Moderna COVID-19 Vaccine

Kathryn Dzintars, Pharm.D., BCPS
Moderna COVID-19 Vaccine is a topic covered in the Johns Hopkins HIV Guide.

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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 18 years or older beginning 5 months after the initial 2-dose series is completed. Immunocompromised patients can receive their booster 3 months after their last dose.
  • 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 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” before 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 include death, life-threatening, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, and congenital anomaly/birth defects.
        • Cases of the 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.
  • 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 18 years of age and older
      • Booster doses should be administered 5 months after completing the primary vaccination series.
        • In the immunocompromised, booster doses can be given 3 months after the primary 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 ≥ 18 years 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.

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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 18 years or older beginning 5 months after the initial 2-dose series is completed. Immunocompromised patients can receive their booster 3 months after their last dose.
  • 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 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” before 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 include death, life-threatening, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, and congenital anomaly/birth defects.
        • Cases of the 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.
  • 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 18 years of age and older
      • Booster doses should be administered 5 months after completing the primary vaccination series.
        • In the immunocompromised, booster doses can be given 3 months after the primary 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 ≥ 18 years 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.

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Last updated: September 19, 2022