Full Prescribing Information & EUA Fact Sheets

FDA EUA Letter (12 Years & Up) Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers - 12 Years & Up EUA Fact Sheet for Recipients and Caregivers - 12 Years & Up

Dosing and Administration1

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

*According to the Emergency Use Authorization Fact Sheet for Vaccination Providers, a third dose of the vaccine (0.3 mL) administered at least 28 days following the second dose of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.2

Multiple Dose Vial – Six Doses

After dilution, vials of the 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

The vaccine is a sterile suspension for injection for intramuscular use. It is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose of the vaccine contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.


Each 0.3 mL dose of the vaccine 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.

The vaccine does not contain preservative.

The vial stoppers are not made with natural rubber latex.

Dosing and Schedule

The vaccine is administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart.

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA‑authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.2

There are no data available on the interchangeability of the vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received 1 dose of the vaccine should receive a second dose of the vaccine to complete the vaccination series.

According to the Emergency Use Authorization Fact Sheet for Vaccination Providers, a third dose of the vaccine (0.3 mL) administered at least 28 days following the second dose of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.2

Dose Preparation

Thawing Prior to Dilution

Thaw
  • Thaw vial(s) of the 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

  • ONLY use sterile 0.9% Sodium Chloride Injection, USP 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 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 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 the Vaccine

Draw Dose

Cleanse

  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the 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 a single 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 vaccine intramuscularly.

After dilution, vials of the 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

    Indication & Authorized Use

    Important Safety Information

    • Known history of a severe allergic reaction (eg, anaphylaxis) to any component of COMIRNATY® is a contraindication.
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

      Monitor 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).

    • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
    • Syncope (fainting) may occur in association with administration of injectable vaccines, including this vaccine. 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 vaccine.
    • The vaccine may not protect all vaccine recipients.
    • In clinical studies of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).
    • In clinical studies of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
    • In a clinical study evaluating administration of a booster dose in participants 18 through 55 years of age, the most commonly reported adverse reactions (≥10%) following the dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%).
    • In a clinical study of adolescents 12 through 15 years of age, the most commonly reported adverse reactions 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%).
    • Before administration of the vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).
    • Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://vaers.hhs.gov/reportevent.html or call 1-800-822-7967.

    Indication & Authorized Use

    The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.


    Indication

    COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

    Authorized Use

    COMIRNATY® (COVID-19 Vaccine, mRNA) is also authorized for emergency use to provide:

    • a two-dose primary series in individuals 12 through 15 years
    • a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose in individuals:
      • 65 years of age and older
      • 18 through 64 years of age at high risk of severe COVID-19
      • 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

    The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 12 years of age and older to provide:

    • a two-dose primary series in individuals 12 years of age and older
    • a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose in individuals:
      • 65 years of age and older
      • 18 through 64 years of age at high risk of severe COVID-19
      • 18 through 64 years of age at risk of serious complications of COVID-19 in the setting of frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; 2021.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Pfizer and BioNTech; 2021.
  3. Data on File. Pfizer Inc. New York, NY.
  4. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  5. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

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