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Subsections
COVID-19 Vaccine (mRNA - Pfizer-BioNTech)

{Vaccines}

COVID-19 VACCINE (mRNA - Pfizer-BioNTech)

NOTE: FDA has authorized (6 mo-11 yo) and approved (≥12 yo) the 2024-2025 formulation (Omicron variant lineage KP.2) to be used for all doses administered, including additional dose(s) for certain populations

Adult Dosing

  • Regardless of vaccination status
    • 0.3 mL IM x1; if previously vaccinated, admin ≥2 mth after last dose
  • Immunocompromised
    • Not previously vaccinated:
      • 0.3 mL IM x3; given at 3 wk interval between dose 1 and 2, THEN
      • Dose 3 given ≥4 wks later
    • Single previous Pfizer-BioNTech dose (any formulation):
      • 0.3 mL IM x2; dose 1 given 3 wks after last dose, THEN
      • Dose 2 given ≥4 wks later
    • 2 previous Pfizer-BioNTech doses (any formulation):
      • 0.3 mL IM x1; given ≥4 wks after last dose
    • ≥3 previous doses (not including 2024-2025 formulation):
      • 0.3 mL IM x1; given ≥8 wks after last dose
    • ≥1 dose Novavax (not including 2024-2025 formulation):
      • 0.3 mL IM x1; given ≥8 wks after last dose
    • Additional 0.3 mL dose may be admin ≥2 mth after completion of series
      • Subsequent doses may be admin at provider discretion
    • May consider pemivibart if unlikely to mount adequate vaccine response
  • See CDC guidelines for information on receiving a booster dose if vaccinated outside US
  • Administration:
    • Give IM only in deltoid
    • Recommend 15 min observation post-admin, OR
      • 30 min Hx of hypersensitivity
    • May be given concomitantly with other vaccines without regards to time
      • Admin multiple vaccines in different injection site
    • Also see injection information

Pediatric Dosing

  • Not previously vaccinated
    • 6 mo-4 yo: 0.3 mL IM x3
      • Given on wk 0, 3, and ≥8 wks after Dose 2
      • If turning 4 to 5 yo during series, pt should receive all doses
    • 5-11 yo: 0.3 mL IM x1
    • ≥12 yo: as adult
  • Previously vaccinated
    • 6 mo-4 yo:
      • 1 previous dose: 0.3 mL IM x2
        • Dose 1 given 3-8 wks after last dose
        • Dose 2 given ≥8 wks after Dose 1
        • If turning 4 to 5 yo during series, pt should receive all doses
      • 2 previous doses (any formulation): 0.3 mL IM x1
        • Given ≥8 wks after last dose
      • ≥3 previous doses (not including 2024-2025 formulation): 0.3 mL IM x1
        • Given ≥8 wks after last dose
      • ≥3 previous doses (including 2024-2025 formulation): no further doses indicated
    • 5-11 yo:
      • ≥1 previous doses (not including 2024-2025 formulation): 0.3 mL IM x1
        • Given ≥2 mths after last dose
      • ≥1 previous doses (including 2024-2025 formulation): no further doses indicated
    • ≥12 yo: as adult
  • Immunocompromised
    • ≥12 yo:
    • 6 mo-11 yo:
      • 0.3 mL IM; admin ≥3-dose series
        • 6 mo-4 yo: given on wk 0, 3, and ≥8 wks after Dose 2
        • 5-11 yo: given on wk 0, 3, and ≥4 wks after Dose 2
      • Not previously vaccinated:
        • Complete full 3-dose series
      • Previously vaccinated with 1-2 dose(s) (any formulation):
        • Complete remaining dose(s) in 3-dose series
      • Previously vaccinated with ≥3 doses (not including 2024-2025 formulation):
        • Admin single dose, given ≥2 mth after last dose
      • Additional 0.3 mL dose may be admin ≥2 mth after completion of series
        • Subsequent doses may be admin at provider discretion
  • Administration
    • Give IM only in deltoid
    • Recommend 15 min observation post-admin, OR
      • 30 min Hx of hypersensitivity
    • May be given concomitantly with other vaccines without regards to time
      • Administer multiple vaccines in different injection site
    • Different vials designated for use
      • 5-11 yo (10 ug): blue cap (no dilution required)
      • 6 mo-4 yo (3 ug): yellow cap (dilution required)

