Label: PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2 injection, suspension

  • NDC Code(s): 59267-1055-1, 59267-1055-4
  • Packager: Pfizer Manufacturing Belgium NV
  • Category: VACCINE LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 30, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)

    EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

    FOR 5 THROUGH 11 YEARS OF AGE
    DILUTE BEFORE USE

    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older.

    This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with an orange cap and a label with an orange border, which MUST BE DILUTED PRIOR TO USE. The vial labels state: Age 5y to <12y. The carton labels state: For age 5 years to <12 years.

    Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with an orange cap and a label with an orange border is authorized for use to provide:

    • a 2-dose primary series to individuals 5 through 11 years of age.
    • a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise.1
    • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine.

    Pfizer-BioNTech COVID-19 Vaccine which is supplied in a multiple dose vial with an orange cap and a label with an orange border, should not be used in individuals 6 months through 4 years of age or individuals 12 years of age and older because of the potential for vaccine administration errors, including dosing error.2,3

    SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

    Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements.

    The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection.

    Primary Series

    The Pfizer-BioNTech COVID-19 Vaccine, which is supplied in a multiple dose vial with an orange cap and a label with an orange border, is administered, after dilution, as a primary series of 2 doses (0.2 mL each) 3 weeks apart in individuals 5 through 11 years of age.

    A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) at least 28 days following the second dose is authorized for administration to individuals 5 through 11 years of age with certain kinds of immunocompromise.

    Booster Dose

    A single Pfizer-BioNTech COVID-19 Vaccine booster dose supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) may be administered, after dilution, at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.

    See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com.

    For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov.

    DESCRIPTION OF COVID-19

    Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

    DOSAGE AND ADMINISTRATION

    The storage, preparation, and administration information in this Fact Sheet apply to the Pfizer-BioNTech COVID-19 Vaccine which is supplied in a multiple dose vial with an orange cap and a label with an orange border and MUST BE DILUTED before use.

    Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Orange Cap and a Label with an Orange Border
    Age RangeDilution InformationDoses Per Vial After DilutionDose Volume
    5 through 11 years
    (Vial labels state: Age 5y to <12y)
    Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection, USP prior to use100.2 mL

    Storage and Handling

    During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

    Do not refreeze thawed vials.

    Vial Storage Prior to Use

    Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may arrive frozen at ultra-cold conditions in thermal containers with dry ice.

    Once received, frozen vials may be immediately transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 4 hours to thaw at this temperature.

    Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.

    If cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders are received at 2°C to 8°C (35ºF to 46ºF), they should be stored at 2°C to 8°C (35ºF to 46ºF). Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

    Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 12 months from the date of the manufacture are shown below.

    Printed Manufacturing Date 12-Month Expiry Date
    07/202130-Jun-2022
    08/202131-Jul-2022
    09/202131-Aug-2022
    10/202130-Sep-2022
    11/202131-Oct-2022
    12/202130-Nov-2022
    01/202231-Dec-2022
    02/202231-Jan-2023

    Vial Storage During Use

    If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.

    Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to dilution.

    After dilution, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution.

    Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in this Fact Sheet supersedes the number of hours printed on vial labels and cartons.

    Transportation of Vials

    If local redistribution is needed, undiluted vials may be transported at -90°C to -60°C (-130°F to -76°F) or at 2°C to 8°C (35°F to 46°F).

    Dosing and Schedule

    Primary Series

    The Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders is administered intramuscularly as a primary series of 2 doses (0.2 mL each) 3 weeks apart to individuals 5 through 11 years of age.

    A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) at least 28 days following the second dose is authorized for administration to individuals 5 through 11 years of age with certain kinds of immunocompromise.

    Booster Dose

    A single Pfizer-BioNTech COVID-19 Vaccine booster dose supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.

    Dose Preparation

    Each vial MUST BE DILUTED before administering the vaccine.

    Prior to Dilution

    • The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with an orange cap and a label with an orange border contains a volume of 1.3 mL, and is supplied as a frozen suspension that does not contain preservative.
    • Each vial must be thawed before dilution.
      • Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)].
      • Refer to thawing instructions in the panels below.

    Dilution

    Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine.

    ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Do not add more than 1.3 mL of diluent.

    After dilution, 1 vial contains 10 doses of 0.2 mL.

    Dilution and Preparation Instructions
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border – VIAL VERIFICATION
    Figure Orange plastic cap and label with orange border.
    • Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has an orange plastic cap and a label with an orange border and states "Age 5y to < 12y."
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border – THAWING PRIOR TO DILUTION
    FigureStore in the refrigerator for up to 10 weeks prior to use.
    • Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by:
      • Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of 10 vials may take up to 4 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks.
      • Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes.
      • Vials may be stored at room temperature [up to 25ºC (77ºF)] for up to 12 hours prior to use.
    FigureGently × 10
    • Before dilution, mix by inverting 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 opaque amorphous particles.
    • Do not use if liquid is discolored or if other particles are observed.
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border – DILUTION
    FigureAdd 1.3 mL of sterile 0.9% sodium chloride injection, USP.
    • Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent.
    • Using aseptic technique, withdraw 1.3 mL of diluent into a transfer syringe (21-gauge or narrower needle).
    • Cleanse the vaccine vial stopper with a single-use antiseptic swab.
    • Add 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial.
    FigurePull back plunger to 1.3 mL to remove air from vial.
    • Equalize vial pressure before removing the needle from the vial by withdrawing 1.3 mL air into the empty diluent syringe.
    FigureGently × 10
    • 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 a white to off-white suspension. Do not use if vaccine is discolored or contains particulate matter.
    FigureRecord the date and time of dilution.
    Use within 12 hours after dilution.
    • 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 12 hours after dilution.
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border - WITHRAWAL OF INDIVIDUAL 0.2 mL DOSES
    FigureWithdraw 0.2 mL dose of vaccine.
    • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe and/or needle.
    • Each dose must contain 0.2 mL of vaccine.
    • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 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 a white to off-white suspension. During the visual inspection,

    • verify the final dosing volume of 0.2 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 with orange caps and labels with orange borders contain 10 doses of 0.2 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:

    • Each dose must contain 0.2 mL of vaccine.
    • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and content.
    • Do not pool excess vaccine from multiple vials.

    Contraindications

    Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information).

    Warnings

    Management of Acute Allergic Reactions

    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 (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

    Myocarditis and Pericarditis

    Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

    Syncope

    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.

    Altered Immunocompetence

    Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

    Limitation of Effectiveness

    Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

    Adverse Reactions

    Adverse Reactions in Clinical Trials

    Adverse reactions in children 5 through 11 years of age following administration of the Pfizer-BioNTech COVID-19 Vaccine included pain at the injection site, fatigue, headache, injection site redness, injection site swelling, muscle pain, chills, fever, joint pain, lymphadenopathy, nausea, rash, malaise, decreased appetite, diarrhea, and vomiting (see Full EUA Prescribing Information).

    Adverse Reactions Identified in Post Authorization Experience

    Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

    Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

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

    Use with Other Vaccines

    There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

    INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

    As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the "Fact Sheet for Recipients and Caregivers" (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of Pfizer-BioNTech COVID-19 Vaccine, including:

    • FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine.
    • The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine.
    • The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.
    • Information about available alternative vaccines and the risks and benefits of those alternatives.

    For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.

    Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 Vaccine.

    Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe.

    MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION4

    In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

    1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months of age and older.
    2. The vaccination provider must communicate to the individual receiving the Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information consistent with the "Fact Sheet for Recipients and Caregivers" prior to the individual receiving Pfizer-BioNTech COVID-19 Vaccine.
    3. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system.
    4. The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
      • vaccine administration errors whether or not associated with an adverse event,
      • serious adverse events* (irrespective of attribution to vaccination),
      • cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and
      • cases of COVID-19 that result in hospitalization or death.
      Complete and submit reports 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.
    5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine to recipients.

    * Serious adverse events are defined as:

    • Death;
    • A life-threatening adverse event;
    • Inpatient hospitalization or prolongation of existing hospitalization;
    • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
    • A congenital anomaly/birth defect;
    • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent 1 of the outcomes listed above.

    OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC.

    Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

    To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.

    WebsiteFax numberTelephone number
    www.pfizersafetyreporting.com1-866-635-83371-800-438-1985

    ADDITIONAL INFORMATION

    For general questions, visit the website or call the telephone number provided below.

    To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below.

    Global websiteTelephone number
    www.cvdvaccine.comImage1-877-829-2619
    (1-877-VAX-CO19)

    AVAILABLE ALTERNATIVES

    There may be clinical trials or availability under EUA of other COVID-19 vaccines.

    FEDERAL COVID-19 VACCINATION PROGRAM

    This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.

    Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or https://TIPS.HHS.GOV.

    AUTHORITY FOR ISSUANCE OF THE EUA

    The Secretary of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. In response, FDA has issued an EUA for the unapproved product, Pfizer-BioNTech COVID-19 Vaccine for active immunization against COVID-19.

    FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data.

    For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

    This EUA for the Pfizer-BioNTech COVID-19 Vaccine will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

    For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

    The Countermeasures Injury Compensation Program

    The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.

    Manufactured for
    BioNTech Manufacturing GmbH
    An der Goldgrube 12
    55131 Mainz, Germany

    Logo

    Manufactured by
    Pfizer Inc., New York, NY 10017

    LAB-1502-6.0

    Revised: 17 June 2022

    END SHORT VERSION FACT SHEET

    Long Version (Full EUA Prescribing Information) Begins On Next Page


    1
    Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
    2
    Notwithstanding the age limitations for use of the different formulations and presentations described above, individuals who will turn from 4 years to 5 years of age between any doses in the primary series may receive for any dose in the primary regimen, either: (1) the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA, supplied in multiple dose vials with orange caps). If individuals who will turn from 4 years to 5 years have initiated a 3-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age (each 0.2 mL dose containing 3 mcg modRNA, supplied in multiple dose vials with maroon caps), then doses 2 and 3 of the 3-dose primary series may be provided with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 years through 11 years of age (supplied in multiple dose vials with orange caps).
    3
    Notwithstanding the age limitations for use of the different formulations and presentations described above, individuals who will turn from 11 years to 12 years of age between doses in the primary regimen may receive, for any dose in the primary regimen, either: (1) the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA, supplied in multidose vials with orange caps); or (2) COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older (each 0.3 mL dose containing 30 mcg modRNA, supplied in multidose vials with gray caps and multidose vials with purple caps).
    4
    Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
  • SPL UNCLASSIFIED SECTION

    FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
    PFIZER-BIONTECH COVID-19 VACCINE
    FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*
    1
    AUTHORIZED USE
    2
    DOSAGE AND ADMINISTRATION
     
    2.1 Preparation for Administration
     
    2.2 Administration Information
     
    2.3 Vaccination Schedule
    3
    DOSAGE FORMS AND STRENGTHS
    4
    CONTRAINDICATIONS
    5
    WARNINGS AND PRECAUTIONS
     
    5.1 Management of Acute Allergic Reactions
     
    5.2 Myocarditis and Pericarditis
     
    5.3 Syncope
     
    5.4 Altered Immunocompetence
     
    5.5 Limitation of Effectiveness
    6
    OVERALL SAFETY SUMMARY
     
    6.1 Clinical Trials Experience
     
    6.2 Post Authorization Experience
    8
    REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS
    10
    DRUG INTERACTIONS
    11
    USE IN SPECIFIC POPULATIONS
     
    11.1 Pregnancy
     
    11.2 Lactation
     
    11.3 Pediatric Use
     
    11.4 Use in Immunocompromised
    13
    DESCRIPTION
    14
    CLINICAL PHARMACOLOGY
     
    14.1 Mechanism of Action
    18
    CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
     
    18.1 Efficacy of Primary Series in Participants 16 Years of Age and Older
     
    18.2 Efficacy of Primary Series in Children 5 Through 11 Years of Age
     
    18.3 Immunogenicity of Primary Series in Children 5 Through 11 Years of Age
     
    18.4 Immunogenicity of a Third Primary Series Dose in Individuals with Certain Kinds of Immunocompromise
     
    18.5 Immunogenicity of a Booster Dose Following a Pfizer-BioNTech COVID-19 Vaccine Primary Series in Children 5 Through 11 Years of Age
    19
    HOW SUPPLIED/STORAGE AND HANDLING
    20
    PATIENT COUNSELING INFORMATION
    21
    CONTACT INFORMATION
    * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed.
  • SPL UNCLASSIFIED SECTION

    FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

  • 1 AUTHORIZED USE

    Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

    This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. The vial labels state: Age 5y to <12y. The carton labels state: For age 5 years to <12 years.

  • 2 DOSAGE AND ADMINISTRATION

    For intramuscular injection only.

    The storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine, which is supplied in a multiple dose vial with an orange cap and a label with an orange border.

    Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Orange Cap and a Label with an Orange Border
    Age RangeDilution InformationDoses Per Vial After DilutionDose Volume
    5 through 11 years
    (Vial labels state: Age 5y to <12y)
    Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection, USP prior to use100.2 mL

    2.1 Preparation for Administration

    Each vial MUST BE DILUTED before administering the vaccine.

    Prior to Dilution

    • The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with an orange cap and a label with an orange border contains a volume of 1.3 mL, and is supplied as a frozen suspension that does not contain preservative.
    • Each vial must be thawed before dilution.
      • Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)].
      • Refer to thawing instructions in the panels below.

    Dilution

    • Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine.
    • ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Do not add more than 1.3 mL of diluent.
    • After dilution, 1 vial contains 10 doses of 0.2 mL.
    Dilution and Preparation Instructions
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border – VIAL VERIFICATION
    Figure
    Orange plastic cap and label with orange border.
    • Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has an orange plastic cap and a label with an orange border and states "Age 5y to < 12y.".
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border – THAWING PRIOR TO DILUTION
    FigureStore in the refrigerator for up to 10 weeks prior to use.
    • Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by:
      • Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of 10 vials may take up to 4 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks.
      • Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes.
      • Vials may be stored at room temperature [up to 25ºC (77ºF)] for 12 hours prior to use.
    FigureGently × 10
    • Before dilution, mix by inverting 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 opaque amorphous particles.
    • Do not use if liquid is discolored or if other particles are observed.
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border – DILUTION
    FigureAdd 1.3 mL of sterile 0.9% sodium chloride injection, USP.
    • Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent.
    • Using aseptic technique, withdraw 1.3 mL of diluent into a transfer syringe (21-gauge or narrower needle).
    • Cleanse the vaccine vial stopper with a single-use antiseptic swab.
    • Add 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial.
    FigurePull back plunger to 1.3 mL to remove air from vial.
    • Equalize vial pressure before removing the needle from the vial by withdrawing 1.3 mL air into the empty diluent syringe.
    FigureGently × 10
    • 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 a white to off-white suspension. Do not use if vaccine is discolored or contains particulate matter.
    FigureRecord the date and time of dilution.
    Use within 12 hours after dilution.
    • 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 12 hours after dilution.
    Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border – WITHRAWAL OF INDIVIDUAL 0.2 mL DOSES
    FigureWithdraw 0.2 mL dose of vaccine
    • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe and/or needle.
    • Each dose must contain 0.2 mL of vaccine.
    • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
    • Administer immediately.

