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:
    • It 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 ≥ 5 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.
        • For ages 5 - 11 years, the bivalent booster comes in a vial with an orange cap.
        • For ages ≥ 12 years, the bivalent booster comes in a vial with a gray cap.
      • Booster doses should not be administered with the standard vaccine; bivalent only.
      • December 2022: bivalent booster given EUA status for those 6 mos of age and older in the pediatric group.
• 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 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).