Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine

PFIZER-BIONTECH COVID-19 VACCINE- tozinameran injection, suspension
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- tozinameran and famtozinameran injection, suspension
Pfizer Manufacturing Belgium NV

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)

EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) 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 products, Pfizer-BioNTech COVID-19 Vaccine 1 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 2, for active immunization to prevent COVID-19 in individuals 6 months of age and older.

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for use in individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders.

Primary Series

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent are authorized for use in individuals 6 months through 4 years of age to provide a 3-dose primary series as follows:

Dose 1: Pfizer-BioNTech COVID-19 Vaccine

Dose 2: Pfizer-BioNTech COVID-19 Vaccine

Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Booster Dose

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 4 years of age to provide a single booster dose at least 2 months after completion of primary vaccination with 3 doses of the Pfizer-BioNTech COVID-19 Vaccine 3.

This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in multiple dose vials with maroon caps and labels with maroon borders, which MUST BE DILUTED PRIOR TO USE.

The Pfizer-BioNTech COVID-19 Vaccine 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 in individuals 6 months through 4 years of age.

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19, Bivalent which are supplied in multiple dose vials with maroon caps and labels with maroon borders, should not be used in individuals 5 years of age and older because of the potential for vaccine administration errors, including dosing errors. 4

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 or Pfizer-BioNTech COVID-19 Vaccine, Bivalent. See “MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE AND PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent are suspensions for intramuscular injection.

Primary Series

The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution are administered intramuscularly as a 3-dose (0.2 mL each) primary series as follows:

Dose 1: Pfizer-BioNTech COVID-19 Vaccine

Dose 2: Pfizer-BioNTech COVID-19 Vaccine

Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Dose 1 and Dose 2 (Pfizer-BioNTech COVID-19 Vaccine) are administered 3 weeks apart. Dose 3 (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) is administered at least 8 weeks after Dose 2.

Individuals who will turn from 4 years to 5 years of age between any doses in the primary series 5 may receive either:

•

a 3-dose primary series comprised of Pfizer-BioNTech COVID-19 Vaccine (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Doses 1 and 2 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Dose 3, or

•

a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use for individuals 5 through 11 years of age (supplied in multiple dose vials with orange caps and labels with orange borders).

Booster Dose

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 4 years of age to provide a single booster dose (0.2 mL) at least 2 months after completion of primary vaccination with 3 doses of the Pfizer-BioNTech COVID-19 Vaccine.

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 and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent which are supplied in multiple dose vials with maroon caps and labels with maroon borders and MUST BE DILUTED before use.

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Multiple Dose Vials with Maroon Caps and a Labels with Maroon Borders

Age Range	Dilution Information	Doses Per Vial After Dilution	Dose Volume
* The Pfizer-BioNTech COVID-19 Vaccine 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 18 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 18 months from the date of manufacture printed on the vial and cartons. Examples of expiry dates based on 18 months from the date of the manufacture for the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent are shown below.

Printed Manufacturing Date		18-Month Expiry Date
01/2022		30-Jun-2023
02/2022		31-Jul-2023
03/2022		31-Aug-2023
04/2022		30-Sep-2023
05/2022		31-Oct-2023
06/2022		30-Nov-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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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.

Pfizer-BioNTech COVID-19 Vaccine vial labels and cartons may state that vials 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 and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age is supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution is administered intramuscularly as a 3-dose (0.2 mL each) primary series as follows:

Dose 1: Pfizer-BioNTech COVID-19 Vaccine

Dose 2: Pfizer-BioNTech COVID-19 Vaccine

Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Dose 1 and Dose 2 (Pfizer-BioNTech COVID-19 Vaccine) are administered 3 weeks apart. Dose 3 (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) is administered at least 8 weeks after Dose 2.

Individuals who will turn from 4 years to 5 years of age between any doses in the primary series may receive either:

•

a 3-dose primary series comprised of Pfizer-BioNTech COVID-19 Vaccine (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Doses 1 and 2 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Dose 3, or

•

a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use for individuals 5 through 11 years of age (supplied in multiple dose vials with orange caps and labels with orange borders).

Booster Dose

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 4 years of age to provide a single booster dose (0.2 mL) at least 2 months after completion of primary vaccination with 3 doses of the Pfizer-BioNTech COVID-19 Vaccine.

Dose Preparation

Each vial MUST BE DILUTED before administering the vaccine.

Prior to Dilution

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The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials with maroon caps and labels with maroon borders contain a volume of 0.4 mL, and are supplied as frozen suspensions that do not contain preservative.

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Each vial must be thawed before dilution.

