer: Moderna Tx, Inc

For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

SPIKEVAX is approved for use in individuals who are:

  • 65 years of age and older, or
  • 6 months 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 - 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.
  • Some cartons of SPIKEVAX (2026-2027 Formula) do not identify the SARS-CoV-2 JN.1-descendent variant XFG on their labeling.
    • Each 0.5 mL dose of SPIKEVAX (2026-2027 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG.
    • Each 0.25 mL dose of SPIKEVAX (2026-2027 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG.

Spikevax Safety and Effectiveness FAQ

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