Comirnaty and Spikevax Cleared for Children Six Months and Older

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June 17, 2022 – Comirnaty® (COVID-19 vaccine, mRNA) and Spikevax® (COVID-19 vaccine, mRNA) have been granted emergency use authorization (EAU) to prevent COVID-19 in children who are at least six months of age. This expands the age group for which both vaccines are authorized.

  • Comirnaty, made by Pfizer and BioNTech, previously held an EUA for use in children at least five years of age, and full FDA approval for adults and for adolescents ages 16 and up.
  • Moderna’s Spikevax is FDA approved for adults ages 18 and up.
  • For both vaccines, the recommended dosing for pediatric patients varies based on age and whether the patient has a compromised immune system. Patients may require a two-dose primary vaccination series, a three-dose primary vaccination series, or a two-dose primary vaccination series plus a booster shot.
  • Comirnaty and Spikevax have been used to prevent COVID-19 in the U.S. since 2020.