Moderna COVID-19 Vaccine
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 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).
- Mandatory requirements for the administration of mRNA-1273 under the EUA are as follows:
- 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.
- 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.
- 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.
- 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.
- The following are eligible for a booster:
- 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.
-- To view the remaining sections of this topic, please log in or purchase a subscription --
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).
- Mandatory requirements for the administration of mRNA-1273 under the EUA are as follows:
- 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.
- 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.
- 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.
- 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.
- The following are eligible for a booster:
- 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: December 22, 2022
Citation
Dzintars, Kathryn. "Moderna COVID-19 Vaccine." Johns Hopkins HIV Guide, 2022. Johns Hopkins Guide, www.hopkinsguides.com/hopkins/view/Johns_Hopkins_HIV_Guide/545306/all/Moderna_COVID_19_Vaccine.
Dzintars K. Moderna COVID-19 Vaccine. Johns Hopkins HIV Guide. 2022. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_HIV_Guide/545306/all/Moderna_COVID_19_Vaccine. Accessed January 28, 2023.
Dzintars, K. (2022). Moderna COVID-19 Vaccine. In Johns Hopkins HIV Guide https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_HIV_Guide/545306/all/Moderna_COVID_19_Vaccine
Dzintars K. Moderna COVID-19 Vaccine [Internet]. In: Johns Hopkins HIV Guide. ; 2022. [cited 2023 January 28]. Available from: https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_HIV_Guide/545306/all/Moderna_COVID_19_Vaccine.
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