    2.2 Administration Information

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

    • verify the final dosing volume of 0.2 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 with orange caps and labels with orange borders contain 10 doses of 0.2 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:

    • Each dose must contain 0.2 mL of vaccine.
    • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and content.
    • Do not pool excess vaccine from multiple vials.

    2.3 Vaccination Schedule

    Primary Series

    The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.2 mL each) 3 weeks apart in individuals 5 through 11 years of age.

    A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) at least 28 days following the second dose is authorized for administration to individuals 5 through 11 years of age with certain kinds of immunocompromise.5


    5
    Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

    Booster Dose

    A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.2 mL) may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.

  • 3 DOSAGE FORMS AND STRENGTHS

    Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection.

    After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders is 0.2 mL for individuals 5 through 11 years of age [see Dosage and Administration (2.1)].

  • 4 CONTRAINDICATIONS

    Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)].

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Management of Acute Allergic Reactions

    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 (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

    5.2 Myocarditis and Pericarditis

    Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

    5.3 Syncope

    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.

    5.4 Altered Immunocompetence

    Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

    5.5 Limitation of Effectiveness

    The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

  • 6 OVERALL SAFETY SUMMARY

    It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.6 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc.


    6
    Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

    Primary Series

    In a clinical study in children 5 through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine containing 10 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (10 mcg modRNA), adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

    Booster Dose

    In a clinical study in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).

    Post Authorization Experience

    Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

    Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    Primary Series

    The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 5 years of age and older in 3 clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America.

    Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Study C4591007 (Study 3) is a Phase 1/2/3 multicenter, randomized, dose-finding, open-label (Phase 1) and multinational, saline placebo-controlled, observer-blind, immunogenicity and efficacy (Phase 2/3) study that has enrolled 4,695 participants 5 through 11 years of age, of whom 3109 participants received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 1538 participants received placebo in Phase 2/3.

    In Study 2 and Study 3, all participants 5 through 11 years of age, 12 through 15 years of age, and 16 years of age and older in the reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) after the last vaccination or 6 months (serious adverse events) after the last vaccination]. Tables 1 and 2 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine (10 mcg modRNA) and placebo in children 5 through 11 years of age.

    Children 5 Through 11 Years of Age

    In an analysis of Study 3 Phase 2/3, based on data up to the cutoff date of September 06, 2021, 2,268 participants [1,518 Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA); 750 placebo] were 5 through 11 years of age. Of these, 2,158 (95.1%) [1,444 Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 714 placebo] participants have been followed for at least 2 months after the second dose. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants [1,591 Pfizer BioNTech COVID-19 Vaccine (10 mcg modRNA) and 788 placebo], of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2 up to the cutoff date of October 8, 2021. The safety evaluation in Study 3 is ongoing.

    Demographic characteristics in Study 3 were generally similar with regard to age, gender, race, and ethnicity among participants 5 through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and those who received placebo. Among the 4,647 participants 5 through 11 years of age who received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA), 51.8% were male and 48.2% were female, 77.3% were White, 5.8% were Black or African American, 16.9% were Hispanic/Latino, 8.3% were Asian, and 0.4% were American Indian/Alaska Native.

    Solicited Local and Systemic Adverse Reactions

    The mean duration of pain at the injection site after Dose 2 was 2.3 days (range 1 to 11 days), for redness 2.2 days (range 1 to 10 days), and for swelling 2.2 days (range 1 to 10 days) for children in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group up to the cutoff date of September 06, 2021.

    Table 1: Study 3 – Frequency and Percentages of Participants With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Children 5 Through 11 Years of Age – Safety Population*
    Pfizer-BioNTech COVID-19 Vaccine
    Dose 1
    N=1511
    n§ (%)
    Placebo
    Dose 1
    N,=748
    n§ (%)
    Pfizer-BioNTech COVID-19 Vaccine
    Dose 2
    N=1501
    n§ (%)
    Placebo
    Dose 2
    N,=740
    n§ (%)
    Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
    *
    Randomized participants who received at least 1 dose of the study intervention.
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
    §
    n = Number of participants with the specified reaction.
    The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error.
    #
    Mild: ≥0.5 to ≤2.0 cm; Moderate: >2.0 to ≤7.0 cm; Severe: >7.0 cm.
    Þ
    Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
    Redness#
      Any (≥0.5 cm)222 (14.7)43 (5.7)278 (18.5)40 (5.4)
        Mild143 (9.5)37 (4.9)143 (9.5)31 (4.2)
        Moderate79 (5.2)6 (0.8)132 (8.8)9 (1.2)
        Severe003 (0.2)0
    Swelling#
      Any (≥0.5 cm)158 (10.5)20 (2.7)229 (15.3)20 (2.7)
        Mild85 (5.6)13 (1.7)117 (7.8)15 (2.0)
        Moderate72 (4.8)7 (0.9)112 (7.5)5 (0.7)
        Severe1 (0.1)000
    Pain at the injection siteÞ
      Any1119 (74.1)234 (31.3)1065 (71.0)218 (29.5)
        Mild890 (58.9)204 (27.3)793 (52.8)192 (25.9)
        Moderate225 (14.9)30 (4.0)267 (17.8)26 (3.5)
        Severe4 (0.3)05 (0.3)0
    Table 2: Study 3 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Children 5 Through 11 Years of Age – Safety Population*
    Pfizer-BioNTech COVID-19 Vaccine
    Dose 1
    N=1511
    n§ (%)
    Placebo
    Dose 1
    N,=748
    n§ (%)
    Pfizer-BioNTech COVID-19 Vaccine
    Dose 2
    N=1501
    n§ (%)
    Placebo
    Dose 2
    N,=740
    n§ (%)
    Note: Events and use of antipyretic or pain medication were collected in an electronic diary (e-diary) from Day 1 to Day 7 after each dose.
    *
    Randomized participants who received at least 1 dose of the study intervention.
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
    §
    n = Number of participants with the specified reaction.
    The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error.
    #
    Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
    Þ
    Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
    ß
    Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
    à
    Severity was not collected for use of antipyretic or pain medication.
    Fever
      ≥38.0℃38 (2.5)10 (1.3)98 (6.5)9 (1.2)
      ≥38.0℃ to 38.4℃23 (1.5)4 (0.5)51 (3.4)5 (0.7)
      >38.4℃ to 38.9℃12 (0.8)5 (0.7)38 (2.5)3 (0.4)
      >38.9℃ to 40.0℃3 (0.2)1 (0.1)8 (0.5)1 (0.1)
      >40.0℃001 (0.1)0
    Fatigue#
      Any508 (33.6)234 (31.3)592 (39.4)180 (24.3)
        Mild333 (22.0)150 (20.1)321 (21.4)96 (13.0)
        Moderate171 (11.3)83 (11.1)260 (17.3)83 (11.2)
        Severe4 (0.3)1 (0.1)11 (0.7)1 (0.1)
    Headache#
      Any339 (22.4)180 (24.1)420 (28.0)138 (18.6)
        Mild249 (16.5)131 (17.5)281 (18.7)93 (12.6)
        Moderate88 (5.8)45 (6.0)136 (9.1)45 (6.1)
        Severe2 (0.1)4 (0.5)3 (0.2)0
    Chills#
      Any70 (4.6)35 (4.7)147 (9.8)32 (4.3)
        Mild54 (3.6)30 (4.0)105 (7.0)24 (3.2)
        Moderate16 (1.1)5 (0.7)40 (2.7)7 (0.9)
        Severe002 (0.1)1 (0.1)
    VomitingÞ
      Any33 (2.2)11 (1.5)28 (1.9)6 (0.8)
        Mild26 (1.7)11 (1.5)27 (1.8)6 (0.8)
        Moderate7 (0.5)01 (0.1)0
        Severe0000
    Diarrheaß
      Any89 (5.9)31 (4.1)79 (5.3)35 (4.7)
        Mild79 (5.2)31 (4.1)72 (4.8)32 (4.3)
        Moderate10 (0.7)07 (0.5)3 (0.4)
        Severe0000
    New or worsened muscle pain#
      Any137 (9.1)51 (6.8)175 (11.7)55 (7.4)
        Mild96 (6.4)35 (4.7)116 (7.7)38 (5.1)
        Moderate40 (2.6)16 (2.1)58 (3.9)17 (2.3)
        Severe1 (0.1)01 (0.1)0
    New or worsened joint pain#
      Any50 (3.3)41 (5.5)78 (5.2)27 (3.6)
        Mild34 (2.3)31 (4.1)57 (3.8)20 (2.7)
        Moderate16 (1.1)10 (1.3)21 (1.4)7 (0.9)
        Severe0000
    Use of antipyretic or pain medicationà217 (14.4)62 (8.3)296 (19.7)60 (8.1)

