VACCINE TYPE

• Effective April 19, 2023, the Moderna monovalent COVID-19 vaccine is no longer recommended for use; all doses to be given moving forward will be with the bivalent vaccine. The bivalent vaccine is not licensed for any use but remains under Emergency Use Authorization for all individuals 6 months of age and older.
• The Moderna COVID-19 vaccine (mRNA-1273) is a lipid nanoparticle-encapsulated, nucleoside-modified messenger RNA vaccine that encodes the SARS-CoV-2 spike glycoprotein.
  • Primary series: Single dose, 0.5 mL
  • An additional bivalent vaccine dose for patients > 65 years of age or those who are immune compromised can be given at least 4 months after the previous bivalent dose.
• Catch-up vaccination:
  • Individuals 6 months through 5 years previously vaccinated with the Moderna vaccine
    • One previous dose: give a single dose, 0.25 mL, one month after being given the Moderna vaccine
    • Two previous doses: give a single dose, 0.2 mL, at least 2 months after being given the Moderna vaccine
  • Individuals 6 years of age and older previously vaccinated with one or more doses of the Moderna vaccine
    • 6 - 11 years: give a single dose, 0.25 mL, at least 2 months after being given the Moderna vaccine
    • 12 - 64 years: give a single dose, 0.5 mL, at least 2 months after being given the Moderna vaccine
    • ≥ 65 years: give a single dose, 0.5 mL, at least 2 months after being given the Moderna vaccine
      • One additional dose, 0.5 mL, may be administered at least 4 months after the previous bivalent dose
• Mandatory requirements for the administration of mRNA-1273 under the EUA are as follows:
  • The vaccine is authorized in patients ≥ 6 months of age.
  • The vaccination provider must give the individual receiving the Moderna COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” before receiving the Moderna COVID-19 vaccine.
  • Vaccine providers must include vaccine information in the state’s or local jurisdiction’s Immunization Information System or other designated systems.
  • Vaccine providers are responsible for reporting certain events to the Vaccine Adverse Events Reporting System (VAERS):
    • Vaccine administration errors, whether or not associated with an adverse event
    • Serious adverse events include death, life-threatening, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, and congenital anomaly/birth defects.
    • Cases of multisystem inflammatory syndrome (MIS) in children and adults
    • Cases of COVID-19 that result in hospitalization and death
  • Vaccine providers are responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna or Pfizer-BioNTech COVID-19 Vaccine to recipients.
    • This also includes cases of multisystem inflammatory syndrome (see SARS-CoV-2, COVID-19 module for details).