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
  • 28 days is recommended between the first and second dose for moderate to severely immunocompromised individuals, those > 65 years of age, and anyone who needs rapid protection due to increased concern for high community transmission. This interval can be increased to 8 weeks in those concerned with a small risk of myocarditis (males aged 12 - 39 years).
  • 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 individuals 6 months of age or older at least 2 months after the initial 2-dose series is completed.
• The U.S. 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 6 months of age through 17 years.
  • 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 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 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 the multisystem inflammatory syndrome (see SARS-CoV-2, COVID-19 module for details).
• There are no data on the interchangeability of COVID-19 vaccines. If the primary series is initiated with the Moderna product, the primary should be completed with the Moderna product.
  • Booster doses can be provided with any of the COVID-19 vaccines approved for use in the U.S.; the mRNA vaccines are preferred. (Janssen, Moderna, Pfizer)
• 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 completing the initial two-dose series (this is based on expert opinion only).
• On October 21, 2021, the CDC recommended booster vaccines for most individuals.
  • The following are eligible for a booster:
    • It should be given to anyone 6 months years of age and older
    • Booster doses should be administered at least 2 months after completing the primary vaccination series..
    • A second booster dose should be offered to individuals 4 months after the initial booster who are over the age of 50, or are 18 years or older with an immunocompromising condition.
    • On August 31, 2022, the FDA issued an Emergency Use Authorization for Moderna BIVALENT (Original PLUS Omicron BA.4/BA.5)
      • The bivalent vaccine can be given to individuals ≥ 6 months of age as a single booster after either the completion of primary vaccination with any authorized monovalent COVID vaccine or after receipt of the most recent booster dose with any authorized monovalent COVID vaccine.
        • Monovalent boosters will no longer be available.
  • Booster doses can be provided with any of the COVID-19 vaccines approved for use in the U.S. (Janssen, Moderna, Pfizer); the mRNA vaccines are preferred.
• FDA fully approved vaccine for ages ≥ 18 years, January 31, 2022.
• On June 17th, 2022, the FDA expanded the age limit to include children > 6 months of age to 17 years.