VACCINE TYPE

• 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.
  • Two-dose series, given one month (28 days) apart
  • A third dose can be administered to select immunocompromised patients a minimum of 28 days after the initial 2-dose series (see below)
  • A booster dose is recommended for all other individuals beginning 8 months after completion of the initial 2-dose series
• The US FDA issued an Emergency Use Authorization (EUA) to permit the emergency use of the Moderna COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older.
  • Mandatory requirements for the administration of mRNA-1273 under the EUA are as follows:
    • The vaccine is authorized in patients ≥ 18 years 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” prior to the individual receiving the Moderna COVID-19 vaccine.
    • Vaccine providers must include vaccine information to either 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 including death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, congenital anomaly/birth defects
      • Cases of a 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 the multisystem inflammatory syndrome (see SARS-CoV-2, COVD-19 module for details).
• There are no data on the interchangeability of COVID-19 vaccines. If the series is initiated with the Moderna product, it should be completed with the Moderna product.
• On August 12, 2021, the EUA was modified to include the administration of a third dose after the initial 2-dose primary series to certain immunocompromised patients (solid organ transplant, active treatment of solid or hematologic malignancies, CAR-T or prolonged immunosuppressive therapy, advanced/untreated HIV infection, active treatment with prednisone ≥20 mg/day)
  • The additional dose should be the same vaccine product as the original two-dose series
  • Administer the additional dose at least 28 days after the completion of the initial two-dose series (this is based on expert opinion only)