Renal and Hepatic Dosing

  • Renal
    • No specific recommendations per mfr labeling
  • Hepatic
    • No specific recommendations per mfr labeling

Contraindications & Cautions

  • Contraindications
    • Hypersensitivity
  • Cautions
    • Acute allergic reactions; ensure appropriate anaphylaxis Tx available on site
      • Use caution with Hx of severe allergic reactions
    • Immunocompromised/suppressed pts may have diminished immune response
    • Potential limited effectiveness; may not protect all recipients
      • Optimal protection observed at ≥7 days after second dose in clinical trials
    • Do not admin different products in pts primary vaccine series
      • If different products mistakenly given, no additional doses recommended
      • Boosters may be given interchangeably
    • Recommend vaccination postponement with acute severe febrile illness or known current SARS-CoV-2 infection
    • Anticoagulant Tx; increased risk of bleeding with IM injections
    • Limited reports of facial swelling with dermal filler use
    • Contains polyethylene glycol (PEG); use caution with Hx of polysorbate hypersensitivity
    • Rare cases of myocarditis & pericarditis reported with mRNA vaccination
      • Highest risk following 2nd dose in males 12-39 yo
        • May consider 8 wks between 1st and 2nd dose
      • S/S onset usually within 7 days of admin
      • Generally should not receive an additional dose of any COVID-19 vaccine
      • Patients with Hx of myocarditis/pericarditis unrelated to COVID-19 may be given the vaccine once resolved
    • Urticaria with/with angioedema reported; usually presents within 2 wks of vaccination
      • May persist wks-mths; resolution within 6 mths

Indications & Uses

  • Prevention of COVID-19 caused by SARS-CoV-2

Mechanism of Action

  • SARS-CoV-2 S antigen mRNA delivered to host cell; host cell manufacturers and expresses SARS-CoV-2 S antigen, eliciting immune response

Adverse Drug Reactions

  • Dose 1 (any severity)
    • ≤55 yo
      • Inj site pain (83.1%)
      • Fatigue (47.4%)
      • Headache (41.9%)
      • Myalgia (21.3%)
      • Chills (14%)
      • Diarrhea (11.1%)
      • Arthralgia (11%)
      • Swelling (5.8%
      • Erythema (4.5%)
      • Fever (3.7%)
      • Nausea/Vomiting (1.2%)
    • >55 yo
      • Inj site pain (71.1%)
      • Fatigue (34.1%)
      • Headache (25.2%)
      • Myalgia (13.9%)
      • Arthralgia (8.6%)
      • Diarrhea (8.2%)
      • Swelling (6.5%)
      • Chills (6.3%)
      • Erythema (4.7%)
      • Fever (1.4%)
      • Nausea/Vomiting (0.5%)
  • Dose 2 (any severity)
    • ≤55 yo
      • Inj site pain (77.8%)
      • Fatigue (59.4%)
      • Headache (51.7%)
      • Myalgia (37.3%)
      • Chills (35.1%)
      • Arthralgia (21.9%)
      • Fever (15.8%)
      • Diarrhea (10.4%)
      • Swelling (6.3%)
      • Erythema (5.9%)
      • Nausea/Vomiting (1.9%)
    • >55 yo
      • Inj site pain (66.1%)
      • Fatigue (50.5%)
      • Headache (39%)
      • Myalgia (28.7%)
      • Chills (22.7%)
      • Arthralgia (18.9%)
      • Fever (10.9%)
      • Diarrhea (8.3%)
      • Swelling (7.5%)
      • Erythema (7.2%)
      • Nausea/Vomiting (0.7%)
  • General <1%
    • Lymphadenopathy
    • Malaise
  • Unsolicited Adverse Events (causal relationship not established)
    • Appendicitis
    • Bell’s palsy
  • NOTE: must report all admin errors, serious adverse events, cases of Multisystem Inflammatory Syndrome, and hospitalized or fatal cases of COVID-19 following vaccination to VAERS (https://vaers.hhs.gov/reportevent.html)

