Pfizer-BioNTech COVID-19 Vaccine

Adult Dosing .

Dosage forms:  --

Investigational New Drug (IND)

[FDA emergency use authorization (EUA)]

Info: see Comirnaty for FDA-approved use in pts 12 yo and older

Peds Dosing .

Dosage forms:  INJ

Investigational New Drug (IND)

[FDA emergency use authorization (EUA)]

Info: for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus; not FDA approved; see Comirnaty for FDA-approved use in pts 12 yo and older

[formulation clarification]

Info: blue cap vials = 10 mcg/0.3 mL, use in pts 5-11 yo; yellow cap vials = 3 mcg/0.3 mL, use in pts 6 mo-4 yo

[mandatory reporting]

Info: vaccine administration errors, serious adverse events, Multisystem Inflammatory Syndrome (MIS) cases, pericarditis or myocarditis cases, and COVID-19-related hospitalizations or deaths following vaccination must be reported to Vaccine Adverse Event Reporting System (vaers.hhs.gov/reportevent.html or 1-800-822-7967) and Pfizer Inc. (www.pfizersafetyreporting.com or 1-866-635-8337)

COVID-19 prevention

[6 mo-4 yo, immunocompetent or mildly immunocompromised pts, not previously vaccinated]

Dose: 0.3 mL IM x2 doses 3wk apart, then 0.3 mL IM x1 dose at least 8wk later; Info: may consider giving 2nd dose 8wk after 1st dose; complete regimen for 6 mo-4 yo if turning 5 yo during series; use yellow cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[6 mo-4 yo, immunocompetent or mildly immunocompromised pts, previously received 1 Pfizer-BioNTech vaccine dose]

Dose: 0.3 mL IM x2 doses at least 8wk apart; Start: 3-8wk after last dose; Info: complete regimen for 6 mo-4 yo if turning 5 yo during series; use yellow cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[6 mo-4 yo, immunocompetent or mildly immunocompromised pts, previously received 2 or more Pfizer-BioNTech vaccine doses]

Dose: 0.3 mL IM x1 dose; Start: at least 8wk after last dose; Info: use yellow cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[6 mo-4 yo, moderately-severely immunocompromised pts, not previously vaccinated]

Dose: 0.3 mL IM x2 doses 3wk apart, then 0.3 mL IM x1 dose at least 8wk later, then 0.3 mL IM x1 dose at least 6mo later; Info: complete regimen for 6 mo-4 yo if turning 5 yo during series; may give additional dose at least 2mo after last dose and consider further doses on case-by-case basis; use yellow cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[6 mo-4 yo, moderately-severely immunocompromised pts, previously received 1 Pfizer-BioNTech vaccine dose]

Dose: 0.3 mL IM x2 doses at least 8wk apart, then 0.3 mL IM x1 dose at least 6mo later; Start: 3wk after last dose; Info: complete regimen for 6 mo-4 yo if turning 5 yo during series; may give additional dose at least 2mo after last dose and consider further doses on case-by-case basis; use yellow cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[6 mo-4 yo, moderately-severely immunocompromised pts, previously received 2 or more Pfizer-BioNTech vaccine doses]

Dose: 0.3 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses on case-by-case basis; use yellow cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[5-11 yo, immunocompetent or mildly immunocompromised pts]

Dose: 0.3 mL IM x1 dose; Info: give at least 8wk after last COVID-19 vaccine dose if previously vaccinated; use blue cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[5-11 yo, moderately-severely immunocompromised pts, not previously vaccinated]

Dose: 0.3 mL IM x2 doses 3wk apart, then 0.3 mL IM x1 dose at least 4wk later, then 0.3 mL IM x1 dose at least 6mo later; Info: may consider giving regimen for 12 yo and older if turning 12 yo during primary series; may give additional dose at least 2mo after last dose and consider further doses on case-by-case basis; use blue cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[5-11 yo, moderately-severely immunocompromised pts, previously received 1 Pfizer-BioNTech vaccine dose]

Dose: 0.3 mL IM x2 doses at least 4wk apart, then 0.3 mL IM x1 dose at least 6mo later; Start: 3wk after last dose; Info: may consider giving regimen for 12 yo and older if turning 12 yo during primary series; may give additional dose at least 2mo after last dose and consider further doses on case-by-case basis; use blue cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[5-11 yo, moderately-severely immunocompromised pts, previously received 2 Pfizer-BioNTech vaccine doses]

Dose: 0.3 mL IM x2 doses at least 6mo apart; Start: at least 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses on case-by-case basis; use blue cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

[5-11 yo, moderately-severely immunocompromised pts, previously received 3 or more mRNA vaccine doses]

Dose: 0.3 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses on case-by-case basis; use blue cap vials; search 'immunization' for epocrates Child/Adolescent Immunization decision tool incl. links to CDC/ACIP schedules

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[no adjustment]