SARS-CoV-2 virus (COVID-19) Vaccine

General Dosing Information

• There is no data available on the interchangeability of the Pfizer-BioNTech COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. Patients who receive the first dose of Pfizer-BioNTech COVID-19 vaccine should receive a second dose of Pfizer-BioNTech COVID-19 vaccine to complete the vaccination series.

• There is no available information on coadministration of the Pfizer-BioNTech COVID-19 vaccine with other vaccines. During clinical trials, the Pfizer-BioNTech COVID-19 vaccine protocol allowed influenza vaccines to be administered at least 14 days before or after the COVID-19 vaccine doses.[66160]

Advisory Committee on Immunization Practices (ACIP) Interim Recommendations for Vaccine Allocation (Phase 1a)

• In the initial phase of the vaccination program, it is recommended that both health care personnel and residents of long-term care facilities (LTCFs) are the first to be offered the COVID-19 vaccine.

• Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.

• Residents of LTCFs are defined as adults who reside in facilities providing services, including medical and personal care, to those who are not able to live independently.

• Priority may be given to health care personnel who work in close proximity (within 6 feet) to other people.

• Priority may also be given to residents and health care personnel in skilled nursing facilities due to high medical acuity and COVID-19-associated mortality among residents in these settings.[66165]

INVESTIGATIONAL USE: For the prevention of coronavirus disease 2019 (COVID-19): Intramuscular dosage (Pfizer-BioNTech COVID-19 vaccine): Adults: 0.3 mL (30 mcg) IM for 2 doses administered 21 days apart.[66080] Adolescents 16 years and older: 0.3 mL (30 mcg) IM for 2 doses administered 21 days apart. Of note, Emergency Use Authorization is based on extrapolation of adult safety and efficacy data.[66080]

Maximum Dosage Limits

• Adults 0.3 mL/dose IM.

• Geriatric 0.3 mL/dose IM.

• Adolescents 16 years and older: 0.3 mL/dose IM. 15 years and younger: safety and efficacy have not been established.

• Children Safety and efficacy have not been established.

• Infants Safety and efficacy have not been established.

• Neonates Safety and efficacy have not been established.

Patients with Hepatic Impairment Dosing Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Patients with Renal Impairment Dosing Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

†Off-label indication