Pregnancy and Lactation

  • Pregnancy
    • Risk Summary: data insufficient to establish potential fetal risk
      • ACOG recommends vaccine should not be withheld from pregnant individuals
      • Clinical consideration: pregnant women at increased risk of severe illness from COVID-19
      • Maternal vaccination appears to protect infants in 1st 6 mths of life
    • Registry: https://c-viper.pregistry.com
    • Human Data: limited data available
    • Animal Data: no adverse effects on fetal development observed at RHD (30 mcg) admin x4
  • Lactation
    • Risk Summary: data insufficient to establish risk to breastfed infant
      • mRNA vaccines not thought to present risk to exposed infant
      • ACOG recommends vaccine should be offered to lactating women similar to non-lactating women
    • Effect on production: no data available
    • Minimizing exposure: data lacking; unable to provide specific recommendations
  • Reproductive Risk
    • Contraception: no specific recommendations
    • Fertility: no observed adverse effects on female fertility or IVF cycles

Kinetics/Dynamics

  • Initial Efficacy (mean)
    • 5-11 yo: 90.7%
    • 12-15 yo: 100%
    • 16-64 yo: 90.5%
    • ≥65 yo: 94.5%

Overdose Management

  • Symptomatic/supportive Tx

Interactions

Trade Names

* = Discontinued

  • Dosing Strengths: (suspension for inj) 3 mcg/0.3 mL, 10 mcg/0.3 mL, 30 mcg/0.3 mL
  • United States: Comirnaty; Pfizer-BioNTech COVID-19 Vaccine

Injection Information

  • Injection Preparation:
    • Vial
      • Verify that vial states 2024-2025 Formula
      • Thaw in refrigerator [2º-8ºC (35º-46ºF)] up to 2 hrs OR
        • At room temp [up to 25ºC (77ºF)] up to 30 min
      • Prior to use, mix by inverting vial gently 10x; Do not shake
      • Withdraw single 0.3 mL dose using a sterile needle and syringe
      • Discard vial and any excess volume
      • Admin immediately
    • PFS
      • Verify syringe states 2024-2025 Formula
      • If glass prefilled syringe has been frozen, discard
      • Do not shake
      • Admin with 4 hrs
  • Injection Administration:
    • Verify final dose volume of 0.3 mL
    • Admin IM in deltoid
    • Do not give SC or IV
  • Storage:
    • Avoid exposure to direct sunlight and UV light
    • Store diluted vaccine at 2°-25°C (35°-77°F)

Other Information

References

  1. ASHP Drug Compendium (Pfizer-BioNTech COVID-19 Vaccine (Systemic); Vaccines)
  2. FDA Monograph Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) https://www.fda.gov/media/151707/download (Accessed August 2024)
  3. FDA Emergency Use Authorization Pfizer-BioNTech COVID-19 Vaccine (Omicron variant lineage KP.2) https://www.fda.gov/media/167211/download (Accessed August 2024)
  4. Health Canada Pfizer-BioNTech COVID-19 Vaccine https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf
  5. CDC. Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html
  6. American College of Obstetricians and Gynecologists. Vaccinating Pregnant and Lactating Patients Against COVID-19. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19
  7. Aharon D, Lederman M, Ghofranian A, et al. In Vitro Fertilization and Early Pregnancy Outcomes After Coronavirus Disease 2019 (COVID-19) Vaccination. Obstet Gynecol. 2022 Apr 1;139(4):490-497.

Contributor(s)

  1. Reiner, Stefan, PharmD

Updated/Reviewed: August, 2024