Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 2 of 8)


1
Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.
2
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine must adhere to the same reporting requirements.
FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)
FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*
1
AUTHORIZED USE
2
DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Administration Information
2.3 Vaccination Schedule
3
DOSAGE FORMS AND STRENGTHS
4
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
5.2 Myocarditis and Pericarditis
5.3 Syncope
5.4 Altered Immunocompetence
5.5 Limitation of Effectiveness
6
OVERALL SAFETY SUMMARY
6.1 Clinical Trials Experience
6.2 Post Authorization Experience
8
REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS
10
DRUG INTERACTIONS
11
USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
11.2 Lactation
11.3 Pediatric Use
11.4 Geriatric Use
13
DESCRIPTION
14
CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
18
CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
18.1 Efficacy of Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Participants 16 Years of Age and Older
18.2 Efficacy of Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Adolescents 12 Through 15 Years of Age
18.3 Immunogenicity of Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Adolescents 12 Through 15 Years of Age
18.4 Immunogenicity of the Bivalent Vaccine (Original and Omicron BA.1) Administered as a Second Booster Dose
18.5 Immunogenicity of a First Booster Dose With a Pfizer-BioNTech COVID-19 Vaccine Primary Series in Participants 18 Through 55 Years of Age
18.6 Immunogenicity of a First Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine
19
HOW SUPPLIED/STORAGE AND HANDLING
20
PATIENT COUNSELING INFORMATION
21
CONTACT INFORMATION

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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 12 years of age and older.

This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

2 DOSAGE AND ADMINISTRATION

The storage, preparation, and administration information in this Prescribing Information 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.

2.1 Preparation for Administration

  • 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)] [see How Supplied/Storage and Handling (19)].
  • 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 [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.
    • Allowing vial(s) to sit at room temperature [up to 25°C (77°F)] for 30 minutes.
  • Thawed vials can be stored in the refrigerator [2°C to 8°C (35°F to 46°F)] for up to 10 weeks prior to use.
  • Thawed vials may be stored at room temperature [up to 25°C (77°F)] 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.

2.2 Administration Information

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.

2.3 Vaccination 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.

3 DOSAGE FORMS AND STRENGTHS

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

Each dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent is 0.3 mL [see Dosage and Administration (2.1)].

4 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 Description (13)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine, 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).

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