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 6 MONTHS THROUGH 4 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 a maroon cap and a label with a maroon border, which MUST BE DILUTED PRIOR TO USE.

The vial labels may state "Age 2y to < 5y" or "Age 6m to < 5y" and carton labels may state "For age 2 years to < 5 years" or "For age 6 months to < 5 years". Vials with either printed age range can be used for individuals 6 months through 4 years of age.

Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a maroon cap and a label with a maroon border is authorized for use to provide a 3-dose primary series to individuals 6 months through 4 years of age.

Pfizer-BioNTech COVID-19 Vaccine, which is supplied in a multiple dose vial with a maroon cap and a label with a maroon border, should not be used in individuals 5 years of age and older because of the potential for vaccine administration errors, including dosing errors.1

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 myocarditis, cases of pericarditis, 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.

The Pfizer-BioNTech COVID-19 Vaccine for individuals 6 months through 4 years of age is supplied in a multiple dose vial with a maroon cap and a label with a maroon border. The Pfizer-BioNTech COVID-19 Vaccine is administered, after dilution, as a primary series of 3 doses (0.2 mL each). The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose in individuals 6 months through 4 years of age.

Individuals 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 (each 0.2 mL dose containing 10 mcg modRNA, supplied in multiple dose vials with orange caps and labels with orange borders)
  OR
• a 3-dose primary series initiated 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). Each of Doses 2 and 3 may be with:
  • Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age (supplied in multiple dose vials with maroon caps), or
  • 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 and labels with orange borders).

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 to prevent 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 a maroon cap and a label with a maroon border and MUST BE DILUTED before use.

Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Maroon Cap and a Label with a Maroon Border

Age Range	Dilution Information	Doses Per Vial After Dilution	Dose Volume
* The vial labels may state "Age 2y to < 5y" or "Age 6m to < 5y" and carton labels may state "For age 2 years to < 5 years" or "For age 6 months to < 5 years". Vials with either printed age range can be used for individuals 6 months through 4 years of age.
6 months through 4 years*	Dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use	10	0.2 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 maroon caps and labels with maroon 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 [2°C to 8°C (35°F to 46°F)], 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 2 hours to thaw at this temperature.

Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F) 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 maroon caps and labels with maroon borders are received at 2°C to 8°C (35°F to 46°F), they should be stored at 2°C to 8°C (35°F to 46°F). 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
01/2022		31-Dec-2022
02/2022		31-Jan-2023
03/2022		28-Feb-2023
04/2022		31-Mar-2023
05/2022		30-Apr-2023
06/2022		31-May-2023

Vial Storage During Use

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

Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with maroon caps and labels with maroon 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, even though some vial and carton labels may state that a vial should be discarded 6 hours after dilution. The information in this Fact Sheet supersedes the information 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

The Pfizer-BioNTech COVID-19 Vaccine for individuals 6 months through 4 years of age is supplied in multiple dose vials with maroon caps and labels with maroon borders. The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 3 doses (0.2 mL each) The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose in individuals 6 months through 4 years of age.

Individuals 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 (each 0.2 mL dose containing 10 mcg modRNA, supplied in multiple dose vials with orange caps and labels with orange borders)
  OR
• a 3-dose primary series initiated 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). Each of Doses 2 and 3 may be with:
  • Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age (supplied in multiple dose vials with maroon caps), or
  • 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 and labels with orange borders).

Dose Preparation

Each vial MUST BE DILUTED before administering the vaccine.

Prior to Dilution

• The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a maroon cap and a label with a maroon border contains a volume of 0.4 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 [2°C to 8°C (35°F to 46°F)] or at room temperature [up to 25°C (77°F)].
  • Refer to thawing instructions in the panels below.

Dilution

Dilute the vial contents using 2.2 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 2.2 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 Maroon Cap and Label with Maroon Border – VIAL VERIFICATION
✓ Maroon plastic cap and label with maroon border.	Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a maroon plastic cap and a label with a maroon border.
Pfizer-BioNTech COVID-19 Vaccine Vial with Maroon Cap and Label with Maroon Border – THAWING PRIOR TO DILUTION
Store 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 2 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.
Gently × 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 Maroon Cap and Label with Maroon Border – DILUTION
Add 2.2 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 2.2 mL of diluent into a transfer syringe (21-gauge or narrower needle). Cleanse the vaccine vial stopper with a single-use antiseptic swab. Add 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial.
Pull back plunger to 2.2 mL to remove air from vial.	Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe.
Gently × 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.
Record 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 Maroon Cap and Label with Maroon Border - WITHRAWAL OF INDIVIDUAL 0.2 mL DOSES
Withdraw 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 maroon caps and labels with maroon 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 participants 6 through 23 months of age following administration of the Pfizer-BioNTech COVID-19 Vaccine included irritability, decreased appetite, tenderness at the injection site, injection site redness, fever, injection site swelling, and lymphadenopathy (see Full EUA Prescribing Information).

Adverse reactions in participants 2 through 4 years of age following administration of the Pfizer-BioNTech COVID-19 Vaccine included pain at the injection site, fatigue, injection site redness, fever, headache, injection site swelling, chills, muscle pain, joint pain, and lymphadenopathy (see Full EUA Prescribing Information).