    Unsolicited Adverse Events

    In the following analyses of Study 3 in children 5 through 11 years of age (1,518 of whom received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 750 of whom received placebo), 99.5% of participants had at least 30 days of follow-up after Dose 2.

    Serious Adverse Events

    In 1 group of participants (initial enrollment cohort) with a median of 2.3 months follow-up post Dose 2, no serious adverse events were reported that were considered related to vaccination. In a second group of participants (expansion cohort) with a median of 2.4 weeks follow-up post Dose 2, no serious adverse events were reported that were considered related to vaccination.

    Non-Serious Adverse Events

    In 1 group of participants (initial enrollment cohort), non-serious adverse events from Dose 1 through up to 30 days after Dose 2 up to the cutoff date of September 06, 2021, in ongoing follow-up were reported by 10.9% of Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) recipients and by 9.1% of placebo recipients. In this group of participants, >99% had follow-up 30 days post Dose 2. In a second group of participants (expansion cohort) for which the median follow-up was 2.4 weeks (range 0 – 3.7 weeks), non-serious adverse events from Dose 1 through the cutoff date of October 8, 2021, were reported by 7.1% of Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) recipients and by 6.3% of placebo recipients.

    In the initial enrollment cohort, from Dose 1 through 30 days after Dose 2, lymphadenopathy was reported in 13 (0.9%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 1 (0.1%) in the placebo group. In the expansion cohort from Dose 1 through the cutoff date, lymphadenopathy was reported in 6 (0.4%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 3 (0.4%) in the placebo group. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

    Adolescents 12 Through 15 Years of Age

    In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents [1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo] were 12 through 15 years of age. Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least 2 months after the second dose. The safety evaluation in Study 2 is ongoing.

    Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native.

    Unsolicited Adverse Events

    In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had at least 30 days of follow-up after Dose 2.

    Serious Adverse Events

    Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

    Non-Serious Adverse Events

    Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

    Participants 16 Years of Age and Older

    At the time of the analysis of Study 2 for the EUA, 37,586 [18,801 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of 2 months after the second dose.

    The safety evaluation in Study 2 is ongoing. The safety population includes participants 16 years and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020.

    Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native.

    Unsolicited Adverse Events

    Serious Adverse Events

    In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2.

    Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

    Non-Serious Adverse Events

    In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. Overall in a similar analysis in which 7,960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2.

    The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

    Booster Dose Following a Primary Series of Pfizer-BioNTech COVID-19 Vaccine

    A subset of Phase 2/3 participants 5 through 11 years of age received a booster dose of Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) at least 5 months after completing the primary series (range 5 to 9 months, 86.8% of participants received the booster dose at least 8 months after Dose 2). Those participants vaccinated prior to February 22, 2022 provided the safety database (n=401), and had a median safety follow-up of 1.3 months from vaccination through the data cut-off date of March 22, 2022.

    The median age of these 401 participants was 8.0 years (range 5 through 11 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native.

    Solicited Local and Systemic Adverse Reactions

    Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of Pfizer-BioNTech COVID-19 Vaccine for Phase 2/3 participants 5 through 11 years of age.

    In participants who received a booster dose, the mean duration of pain at the injection site after the booster dose was 2.4 days (range 1 to 35 days), for redness 2.3 days (range 1 to 12 days), and for swelling 2.3 days (range 1 to 9 days).

    Table 3: Study 3 – Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of Pfizer-BioNTech COVID-19 Vaccine – Children 5 through 11 Years of Age – Safety Population*
    Pfizer-BioNTech COVID-19 Vaccine
    Booster
    N=371
    n§ (%)
    Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination.
    *
    Randomized participants who received at least 1 dose of the study intervention.
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
    §
    n = Number of participants with the specified characteristic.
    Mild: ≥0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm.
    #
    Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity.
    Redness
      Any (≥0.5 cm)58 (15.6)
        Mild38 (10.2)
        Moderate19 (5.1)
        Severe1 (0.3)
    Swelling
      Any (≥0.5 cm)61 (16.4)
        Mild30 (8.1)
        Moderate31 (8.4)
        Severe0
    Pain at the injection site#
      Any274 (73.9)
        Mild177 (47.7)
        Moderate95 (25.6)
        Severe2 (0.5)
    Table 4: Study 3 – Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of Pfizer-BioNTech COVID-19 Vaccine – Children 5 through 11 Years of Age – Safety Population*
    Solicited Systemic ReactionPfizer-BioNTech COVID-19 Vaccine
    Booster
    N=371
    n§ (%)
    Note: Events and use of antipyretic or pain medication were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination.
    *
    Randomized participants who received at least 1 dose of the study intervention.
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    N = number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
    §
    n = Number of participants with the specified characteristic.
    Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity.
    #
    Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration.
    Þ
    Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours.
    ß
    Severity was not collected for use of antipyretic or pain medication.
    Fever
      ≥38.0°C25 (6.7)
      ≥38.0°C to 38.4°C17 (4.6)
      >38.4°C to 38.9°C5 (1.3)
      >38.9°C to 40.0°C3 (0.8)
      >40.0°C0
    Fatigue
      Any169 (45.6)
        Mild99 (26.7)
        Moderate63 (17.0)
        Severe7 (1.9)
    Headache
      Any126 (34.0)
        Mild76 (20.5)
        Moderate47 (12.7)
        Severe0
    Chills
      Any39 (10.5)
        Mild23 (6.2)
        Moderate15 (4.0)
        Severe1 (0.3)
    Vomiting#
      Any9 (2.4)
        Mild6 (1.6)
        Moderate3 (0.8)
        Severe0
    DiarrheaÞ
      Any18 (4.9)
        Mild15 (4.0)
        Moderate2 (0.5)
        Severe1 (0.3)
    New or worsened muscle pain
      Any68 (18.3)
        Mild40 (10.8)
        Moderate28 (7.5)
        Severe0
    New or worsened joint pain
      Any25 (6.7)
        Mild14 (3.8)
        Moderate11 (3.0)
        Severe0
    Use of antipyretic or pain medicationß114 (30.7)

    Unsolicited Adverse Events

    Overall, the 401 participants who received a booster dose of Pfizer-BioNTech COVID-19 Vaccine had a median follow-up time of 1.3 months after the booster dose through the cutoff date.

    In an analysis of all unsolicited adverse events reported in participants 5 through 11 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions.

    Serious Adverse Events

    No serious adverse events were reported after the booster dose through the cutoff date.

    6.2 Post Authorization Experience

    The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

    Cardiac Disorders: myocarditis, pericarditis

    Gastrointestinal Disorders: diarrhea, vomiting

    Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)

    Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)

    Nervous System Disorders: syncope

  • 8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS7

    See Overall Safety Summary (Section 6) for additional information.

    The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS):

    • Vaccine administration errors whether or not associated with an adverse event
    • Serious adverse events* (irrespective of attribution to vaccination)
    • Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults
    • Cases of COVID-19 that result in hospitalization or death

    *Serious adverse events are defined as:

    • Death
    • A life-threatening adverse event
    • Inpatient hospitalization or prolongation of existing hospitalization
    • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    • A congenital anomaly/birth defect
    • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent 1 of the outcomes listed above

    Instructions for Reporting to VAERS

    The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using 1 of the following methods:

    • Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
    • If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to info@vaers.org.

    IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include:

    • Patient demographics (e.g., patient name, date of birth)
    • Pertinent medical history
    • Pertinent details regarding admission and course of illness
    • Concomitant medications
    • Timing of adverse event(s) in relationship to administration of the Pfizer-BioNTech COVID-19 Vaccine
    • Pertinent laboratory and virology information
    • Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

    The following steps are highlighted to provide the necessary information for safety tracking:

    1. In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within 1 month prior.
    2. In Box 18, description of the event:
      a.
      Write "Pfizer-BioNTech COVID-19 Vaccine EUA" as the first line.
      b.
      Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above.
    3. Contact information:
      a.
      In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.
      b.
      In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.
      c.
      In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider's office address).

    Other Reporting Instructions

    Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

    To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.

    WebsiteFax numberTelephone number
    www.pfizersafetyreporting.com1-866-635-83371-800-438-1985

    7
    Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
  • 10 DRUG INTERACTIONS

    There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

  • 11 USE IN SPECIFIC POPULATIONS

    11.1 Pregnancy

    Risk Summary

    All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

    In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.

    11.2 Lactation

    Risk Summary

    Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

    11.3 Pediatric Use

    Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. This authorization is based on safety and effectiveness data in this age group and adults.

    Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals younger than 6 months of age.

    11.4 Use in Immunocompromised

    Safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine in children with immunocompromise has been extrapolated from adult data. An independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med) described the safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine in adult persons that received solid organ transplants. In this report describing 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status.

  • 13 DESCRIPTION

    The Pfizer-BioNTech COVID-19 Vaccine in multiple dose vials with orange caps and labels with orange borders is supplied as a frozen suspension; each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders contains 10 mcg of modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2.

    Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine hydrochloride. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium chloride per dose.

    The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with natural rubber latex.

  • 14 CLINICAL PHARMACOLOGY

    14.1 Mechanism of Action

    The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.

  • 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

    18.1 Efficacy of Primary Series in Participants 16 Years of Age and Older

    Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).

    In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) or placebo separated by 21 days. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.

    The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Table 5 presents the specific demographic characteristics in the studied population.

    Table 5: Demographics (population for the primary efficacy endpoint)*
    Pfizer-BioNTech COVID-19 Vaccine
    (N=18,242)
    n (%)
    Placebo
    (N=18,379)
    n (%)
    *
    All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no other important protocol deviations as determined by the clinician, and have no evidence of SARS-CoV-2 infection prior to 7 days after Dose 2.
    Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
    100 participants 12 through 15 years of age with limited follow-up in the randomized population received at least 1 dose (49 in the vaccine group and 51 in the placebo group). Some of these participants were included in the efficacy evaluation depending on the population analyzed. They contributed to exposure information but with no confirmed COVID-19 cases, and did not affect efficacy conclusions.
    §
    Includes multiracial and not reported.
    Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease
    • Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or moderate to severe asthma
    • Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension)
    • Obesity (body mass index ≥30 kg/m2)
    • Diabetes (Type 1, Type 2 or gestational)
    • Liver disease
    • Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation)
    Sex
      Male9318 (51.1)9225 (50.2)
      Female8924 (48.9)9154 (49.8)
    Age (years)
      Mean (SD)50.6 (15.70)50.4 (15.81)
      Median52.052.0
      Min, max(12, 89)(12, 91)
    Age group
      ≥12 through 15 years46 (0.3)42 (0.2)
      ≥16 through 17 years66 (0.4)68 (0.4)
      ≥16 through 64 years14,216 (77.9)14,299 (77.8)
      ≥65 through 74 years3176 (17.4)3226 (17.6)
      ≥75 years804 (4.4)812 (4.4)
    Race
      White15,110 (82.8)15,301 (83.3)
      Black or African American1617 (8.9)1617 (8.8)
      American Indian or Alaska Native118 (0.6)106 (0.6)
      Asian815 (4.5)810 (4.4)
      Native Hawaiian or other Pacific Islander48 (0.3)29 (0.2)
      Other§534 (2.9)516 (2.8)
    Ethnicity
      Hispanic or Latino4886 (26.8)4857 (26.4)
      Not Hispanic or Latino13,253 (72.7)13,412 (73.0)
      Not reported103 (0.6)110 (0.6)
    Comorbidities
      Yes8432 (46.2)8450 (46.0)
      No9810 (53.8)9929 (54.0)

    The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began enrollment from October 15, 2020.

    The vaccine efficacy information is presented in Table 6.

    Table 6: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup – Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population
    Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
    *
    Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
    Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
    N = Number of participants in the specified group.
    §
    Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
    n2 = Number of participants at risk for the endpoint.
    #
    n1 = Number of participants meeting the endpoint definition.
    Þ
    No confirmed cases were identified in adolescents 12 through 15 years of age.
    ß
    Credible interval for vaccine efficacy (VE) was calculated using a beta-binomial model with a beta (0.700102, 1) prior for θ=r(1-VE)/(1+r(1-VE)), where r is the ratio of surveillance time in the active vaccine group over that in the placebo group.
    à
    Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance time.
    First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*
    SubgroupPfizer-BioNTech COVID-19 Vaccine
    N=18,198
    Cases
    n1#
    Surveillance Time§ (n2)
    Placebo
    N=18,325
    Cases
    n1#
    Surveillance Time§ (n2)
    Vaccine Efficacy %
    (95% CI)
    All subjectsÞ8
    2.214 (17,411)
    162
    2.222 (17,511)
    95.0
    (90.3, 97.6)ß
      16 through 64 years7
    1.706 (13,549)
    143
    1.710 (13,618)
    95.1
    (89.6, 98.1)à
      65 years and older1
    0.508 (3848)
    19
    0.511 (3880)
    94.7
    (66.7, 99.9)à
    First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection
    SubgroupPfizer-BioNTech COVID-19 Vaccine
    N=19,965
    Cases
    n1#
    Surveillance Time§ (n2)
    Placebo
    N=20,172
    Cases
    n1#
    Surveillance Time§ (n2)
    Vaccine Efficacy %
    (95% CI)
    All subjectsÞ9
    2.332 (18,559)
    169
    2.345 (18,708)
    94.6
    (89.9, 97.3)ß
      16 through 64 years8
    1.802 (14,501)
    150
    1.814 (14,627)
    94.6
    (89.1, 97.7)à
      65 years and older1
    0.530 (4044)
    19
    0.532 (4067)
    94.7
    (66.8, 99.9)à

    18.2 Efficacy of Primary Series in Children 5 Through 11 Years of Age

    A descriptive efficacy analysis of Study 3 has been performed in 1,968 children 5 through 11 years of age without evidence of infection prior to 7 days after Dose 2. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cutoff date of October 8, 2021.

    Table 7 presents the specific demographic characteristics in participants who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose.

    Table 7: Demographics Characteristics – Participants Without Evidence of Infection Prior to 7 Days After Dose 2 – Phase 2/3 – 5 Through 11 Years of Age – Evaluable Efficacy Population
    Pfizer-BioNTech COVID-19 Vaccine*
    10 mcg/Dose
    (N=1305)
    n (%)
    Placebo
    (N=663)
    n (%)
    *
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    N = number of participants in the specified group from the evaluable efficacy population with no evidence of SARS CoV-2 infection prior to 7 days after Dose 2. This value is the denominator for the percentage calculations. Evaluable efficacy population included all eligible randomized participants who received all vaccination(s) as randomized within the predefined window, had no other important protocol deviations as determined by the clinician.
    n = Number of participants with the specified characteristic.
    §
    Includes multiracial and not reported.
    Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease: defined as participants who had at least 1 of the prespecified comorbidities based on MMWR 69(32);1081–1088 and/or obesity (BMI ≥ 95th percentile).
    Sex
      Male679 (52.0)343 (51.7)
      Female626 (48.0)320 (48.3)
    Age at Vaccination
      Mean (SD)8.2 (1.93)8.1 (1.98)
      Median8.08.0
      Min, max(5, 11)(5, 11)
    Race
      White1018 (78.0)514 (77.5)
      Black or African American76 (5.8)48 (7.2)
      American Indian or Alaska Native<1.0%<1.0%
      Asian86 (6.6)46 (6.9)
      Native Hawaiian or other Pacific Islander<1.0%<1.0%
      Other§110 (8.4)52 (7.8)
    Ethnicity
      Hispanic or Latino243 (18.6)130 (19.6)
      Not Hispanic or Latino1059 (81.1)533 (80.4)
      Not reported<1.0%<1.0%
    Comorbidities
      Yes262 (20.1)133 (20.1)
      No1043 (79.9)530 (79.9)

    The descriptive vaccine efficacy results in children 5 through 11 years of age without evidence of prior SARS-CoV-2 infection are presented in Table 8. None of the cases accrued met criteria for severe COVID-19 or multisystem inflammatory syndrome in children (MIS-C). No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.

    Table 8: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection Prior to 7 Days After Dose 2 – Phase 2/3 –Children 5 Through 11 Years of Age Evaluable Efficacy Population
    First COVID-19 occurrence from 7 days after Dose 2 in children 5 through 11 years of age without evidence of prior SARS-CoV-2 infection*
    Pfizer-BioNTech COVID-19 Vaccine
    10 mcg/dose
    N=1305
    Cases
    n1§
    Surveillance Time (n2#)
    Placebo
    N=663
    Cases
    n1§
    Surveillance Time (n2#)
    Vaccine Efficacy %
    (95% CI)
    Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
    *
    Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    N = Number of participants in the specified group.
    §
    n1 = Number of participants meeting the endpoint definition.
    Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
    #
    n2 = Number of participants at risk for the endpoint.
    Children 5 through 11 years of age3
    0.322 (1273)
    16
    0.159 (637)
    90.7
    (67.7, 98.3)

    18.3 Immunogenicity of Primary Series in Children 5 Through 11 Years of Age

    SARS-CoV-2 50% neutralizing antibody titers (NT50) 1 month after the primary series were compared between randomly selected subsets of Phase 2/3 participants 5 through 11 years of age from study C4591007 and the efficacy study C4591001 Phase 2/3 participants 16 through 25 years of age, using a microneutralization assay against the reference strain (USA_WA1/2020). The primary immunobridging analyses compared the geometric mean titers (using a geometric mean ratio [GMR]) and the seroresponse (defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 in each group. The prespecified immunobridging criteria were met for both the GMR and the seroresponse difference (Table 9 and Table 10).

    Table 9: SARS-CoV-2 GMTs (NT50) at 1 Month After Primary Series – Immunobridging Subset - Participants 5 Through 11 Years of Age (Study 3) and Participants 16 Through 25 Years of Age (Study 2) – Without Evidence of SARS-CoV-2 Infection up to 1 Month After Dose 2 – Evaluable Immunogenicity Population
    Pfizer-BioNTech COVID-19 VaccineGMT Ratio (95%CI)
    (5 Through 11 Years of Age/ 16 Through 25 Years of Age)*,
    10 mcg/Dose
    5 Through 11 Years of Age
    n§=264
    30 mcg/Dose
    16 Through 25 Years of Age
    n§=253
    AssayTime Point#GMTÞ
    (95% CIÞ)
    GMTÞ
    (95% CIÞ)
    Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
    Note: Participants who had no serological or virological evidence (up to 1 month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at pre-Dose 1 and 1 month after Dose 2, SARS-CoV-2 not detected by NAAT [nasal swab] at pre-Dose 1 and pre-Dose 2, and negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 blood collection) and had no medical history of COVID-19 were included in the analysis.
    *
    GMT ratio and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (5 through 11 years of age minus 16 through 25 years of age]) and the corresponding CI (based on the Student t distribution).
    Immunobridging is declared if the lower bound of the 2-sided 95% CI for the GMT ratio is greater than 0.67 and the point estimate of the GMR is ≥0.8.
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    §
    n = Number of participants with valid and determinate assay results for the specified assay at the given dose/sampling time point.
    Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
    #
    Protocol-specified timing for blood sample collection.
    Þ
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
    ß
    SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.
    SARS-CoV-2 neutralization assay - NT50 (titer)ß1 month after Dose 21197.6
    (1106.1, 1296.6)
    1146.5
    (1045.5, 1257.2)
    1.04
    (0.93, 1.18)
    Table 10: Difference in Percentages of Participants with Seroresponse at 1 Month After Primary Series – Immunobridging Subset –Participants 5 Through 11 Years of Age (Study 3) and Participants 16 Through 25 Years of Age (Study 2) Without Evidence of Infection up to 1 Month After Dose 2 – Evaluable Immunogenicity Population
    Pfizer-BioNTech COVID-19 VaccineDifference in Seroresponse Rates %* (95% CI)
    (5 Through 11 Years of Age minus 16 Through 25 Years of Age)
    10 mcg/Dose§
    5 Through 11 Years of Age
    N=264
    30 mcg/Dose#
    16 Through 25 Years of Age
    N=253
    AssayTime PointÞnß (%)
    (95% CIà)
    nß (%)
    (95% CIà)
    Abbreviations: LLOQ = lower limit of quantitation; NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2 nucleoprotein–binding; NT50 = 50% neutralizing titer 50; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
    Note: Seroresponse is defined as achieving a ≥4-fold rise from baseline (before Dose 1). If the baseline measurement is below the LLOQ, a postvaccination assay result ≥4 × LLOQ is considered a seroresponse
    Note: Participants who had no serological or virological evidence (up to 1 month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at pre-Dose 1 and 1 month after Dose 2, SARS-CoV-2 not detected by NAAT [nasal swab] at pre-Dose 1 and pre-Dose 2, and negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 blood collection) and had no medical history of COVID-19 were included in the analysis
    *
    Difference in proportions, expressed as a percentage (5 through 11 years of age minus 16 through 25 years of age).
    2-Sided CI, based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
    Immunobridging is declared if the lower bound of the 2-sided 95% CI for the difference in proportions is greater than -10.0% provided that the immunobridging criteria based on GMR were met.
    §
    Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
    N = number of participants with valid and determinate assay results both before vaccination and at 1 month after Dose 2. These values are the denominators for the percentage calculations.
    #
    Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
    Þ
    Protocol-specified timing for blood sample collection.
    ß
    n = Number of participants with seroresponse for the given assay at the given dose/sampling time point.
    à
    Exact 2-sided CI based on the Clopper and Pearson method.
    è
    SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.
    SARS-CoV-2 neutralization assay - NT50 (titer)è1 month after Dose 2262 (99.2)
    (97.3, 99.9)
    251 (99.2)
    (97.2, 99.9)
    0.0
    (-2.0, 2.2)

