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.

To view the entire topic, please or .

Official website of the Johns Hopkins Antibiotic (ABX), HIV, Diabetes, and Psychiatry Guides, powered by Unbound Medicine. Johns Hopkins Guide App for iOS, iPhone, iPad, and Android included. Explore these free sample topics:

-- The first section of this topic is shown below --

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.
  • 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
      • 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 the completion of the initial two-dose series (this is based on expert opinion only).
    • Booster dose:
      • Should be given to anyone aged 18 years and older.
      • Booster doses should be administered 6 months after completing the primary vaccination series.
  • The Emergency for 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 Pfizer-BioNTech 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 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 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 (6 months after the primary series) can be administered with any of the COVID-19 vaccines authorized in the U.S.

-- To view the remaining sections of this topic, please or --

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.
  • 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
      • 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 the completion of the initial two-dose series (this is based on expert opinion only).
    • Booster dose:
      • Should be given to anyone aged 18 years and older.
      • Booster doses should be administered 6 months after completing the primary vaccination series.
  • The Emergency for 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 Pfizer-BioNTech 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 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 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 (6 months after the primary series) can be administered with any of the COVID-19 vaccines authorized in the U.S.

There's more to see -- the rest of this entry is available only to subscribers.

Last updated: December 2, 2021