Adverse Reactions 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 AUTHORIZATION

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 myocarditis,
   • cases of pericarditis,
   • 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 myocarditis, cases of pericarditis, 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.

Website	Fax number	Telephone number
www.pfizersafetyreporting.com	1-866-635-8337	1-800-438-1985

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 website	Telephone number
www.cvdvaccine.com	1-877-829-2619 (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 to prevent 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

Manufactured by
Pfizer Inc., New York, NY 10017

LAB-1516-2.0

Revised: 31 August 2022

END SHORT VERSION FACT SHEET

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

---

1

For vaccination of individuals 5 through 11 years of age and 12 years of age and older, refer to the respective Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine.

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     11.3 Pediatric Use 13 DESCRIPTION 14 CLINICAL PHARMACOLOGY   14.1 Mechanism of Action 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA   18.1 Efficacy of a 2-Dose Primary Series in Participants 16 Years of Age and Older   18.2 Effectiveness of a 3-Dose Primary Series in Participants 6 Months Through 4 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.

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 a maroon cap and a label with a maroon border, which is authorized for use in individuals 6 months through 4 years of age.

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 a maroon cap and a label with a maroon border.

Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Maroon Cap and a Label with a Maroon Border

Age Range	Dilution Information	Doses Per Vial After Dilution	Dose Volume
* The vial labels may state "Age 2y to < 5y" or "Age 6m to < 5y" and carton labels may state "For age 2 years to < 5 years" or "For age 6 months to < 5 years". Vials with either printed age range can be used for individuals 6 months through 4 years of age.
6 months through 4 years*	Dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use	10	0.2 mL

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 maroon caps and labels with maroon borders is 0.2 mL for individuals 6 months through 4 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

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 myocarditis, cases of pericarditis, 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. 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.

In a clinical study (Study 3) in participants 6 through 23 months of age who received Pfizer-BioNTech COVID-19 Vaccine containing 3 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (3 mcg modRNA), adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (Study 3) in participants 2 through 4 years of age who received Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA), adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS

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 myocarditis
• Cases of pericarditis
• 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

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

13 DESCRIPTION

The Pfizer-BioNTech COVID-19 Vaccine in multiple dose vials with maroon caps and labels with maroon borders is supplied as a frozen suspension; each vial must be diluted with 2.2 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 maroon caps and labels with maroon borders contains 3 mcg of modRNA encoding the viral spike (S) glycoprotein of the SARS-CoV-2 Wuhan-Hu-1 strain.

Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with maroon caps and labels with maroon borders also includes the following ingredients: lipids (0.04 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.005 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.01 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.02 mg cholesterol), 3.2 mg sucrose, 0.006 mg tromethamine, and 0.04 mg tromethamine hydrochloride. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 1.52 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

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

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 maroon caps and labels with maroon borders. These multiple dose vials are supplied in a carton containing 10 multiple dose vials (NDC 59267-0078-4). 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.

20 PATIENT COUNSELING INFORMATION

Advise the 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.

Website	Telephone number
www.cvdvaccine.com	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.

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

Manufactured by
Pfizer Inc., New York, NY 10017

LAB-1515-2.0

Revised: 31 August 2022

FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE

FOR 6 MONTHS THROUGH 4 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.

The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a 3-dose primary series to individuals 6 months through 4 years of age.2

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
• 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.

The vaccine is administered as a 3-dose series. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose.

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 5 years of age and older have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. In a clinical trial, approximately 1,200 individuals 6 months through 23 months of age, approximately 1,800 individuals 2 through 4 years of age, and approximately 3,100 individuals 5 through 11 years of age have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. In another clinical trial, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.

The vaccine that is authorized for use in children 6 months through 4 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, particularly during the 2 weeks after your child receives a dose of the vaccine:

• Chest pain
• Shortness of breath or difficulty breathing
• Feelings of having a fast-beating, fluttering, or pounding heart
• Fainting
• Unusual and persistent irritability
• Unusual and persistent poor feeding
• Unusual and persistent fatigue or lack of energy
• Persistent vomiting
• Persistent pain in the abdomen
• Unusual and persistent cool, pale skin

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/tenderness
• 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
• Irritability

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.

Website	Fax number	Telephone number
www.pfizersafetyreporting.com	1-866-635-8337	1-800-438-1985

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?

For children 6 months through 4 years of age, there are no other COVID-19 vaccines available under Emergency Use Authorization and there are no approved COVID-19 vaccines.

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.

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 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 website	Telephone number
www.cvdvaccine.com	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 for 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

Manufactured by
Pfizer Inc., New York, NY 10017

LAB-1517-1.0

Revised: 17 June 2022

	Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems.
GDTI: 0886983000486

---

2

You may receive this Fact Sheet even if your child is 5 years old. Children who will turn from 4 years to 5 years of age between any doses in the primary series, and who received a first dose with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, may also receive this vaccine for doses 2 and/or 3 of the primary series.

PRINCIPAL DISPLAY PANEL - 2.6 mL Vial Label

Pfizer-BioNTech COVID-19 Vaccine

DILUTE PRIOR TO USE
Age 6m - 4y

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 12 hours.

Dilution date and time:

NDC 59267-0078-1

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

Pfizer-BioNTech
COVID-19 Vaccine

NDC 59267-0078-4

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 6 months through 4 years

BIONTECH
Pfizer

Rx only