Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 2 of 14)

1 EMERGENCY USE AUTHORIZATION

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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.

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

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not licensed for any use.

Justification for Emergency Use of Vaccines During the COVID-19 Pandemic

There is currently an outbreak of COVID-19 caused by SARS-CoV-2. The Secretary of the Department of Health and Human Services (HHS) has:

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Determined that there is a public health emergency, or a significant potential for a public health emergency, related to COVID-19.1

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Declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.2

An EUA is an FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that use of EUA authority is justified, based on a determination that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:

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The biological agent(s) can cause a serious or life-threatening disease or condition;

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Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that:

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The product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition;

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The known and potential benefits of the product — when used to diagnose, prevent, or treat such disease or condition — outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s); and

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There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.

Information Regarding Available Alternative Vaccines for the Prevention of COVID-19

There may be clinical trials or availability under EUA of other COVID-19 vaccines, including bivalent vaccines that contain or encode the spike protein of the Omicron variant of SARS-CoV-2. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved monovalent COVID-19 vaccines.

For information on clinical studies of Pfizer-BioNTech COVID-19 Vaccine, Bivalent and other vaccines for the prevention of COVID-19, see www.clinicaltrials.gov.

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1

See U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020; https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency. See also U.S. Department of Health and Human Services, Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b). March 15, 2023 (“Amended Determination”); https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration. See U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020; https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency. See also U.S. Department of Health and Human Services, Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b). March 15, 2023 (“Amended Determination”); https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration.

2

See U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020); https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration. See also Amended Determination (“The declarations issued pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of certain in vitro diagnostics, personal respiratory protective devices, other medical devices and drugs and biological products, as set forth in those declarations, and that are based on the February 4, 2020 determination, remain in effect until those declarations are terminated in accordance with section 564 of the FD&C Act.”).

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

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Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials and single dose vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.

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There are 4 presentations of Pfizer-BioNTech COVID-19 Vaccine, Bivalent [see Dosage and Administration (2.3)]:

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Multiple dose vials with maroon caps and labels with maroon borders. This presentation is authorized to provide doses for individuals 6 months through 4 years of age. Must be diluted.

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Multiple dose vials with orange caps and labels with orange borders. This presentation is authorized to provide doses for individuals 5 through 11 years of age. Must be diluted.

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Single dose vials with gray caps and labels with gray borders. This presentation is authorized to provide doses for individuals 12 years of age and older. Do not dilute

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Multiple dose vials with gray caps and labels with gray borders. This presentation is authorized to provide doses for individuals 12 years of age and older. Do not dilute

Thawing Instructions

Thaw each vial before use following the instructions below:

Pfizer-BioNTech COVID-19 Vaccine, Bivalent Presentation	Thawing in Refrigerator
Multiple dose vials with maroon caps and labels with maroon borders	Thaw between 2°C to 8°C (35°F to 46°F) • A carton of 10 vials may take up to 2 hours to thaw.
Multiple dose vials with orange caps and labels with orange borders	Thaw between 2°C to 8°C (35°F to 46°F) • A carton of 10 vials may take up to 4 hours to thaw.
Single dose vials and multiple dose vials with gray caps and labels with gray borders	Thaw between 2°C to 8°C (35°F to 46°F). • 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.

Alternatively, thaw vials at room temperature [up to 25°C (77°F)] for 30 minutes.

Storage of Thawed Vials:

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Thawed vials may be stored at room temperature [up to 25°C (77°F)] for up to 12 hours prior to use.

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Thawed vials can be stored in the refrigerator between 2°C to 8°C (35°F to 46°F) for up to 10 weeks prior to use.

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Do not refreeze.

Preparation Instructions for Multiple Dose Vials with Maroon Caps or Orange Caps that MUST BE DILUTED BEFORE USE:

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Before dilution, invert vaccine vial gently 10 times. Do not shake.

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Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain opaque amorphous particles.

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Do not use if liquid is discolored or if other particles are observed.

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Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent.

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Add the appropriate amount of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial as follows:

Pfizer-BioNTech COVID-19 Vaccine, Bivalent Multiple Dose Vaccine Vial Cap and Label Color	Amount of Sterile 0.9% Sodium Chloride Injection to Use as Diluent
Maroon caps and labels with maroon borders	2.2 mL
Orange caps and labels with orange borders	1.3 mL

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Before removing the needle from the vial, equalize vial pressure by withdrawing air into the empty diluent syringe.

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Gently invert the vial containing the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 10 times to mix.

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Do not shake.

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Inspect the vaccine in the vial.

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The vaccine will be a white to off-white suspension. Do not use if vaccine is discolored or contains particulate matter.

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Record the date and time of dilution on the vial label.

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After dilution, multiple dose vials contain 10 doses of 0.2 mL each.

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Withdraw 0.2 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 10 doses from a single vial.

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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.

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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 any excess volume. Do not pool excess vaccine from multiple vials.

Preparation Instructions for Single Dose Vials and Multiple Dose Vials with Gray Caps and Labels with Gray Borders that MUST NOT BE DILUTED

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Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles.

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Before use, mix by inverting vaccine vial gently 10 times.

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Do not shake.

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After mixing, the vaccine should appear as a white to off-white suspension with no visible particles.

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Do not use if liquid is discolored or if particles are observed after mixing.

Single Dose Vials with Gray Caps and Labels with Gray Borders

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Withdraw a single 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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Administer immediately.

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Discard vial and any excess volume.

Multiple Dose Vials with Gray Caps and Labels with Gray Borders

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Multiple dose vials contain 6 doses of 0.3 mL each.

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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.

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Record the date and time of first vial puncture on the vial label.

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Store between 2°C to 25°C (35°F to 77°F).

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Discard any unused vaccine 12 hours after first puncture.

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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. Do not pool excess vaccine from multiple vials.