Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- tozinameran and bnt162b2 omicron (ba.4/ba.5) injection, suspension
Pfizer Manufacturing Belgium NV

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)

EMERGENCY USE AUTHORIZATION (EUA)

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) BOOSTER DOSE FOR 12 YEARS OF AGE AND OLDER DO NOT DILUTE

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, Bivalent (Original and Omicron BA.4/BA.5) for active immunization to prevent COVID-19 in individuals 12 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent. It is supplied in single dose and multiple dose vials with gray caps and labels with gray borders.

DO NOT DILUTE PRIOR TO USE.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either:

  • completion of primary vaccination with any authorized or approved monovalent 1 COVID-19 vaccine, or
  • receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in a single dose and multiple dose vial with a gray cap and a label with a gray border, which MUST NOT BE DILUTED PRIOR TO USE.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which is supplied in a single dose and multiple dose vial with a gray cap and a label with a gray border, should not be used in individuals 5 through 11 years of age. 2

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

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

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, 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, Bivalent supplied in:

  • single dose vials with gray caps and labels with gray borders, and
  • multiple dose vials with gray caps and labels with gray borders.

DO NOT DILUTE PRIOR TO USE.

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, Bivalent 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 single dose vials may take up to 2 hours to thaw at this temperature. A carton of 10 multiple dose vials may take up to 6 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, Bivalent 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.

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, Bivalent may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, the multiple dose vial should be held between 2°C to 25°C (35°F to 77°F). Multiple dose vials should be discarded 12 hours after first puncture.

Transportation of Vials

If local redistribution is needed, 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

A single booster dose (0.3 mL) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Dose Preparation

  • Pfizer-BioNTech COVID-19 Vaccine, Bivalent vials contain a frozen suspension without preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use.
  • 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 and preparation instructions in the panels below.
Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial with Gray Cap and Label with Gray Border – VIAL VERIFICATION
FigureGray cap and label with gray border.
  • Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine, Bivalent:
    • has a gray cap and a label with a gray border
    • states Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).
THAWING PRIOR TO USE
FigureStore in the refrigerator for up to 10 weeks prior to use.
  • Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent before use either by:
    • Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)].
      • A carton of 10 single dose vials may take up to 2 hours to thaw.
      • A carton of 10 multiple dose vials may take up to 6 hours to thaw.
    • Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes.
  • Thawed vials can be stored in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 10 weeks prior to use.
  • Thawed vials may be stored at room temperature [up to 25ºC (77ºF)] for up to 12 hours prior to use.
FigureGently × 10
  • Before use, mix by inverting vaccine vial gently 10 times.
  • Do not shake.
  • Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles.
  • After mixing, the vaccine should appear as a white to off-white suspension with no visible particles.
  • Do not use if liquid is discolored or if particles are observed after mixing.
PREPARATION OF INDIVIDUAL 0.3 mL DOSES
Figure
(click image for full-size original)
Withdraw 0.3 mL dose of vaccine.
Single Dose Vial
  • Withdraw a single 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
  • Administer immediately.
  • Discard vial and any excess volume.
Multiple Dose Vial
  • Multiple dose vials contain 6 doses of 0.3 mL each.
  • Withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent preferentially using low dead-volume syringes and/or needles. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial.
  • Administer immediately.
  • If the amount of vaccine remaining in a multiple dose vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Multiple Dose Vial – Record Date and Time of First Puncture
FigureRecord the date and time of first puncture. Use within 12 hours after first puncture.
  • Record the date and time of first vial puncture on the Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vial label.
  • Store between 2°C to 25°C (35°F to 77°F).
  • Discard any unused vaccine 12 hours after first puncture.

Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine will be a white to off-white suspension. Do not administer if vaccine is discolored or contains particulate matter.

After withdrawing a single 0.3 mL dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, administer immediately.

Contraindications

Do not administer 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 or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (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, Bivalent.

Monitor 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 primary series dose or first booster 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 higher among adolescent males and adult males under 40 years of age than among females and older males, and 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, Bivalent.

Limitation of Effectiveness

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

Adverse Reactions

The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent is based on:

  • 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),
  • safety data from clinical trials which evaluated primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, and
  • post marketing safety data with Pfizer-BioNTech COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process. The bivalent vaccine (Original and Omicron BA.1) contained 15 mcg of nucleoside-modified messenger RNA (modRNA) encoding the S-glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineage BA.1, for a total of 30 mcg modRNA per dose. This is the same total quantity of modRNA per dose as a dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent and as a dose of Pfizer-BioNTech COVID-19 Vaccine authorized for primary vaccination in individuals 12 years of age and older (and previously, but no longer, authorized for booster vaccination in individuals 12 years of age and older).

Adverse Reactions in Clinical Trials

Adverse reactions following administration of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine or the bivalent vaccine (Original and Omicron BA.1) that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, injection site redness, lymphadenopathy, nausea, malaise, pain in extremity, rash, and decreased appetite (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 post-authorization use of the 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, Bivalent 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 “Vaccine Information Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent including:

  • FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent which is not an FDA-approved vaccine.
  • The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
  • The significant known and potential risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, 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, Bivalent to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver.

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 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, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION 3

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, Bivalent the following items are required. Use of unapproved 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, Bivalent is authorized for use in individuals 12 years of age and older.
  2. The vaccination provider must communicate to the individual receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent or their caregiver, information consistent with the “Vaccine Information Fact Sheet for Recipients and Caregivers” prior to the individual receiving Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
  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, Bivalent 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, Bivalent 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, Bivalent 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 for use as a booster dose, including bivalent vaccines that contain or encode the spike protein of the Omicron variant of SARS-CoV-2.

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, 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, 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, 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

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Manufactured by Pfizer Inc., New York, NY 10017

LAB-1537-2.0

Revised: 12 October 2022

END SHORT VERSION FACT SHEET

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