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EUA FACT SHEETS

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet for Recipients and Caregivers

Dosing and Administration

For individuals 12 years of age and older

Vaccine is administered as
a series of 2 doses three weeks apart

Day 0

30 mcg (0.3 mL)

Intramuscular Injection
Day 21

30 mcg (0.3 mL)

Intramuscular Injection

Multiple Dose Vial – Six Doses

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:

  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Do not pool excess vaccine from multiple vials

Description

Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.

It also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

Dosing and Schedule

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart.

There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.

Dose Preparation

Thawing Prior to Dilution

Thaw
  • Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by:
    • Allowing vial(s) to thaw in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month
    • Allowing vial(s) to sit at room temperature [up to 25°C (77°F)] for 30 minutes
  • Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours
First Mix

Invert

  • Before dilution invert vaccine vial gently 10 times
  • Do not shake
  • Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles
  • Do not use if liquid is discolored or if other particles are observed
Inject Saline

Dilute

  • Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent
  • Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle)
  • Cleanse the vaccine vial stopper with a single-use antiseptic swab
  • Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial
Remove Air

Equalize

  • Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL of air into the empty diluent syringe
Second Mix

Invert

  • Gently invert the vial containing the Pfizer-BioNTech COVID-19 Vaccine 10 times to mix
  • Do not shake
  • Inspect the vaccine in the vial
  • The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter
text B&W

Record and Store

  • Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label
  • Store between 2°C to 25°C (35°F to 77°F)
  • Discard any unused vaccine 6 hours after dilution

Preparation of Individual 0.3 mL Doses of Pfizer-BioNTech COVID-19 Vaccine

Draw Dose

Cleanse

  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using low dead-volume syringes and/or needles
  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Administer immediately

Administration

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-white suspension. During the visual inspection,

  • verify the final dosing volume of 0.3 mL
  • confirm there are no particulates and that no discoloration is observed
  • do not administer if vaccine is discolored or contains particulate matter

Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:

  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Do not pool excess vaccine from multiple vials

Review the Product Safety Data Sheet for the vaccine. In the event of vial breakage, damage, or leakage, to prevent cuts and exposure to the vaccine, do not handle the vial with bare hands; wear protective gloves. Remove broken glass with forceps, tongs, or other appropriate tools. Dispose of the vial and vial pieces in a medical sharps container.


  • Important Safety Information

    • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine

      Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html)

    • Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances
    • Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
    • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
    • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
    • In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
    • Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials:
      • severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm)
      • myocarditis and pericarditis

      Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine

    • Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
    • Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
    • There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
    • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
    • Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
    • Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com


For more information

Medical Information
Visit PfizerMedicalInformation.com or call 1-800-438-1985.

General Product Inquiries
Call 1-877-829-2619.

Shipment Support
US Trade Customer Service
Call 1-800-666-7248.