    18.4 Immunogenicity of a Third Primary Series Dose in Individuals with Certain Kinds of Immunocompromise

    Immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children with immunocompromise has been extrapolated from adult data. From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med), a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously. A third dose of the Pfizer-BioNTech COVID-19 Vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. All 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. The prevalence of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose.

    18.5 Immunogenicity of a Booster Dose Following a Pfizer-BioNTech COVID-19 Vaccine Primary Series in Children 5 Through 11 Years of Age

    In Study 3, immunogenicity of a booster dose administered at 7 to 9 months after the second primary series dose was evaluated in 67 study participants 5 through 11 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after the booster dose. Using a microneutralization assay against the reference strain of SARS-CoV-2 (USA_WA1/2020), the NT50 GMT at 1 month after the booster dose (2720.9 [95% CI: 2280.1, 3247.0]) was increased compared to before the booster dose (271.0 [95% CI: 229.1, 320.6]). Using a non-validated fluorescence focus reduction neutralization test assay against the Omicron variant of SARS-CoV-2 (B.1.1.529), the NT50 GMT at 1 month after the booster dose among a subset of 17 study participants (614.4 [95% CI: 410.7, 919.2]) was increased compared to the NT50 GMT at 1 month after dose 2 among a subset of 29 study participants (27.6 [95% CI: 22.1, 34.5]).

  • 19 HOW SUPPLIED/STORAGE AND HANDLING

    The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with orange caps and labels with orange borders. These multiple dose vials are supplied in a carton containing 10 multiple dose vials (NDC 59267-1055-4). After dilution, 1 vial contains 10 doses of 0.2 mL.

    During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

    Do not refreeze thawed vials.

    Vial Storage Prior to Use

    Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may arrive frozen at ultra-cold conditions in thermal containers with dry ice.

    Once received, frozen vials may be immediately transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 4 hours to thaw at this temperature.

    Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.

    If cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders are received at 2°C to 8°C (35ºF to 46ºF), they should be stored at 2°C to 8°C (35ºF to 46ºF). Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

    Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 12 months from the date of the manufacture are shown below.

    Printed Manufacturing Date 12-Month Expiry Date
    07/202130-Jun-2022
    08/202131-Jul-2022
    09/202131-Aug-2022
    10/202130-Sep-2022
    11/202131-Oct-2022
    12/202130-Nov-2022
    01/202231-Dec-2022
    02/202231-Jan-2023

    Vial Storage During Use

    If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.

    Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to dilution. After dilution, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution.

    Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in this Full EUA Prescribing Information supersedes the number of hours printed on vial labels and cartons.

    Transportation of Vials

    If local redistribution is needed, undiluted vials may be transported at -90°C to -60°C (-130°F to -76°F) or at 2°C to 8°C (35°F to 46°F).

  • 20 PATIENT COUNSELING INFORMATION

    Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.

    The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.

  • 21 CONTACT INFORMATION

    For general questions, visit the website or call the telephone number provided below.

    WebsiteTelephone number

    www.cvdvaccine.com

    Image

    1-877-829-2619
    (1-877-VAX-CO19)

    This Full EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com.

  • SPL UNCLASSIFIED SECTION

    Manufactured for
    BioNTech Manufacturing GmbH
    An der Goldgrube 12
    55131 Mainz, Germany

    Logo

    Manufactured by
    Pfizer Inc., New York, NY 10017

    LAB-1503-6.0

    Revised: 17 June 2022

  • INFORMATION FOR PATIENTS

    FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 5 THROUGH 11 YEARS OF AGE

    FOR 5 THROUGH 11 YEARS OF AGE

    Your child is being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.

    This Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 through 11 years of age.8,9

    The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide:

    • a two-dose primary series to individuals 5 through 11 years of age.
    • a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise.
    • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine.

    This Fact Sheet contains information to help you understand the risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, which your child may receive because there is currently a pandemic of COVID-19. Talk to your child's vaccination provider if you have questions.

    This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com.

    WHAT YOU NEED TO KNOW BEFORE YOUR CHILD GETS THIS VACCINE

    WHAT IS COVID-19?

    COVID-19 disease is caused by a coronavirus called SARS-CoV-2. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

    For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" section at the end of this Fact Sheet.

    WHAT SHOULD YOU MENTION TO YOUR CHILD'S VACCINATION PROVIDER BEFORE YOUR CHILD GETS THE VACCINE?

    Tell the vaccination provider about all of your child's medical conditions, including if your child:

    • has any allergies
    • has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
    • has a fever
    • has a bleeding disorder or is on a blood thinner
    • is immunocompromised or is on a medicine that affects your child's immune system
    • is pregnant
    • is breastfeeding
    • has received another COVID-19 vaccine
    • has ever fainted in association with an injection

    HOW IS THE VACCINE GIVEN?

    The Pfizer-BioNTech COVID-19 Vaccine will be given to your child as an injection into the muscle.

    Primary Series

    The vaccine is administered as a two-dose series, 3 weeks apart. A third primary series dose may be administered at least 28 days after the second dose to individuals with certain kinds of immunocompromise.

    Booster Dose

    A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.

    The vaccine may not protect everyone.

    WHO SHOULD NOT GET THE VACCINE?

    Your child should not get the vaccine if your child:

    • had a severe allergic reaction after a previous dose of this vaccine
    • had a severe allergic reaction to any ingredient of this vaccine.

    WHAT ARE THE INGREDIENTS IN THE VACCINE?

    The vaccine includes the following ingredients: mRNA, lipids (((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, sucrose, and sodium chloride.

    HAS THE VACCINE BEEN USED BEFORE?

    Millions of individuals 12 years of age and older have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. In a clinical trial, approximately 3,100 individuals 5 through 11 years of age have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. In other clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the vaccine. The vaccine that is authorized for use in children 5 through 11 years of age includes the same mRNA and lipids but different inactive ingredients compared to the vaccine that has been studied in clinical trials. The use of the different inactive ingredients helps stabilize the vaccine under refrigerated temperatures.

    WHAT ARE THE BENEFITS OF THE VACCINE?

    The vaccine has been shown to prevent COVID-19.

