BNT162b2 COVID-19 Vaccine (BioNTech/Pfizer)

Kathryn Dzintars, Pharm.D., BCPS
BNT162b2 COVID-19 Vaccine (BioNTech/Pfizer) is a topic covered in the Johns Hopkins HIV Guide.

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VACCINE TYPE

  • On August 23, 2021, the FDA approved the Pfizer-BioNTech COVID-19 vaccine for individuals ≥ 16 years of age. It remains under the EUA for individuals aged 12 - 15 years and was expanded to include children aged 5 - 11 years at a reduced dose. On June 17th, 2022, the FDA recommended lowering the age eligibility to any child 6 months of age and older.
  • The Pfizer-BioNTech COVID-19 vaccine (BNT162b2; Comirnaty) is a lipid nanoparticle-formulated, nucleoside-modified RNA (mRNA) vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 spike protein.
    • Primary series: two-dose series, given 21 days apart
      • 21 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 out 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.
        • 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 (based on expert opinion only).
    • Booster dose:
      • Should be given to anyone aged 5 years and older.
      • Booster doses should be administered 5 months after completing the primary vaccination series. Booster doses can be administered at 3 months in the immunocompromised patient.
      • A second booster dose is recommended at least 4 months after the initial booster dose for individuals over the age of 50, and those aged 12 and over with certain types of immune compromise.
      • On August 31, 2022, the FDA approved the Emergency Use Authorization for Pfizer-BioNTech COVID-19 BIVALENT (Original + Omicron BA.4/BA.5).
        • The bivalent vaccine can be given to individuals ≥ 12 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.
  • The Emergency Use Authorization (EUA) remains in effect for the Pfizer-BioNTech COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 5 - 15 years of age.
    • Mandatory requirements for the administration of BNT162b2 under the EUA are as follows:
      • The vaccination provider must give the individual receiving the Pfizer-BioNTech COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” before the individual receiving the Pfizer-BioNTech COVID-19 vaccine.
      • Vaccine providers must include vaccine information to 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 adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, 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 Pfizer-BioNTech COVID-19 Vaccine to recipients.
  • There are limited data on the interchangeability of COVID-19 vaccines. If the primary series is initiated with the Pfizer-BioNTech product, the primary series should be completed with the Pfizer-BioNTech product.
    • Booster shots can be administered with any of the COVID-19 vaccines authorized in the U.S. (mRNA vaccines preferred; those aged 5 - 17 years can receive only the Pfizer-BioNTech vaccine).

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VACCINE TYPE

  • On August 23, 2021, the FDA approved the Pfizer-BioNTech COVID-19 vaccine for individuals ≥ 16 years of age. It remains under the EUA for individuals aged 12 - 15 years and was expanded to include children aged 5 - 11 years at a reduced dose. On June 17th, 2022, the FDA recommended lowering the age eligibility to any child 6 months of age and older.
  • The Pfizer-BioNTech COVID-19 vaccine (BNT162b2; Comirnaty) is a lipid nanoparticle-formulated, nucleoside-modified RNA (mRNA) vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 spike protein.
    • Primary series: two-dose series, given 21 days apart
      • 21 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 out 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.
        • 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 (based on expert opinion only).
    • Booster dose:
      • Should be given to anyone aged 5 years and older.
      • Booster doses should be administered 5 months after completing the primary vaccination series. Booster doses can be administered at 3 months in the immunocompromised patient.
      • A second booster dose is recommended at least 4 months after the initial booster dose for individuals over the age of 50, and those aged 12 and over with certain types of immune compromise.
      • On August 31, 2022, the FDA approved the Emergency Use Authorization for Pfizer-BioNTech COVID-19 BIVALENT (Original + Omicron BA.4/BA.5).
        • The bivalent vaccine can be given to individuals ≥ 12 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.
  • The Emergency Use Authorization (EUA) remains in effect for the Pfizer-BioNTech COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 5 - 15 years of age.
    • Mandatory requirements for the administration of BNT162b2 under the EUA are as follows:
      • The vaccination provider must give the individual receiving the Pfizer-BioNTech COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” before the individual receiving the Pfizer-BioNTech COVID-19 vaccine.
      • Vaccine providers must include vaccine information to 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 adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, 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 Pfizer-BioNTech COVID-19 Vaccine to recipients.
  • There are limited data on the interchangeability of COVID-19 vaccines. If the primary series is initiated with the Pfizer-BioNTech product, the primary series should be completed with the Pfizer-BioNTech product.
    • Booster shots can be administered with any of the COVID-19 vaccines authorized in the U.S. (mRNA vaccines preferred; those aged 5 - 17 years can receive only the Pfizer-BioNTech vaccine).

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Last updated: September 19, 2022