Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 5 of 14)

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-authorization use of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Cardiac Disorders: myocarditis, pericarditis

Gastrointestinal Disorders: diarrhea, vomiting

Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)

Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)

Nervous System Disorders: syncope, dizziness

6.3 Required Reporting for Adverse Events and Vaccine Administration Errors

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for the MANDATORY reporting of the listed events following administration of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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

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Cases of COVID-19 that results in hospitalization or death

*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 one of the outcomes listed above.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods:

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Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or

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If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report, you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to info@vaers.org.

IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include:

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Patient demographics (e.g., patient name, date of birth)

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Pertinent medical history

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Pertinent details regarding admission and course of illness

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Concomitant medications

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Timing of adverse event(s) in relationship to administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent

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Pertinent laboratory and virology information

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Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

1.

In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine, Bivalent and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within one month prior.

2.

In Box 18, description of the event:

a.

Write “Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA” as the first line

b.

Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above.

3.

Contact information:

c.

In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.

d.

In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.

e.

In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).

Other Reporting Instructions

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

7 DRUG INTERACTIONS

There are no data to assess the concomitant administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during pregnancy.

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.

8.2 Lactation

Risk Summary

Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent on the breastfed infant or on milk production/excretion.

8.4 Pediatric Use

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 17 years of age. This authorization is based on safety and effectiveness data with Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and the bivalent vaccine (Original and Omicron BA.1).

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not authorized for use in individuals younger than 6 months of age.

8.5 Geriatric Use

Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older who received the primary series and their data contributes to the overall assessment of safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent [see Adverse Reactions (6.1), Clinical Studies (14)]. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older.

A clinical study with the bivalent vaccine (Original and Omicron BA.1) included 197 individuals 65 years of age and older and their data contribute to the overall assessment of safety and effectiveness of Pfizer-BioNTech COVID-19 Vaccine, Bivalent [see Adverse Reactions (6.1), Clinical Studies (14)].

8.6 Use in Immunocompromised Individuals

From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med), safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status.

11 DESCRIPTION

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent does not contain preservative. The vial stoppers are not made with natural rubber latex.

Multiple Dose Vials with Maroon Caps and Labels with Maroon Borders

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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, Bivalent supplied in multiple dose vials with maroon caps and labels with maroon borders is formulated to contain 1.5 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 1.5 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The S-glycoproteins of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 are identical. Each dose contains 3 mcg modRNA.

Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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.

Multiple Dose Vials with Orange Caps and Labels with Orange Borders

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent in multiple dose vials with orange caps and labels with orange borders is supplied as a frozen suspension; each vial must be diluted with 1.3 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, Bivalent supplied in multiple dose vials with orange caps and labels with orange borders is formulated to contain 5 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 5 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The S-proteins of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 are identical. Each dose contains 10 mcg modRNA.

Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in multiple dose vials with orange caps and labels with orange borders also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine hydrochloride. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium chloride per dose.

Multiple Dose Vials and Single Dose Vials with Gray Caps and Labels with Gray Borders

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent in multiple dose vials and single dose vials with gray caps and labels with gray borders is supplied as a sterile, frozen suspension. This presentation does not need to be diluted.

Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in multiple dose vials and single dose vials with gray caps and labels with gray borders is formulated to contain 15 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (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 lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The S-proteins of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 are identical. Each dose contains 30 mcg modRNA.

Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in multiple dose and single dose vials with gray caps and labels with gray borders also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose.