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

  • The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside-modified RNA (mRNA) vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 spike protein.
    • Two-dose series, given 21 days apart
  • The US FDA issued an Emergency for Use Authorization (EUA) to permit the emergency use of the Pfizer-BioNTech COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 16 years of age and older.
    • Mandatory requirements for the administration of BNT162b2 under the EUA are as follows:
      • The vaccine is authorized in patients ≥ 16 years of age.
      • The vaccination provider must give the individual receiving the Pfizer-BioNTech COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” prior to 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 including death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, 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 Pfizer-BioNTech COVID-19 Vaccine to recipients.
  • There are no data on the interchangeability of COVID-19 vaccines. If the series is initiated with the Pfizer-BioNTech product, it should be completed with the Pfizer-BioNTech product.

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

VACCINE TYPE

  • The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside-modified RNA (mRNA) vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 spike protein.
    • Two-dose series, given 21 days apart
  • The US FDA issued an Emergency for Use Authorization (EUA) to permit the emergency use of the Pfizer-BioNTech COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 16 years of age and older.
    • Mandatory requirements for the administration of BNT162b2 under the EUA are as follows:
      • The vaccine is authorized in patients ≥ 16 years of age.
      • The vaccination provider must give the individual receiving the Pfizer-BioNTech COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” prior to 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 including death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, 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 Pfizer-BioNTech COVID-19 Vaccine to recipients.
  • There are no data on the interchangeability of COVID-19 vaccines. If the series is initiated with the Pfizer-BioNTech product, it should be completed with the Pfizer-BioNTech product.

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Last updated: December 17, 2020