    The duration of protection against COVID-19 is currently unknown.

    WHAT ARE THE RISKS OF THE VACCINE?

    There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your child's vaccination provider may ask your child to stay at the place where your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

    • Difficulty breathing
    • Swelling of the face and throat
    • A fast heartbeat
    • A bad rash all over the body
    • Dizziness and weakness

    Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low. You should seek medical attention right away if your child has any of the following symptoms after receiving the vaccine:

    • Chest pain
    • Shortness of breath
    • Feelings of having a fast-beating, fluttering, or pounding heart

    Side effects that have been reported with the vaccine include:

    • Severe allergic reactions
    • Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
    • Myocarditis (inflammation of the heart muscle)
    • Pericarditis (inflammation of the lining outside the heart)
    • Injection site pain
    • Tiredness
    • Headache
    • Muscle pain
    • Chills
    • Joint pain
    • Fever
    • Injection site swelling
    • Injection site redness
    • Nausea
    • Feeling unwell
    • Swollen lymph nodes (lymphadenopathy)
    • Decreased appetite
    • Diarrhea
    • Vomiting
    • Arm pain
    • Fainting in association with injection of the vaccine

    These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.

    WHAT SHOULD I DO ABOUT SIDE EFFECTS?

    If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

    Call the vaccination provider or your child's healthcare provider if your child has any side effects that bother your child or do not go away.

    Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include "Pfizer-BioNTech COVID-19 Vaccine EUA" in the first line of box #18 of the report form.

    In addition, you can report side effects to Pfizer Inc. at the contact information provided below.

    WebsiteFax numberTelephone number
    www.pfizersafetyreporting.com1-866-635-83371-800-438-1985

    You may also be given an option to enroll in v-safe. V-safe is a voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

    WHAT IF I DECIDE NOT TO HAVE MY CHILD GET THE PFIZER-BIONTECH COVID-19 VACCINE?

    Under the EUA, there is an option to accept or refuse receiving the vaccine. Should you decide for your child not to receive it, it will not change your child's standard medical care.

    ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES PFIZER-BIONTECH COVID-19 VACCINE?

    Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

    CAN MY CHILD RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE AT THE SAME TIME AS OTHER VACCINES?

    Data have not yet been submitted to FDA on administration of the Pfizer-BioNTech COVID-19 Vaccine at the same time with other vaccines. If you are considering to have your child receive the Pfizer-BioNTech COVID-19 Vaccine with other vaccines, discuss the options with your child's healthcare provider.

    WHAT IF MY CHILD IS IMMUNOCOMPROMISED?

    If your child is immunocompromised, you may be given the option to have your child receive a third primary series dose of the vaccine. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to have your child maintain physical precautions to help prevent COVID-19. In addition, your child's close contacts should be vaccinated as appropriate. In addition, your child may receive a single booster dose after completion of the primary series.

    WHAT ABOUT PREGNANCY OR BREASTFEEDING?

    If your child is pregnant or breastfeeding, discuss the options with your healthcare provider.

    WILL THE VACCINE GIVE MY CHILD COVID-19?

    No. The vaccine does not contain SARS-CoV-2 and cannot give your child COVID-19.

    KEEP YOUR CHILD'S VACCINATION CARD

    When your child gets the first dose, you will get a vaccination card to show when to return for your child's next dose(s) of the vaccine. Remember to bring the card when your child returns.

    ADDITIONAL INFORMATION

    If you have questions, visit the website or call the telephone number provided below.

    To access the most recent Fact Sheets, please scan the QR code provided below.

    Global websiteTelephone number
    www.cvdvaccine.com
    Image
    1-877-829-2619
    (1-877-VAX-CO19)

    HOW CAN I LEARN MORE?

    • Ask the vaccination provider.
    • Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
    • Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    • Contact your local or state public health department.

    WHERE WILL MY CHILD'S VACCINATION INFORMATION BE RECORDED?

    The vaccination provider may include your child's vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. This will ensure that your child receives the same vaccine when your child returns for the second dose. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

    CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19 VACCINE?

    No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients).

    WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?

    Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or https://TIPS.HHS.GOV.

    WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?

    The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

    WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

    An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product.

    FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow the product to be used during the COVID-19 pandemic.

    An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used).

    Manufactured for
    BioNTech Manufacturing GmbH
    An der Goldgrube 12
    55131 Mainz, Germany

    Logo

    Manufactured by
    Pfizer Inc., New York, NY 10017

    LAB-1486-6.0

    Revised: 28 June 2022

    Image

    Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems.
    GDTI: 0886983000424

    8
    You may receive this Fact Sheet even if your child is 4 years old. Children who will turn from 4 years to 5 years of age between any doses in the primary series may receive a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age. Children who will turn from 4 years to 5 years of age between any doses in the primary series, and who initiated a 3-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, may receive the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age for doses 2 and/or 3.
    9
    You may receive this Fact Sheet even if your child is 12 years old. Children who will turn from 11 years to 12 years of age between doses in the primary regimen may receive, for any dose in the primary series, either: (1) the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age; or (2) COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older.
  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label

    Pfizer-BioNTech COVID-19 Vaccine
    Age 5y to < 12y

    DILUTE PRIOR TO USE
    After dilution - 10 doses of 0.2 mL

    For intramuscular use. Contains no preservative.
    For use under Emergency Use Authorization.
    After dilution store at 2 to 25°C (35 to 77°F) and
    discard after 6 hours.
    Dilution date and time:

    PAA178294

    LOT/MFG

    NDC 59267-1055-1

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton

    Pfizer-BioNTech
    COVID-19 Vaccine

    NDC 59267-1055-4

    Suspension for Intramuscular Injection

    DILUTE PRIOR TO USE

    10 Multiple Dose Vials

    After dilution each vial contains
    10 doses of 0.2 mL

    For age 5 years to < 12 years

    BIONTECH
    Pfizer
    Rx only

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    PFIZER-BIONTECH COVID-19 VACCINE 
    bnt162b2 injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:59267-1055
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN130 ug  in 2.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H) 0.23 mg  in 2.6 mL
    ((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V) 1.86 mg  in 2.6 mL
    TROMETHAMINE (UNII: 023C2WHX2V) 0.26 mg  in 2.6 mL
    TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) 1.71 mg  in 2.6 mL
    SUCROSE (UNII: C151H8M554) 133.9 mg  in 2.6 mL
    1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) 0.4 mg  in 2.6 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) 0.81 mg  in 2.6 mL
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 11.7 mg  in 2.6 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59267-1055-410 in 1 CARTON
    1NDC:59267-1055-12.6 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EMERGENCY USE AUTHORIZATION10/30/2021
    Labeler - Pfizer Manufacturing Belgium NV (370156507)
    Registrant - Pfizer Inc (113480771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Manufacturing Belgium NV370156507ANALYSIS(59267-1055) , MANUFACTURE(59267-1055) , PACK(59267-1055) , LABEL(59267-1055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC174350868ANALYSIS(59267-1055) , API MANUFACTURE(59267-1055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Inc004954111ANALYSIS(59267-1055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Ireland Pharmaceuticals985586408ANALYSIS(59267-1055)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioNTech Innovative Manufacturing Services GmbH537365801ANALYSIS(59267-1055)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioNTech Manufacturing GmbH314382536ANALYSIS(59267-1055) , API MANUFACTURE(59267-1055)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioNTech Manufacturing Marburg GmbH313270335ANALYSIS(59267-1055) , API MANUFACTURE(59267-1055)