BNT162b2 COVID-19 Vaccine (BioNTech/Pfizer)
- Effective April 19, 2023, the original monovalent Pfizer-BioNTech COVID-19 vaccine is no longer recommended; all doses to be given moving forward will be with the bivalent vaccine.
- The bivalent vaccine is not licensed for any use but remains under Emergency Use Authorization for all individuals 6 months and older.
- The Pfizer-BioNTech COVID-19 vaccine is a lipid nanoparticle-formulated, nucleoside-modified RNA (mRNA) vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 spike protein.
- Primary series: Single dose, 0.3 mL
- An additional bivalent vaccine dose for patients > 65 years of age or those who are immune compromised can be given at least 4 months after the previous bivalent dose.
- Catch-up vaccination
- Individuals who have received one dose of the monovalent vaccine: Two doses of the bivalent vaccine should be given 3 weeks after the first monovalent vaccine, with the second 8 weeks later.
- Individuals who have received two doses of the monovalent vaccine: A single dose of the bivalent vaccine should be given at least 8 weeks after the second dose of the monovalent vaccine.
- Individuals who have received three doses of the monovalent vaccine: A single dose of the bivalent vaccine should be given at least 2 months after the last dose of the monovalent vaccine.
- 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, 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 resulting in hospitalization or death following administration 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 6 months - 17 years can receive only the Pfizer-BioNTech vaccine).
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