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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)].

o

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 or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vials with Maroon Caps and Labels with Maroon Borders – VIAL VERIFICATION
✓ Maroon plastic cap and label with maroon border. ✓ Maroon plastic cap and label with maroon border.	• For Dose 1 and Dose 2 verify that the vial of Pfizer-BioNTech COVID-19 Vaccine: o has a maroon plastic cap and a label with a maroon border, o states Pfizer-BioNTech COVID-19 Vaccine, and o states “Age 2y to < 5y” or “Age 6m to < 5y”. • For Dose 3 verify that the vial of Pfizer-BioNTech COVID-19 Vaccine, Bivalent: o has a maroon cap and a label with a maroon border, o states Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), and o states “Age 6m to < 5y”.
Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vials with Maroon Caps and Labels with Maroon Borders – THAW PRIOR TO DILUTION
Store in the refrigerator for up to 10 weeks prior to use.	• Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent before use either by: o 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. o 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.
(click image for full-size original) 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vials with Maroon Caps and Labels with Maroon Borders – DILUTION
(click image for full-size original) 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.
(click image for full-size original) 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.
(click image for full-size original) Gently × 10	• Gently invert the vial containing the Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vials with Maroon Caps and Labels with Maroon Borders — WITHDRAWAL OF INDIVIDUAL 0.2 mL DOSES
(click image for full-size original) 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 or Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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,

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verify the final dosing volume of 0.2 mL.

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confirm there are no particulates and that no discoloration is observed.

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do not administer if vaccine is discolored or contains particulate matter.

Administer the Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent intramuscularly.

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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:

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Each dose must contain 0.2 mL of vaccine.

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If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and content.

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Do not pool excess vaccine from multiple vials.

Contraindications

Do not administer Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second dose of a 2-dose primary series or the first booster dose (third dose), with most booster doses likely administered at least 5 months after completing primary vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, 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 or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Limitation of Effectiveness

The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.

Adverse Reactions

Adverse Reactions in Clinical Trials

The safety of Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months through 4 years of age is based on:

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safety data from a clinical study which evaluated a 3-dose primary series of Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months through 4 years of age,

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safety data from clinical studies which evaluated a 2-dose primary series of Pfizer-BioNTech COVID-19 Vaccine in individuals 5 years of age and older, and

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postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine.

The safety of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months through 4 years of age is based on:

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safety data from clinical studies which evaluated a booster dose of Pfizer-BioNTech Vaccine, Bivalent (Original and Omicron BA.4/BA.5) in individuals 6 months of age and older,

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safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1) in individuals greater than 55 years of age,

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The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

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safety data from clinical trials which evaluated primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older and

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safety data from clinical trials which evaluated booster vaccination in individuals 5 years of age and older with the Pfizer-BioNTech COVID-19 Vaccine (previously, but no longer, authorized), and

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postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Adverse reactions in participants 6 through 23 months of age following administration of the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent included irritability, drowsiness, decreased appetite, tenderness at the injection site, injection site redness, fever, injection site swelling, fatigue, 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 and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent included pain at the injection site, fatigue, diarrhea, injection site redness, fever, headache, injection site swelling, chills, vomiting, muscle pain, joint pain, and lymphadenopathy (see Full EUA Prescribing Information).

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

Adverse reactions in participants 12 years of age and older following administration the Pfizer-BioNTech COVID-19 Vaccine, Bivalent included injection site pain, fatigue, headache, muscle pain, chills, joint pain, diarrhea, fever, injection site swelling, injection site redness, vomiting, and lymphadenopathy (see Full EUA Prescribing Information).

Adverse reactions in participants greater than 55 years of age following administration of the bivalent vaccine (Original and Omicron BA.1) included pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, injection site redness, injection site swelling, fever, lymphadenopathy, nausea, and malaise.

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), syncope, and dizziness have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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

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

Use with Other Vaccines

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

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the caregiver 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 or Pfizer-BioNTech COVID-19 Vaccine, Bivalent, including:

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FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which are not FDA-approved vaccines.

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There is an option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and the extent to which such risks and benefits are unknown.

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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 or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the caregiver with the date when the recipient needs to return for the next dose of the primary series.

Provide the v-safe information sheet to caregivers and encourage caregivers to participate in v-safe on behalf of the recipient. 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 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 AND PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, the following items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent are 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 the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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):

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vaccine administration errors whether or not associated with an adverse event,

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serious adverse events* (irrespective of attribution to vaccination),

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cases of myocarditis,

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cases of pericarditis,

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cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and

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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 or Pfizer-BioNTech COVID-19 Vaccine, Bivalent to recipients.

* Serious adverse events are defined as:

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Death;

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A life-threatening adverse event;

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Inpatient hospitalization or prolongation of existing hospitalization;

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A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;

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A congenital anomaly/birth defect;

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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 or Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 byPfizer Inc., New York, NY 10001

LAB-1516-5.0

Revised: 14 March 2023

END SHORT VERSION FACT SHEET

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