Dosing & Storage
Storage & HandlingDownloadable
Resources
Expiry Information
Formulation/Presentation Guide
Updated 12/08/2022
Catalogue of Thermal Shipping Containers
Updated 04/20/2022
Shipping and Handling Guidelines -
Single-Use Thermal Shipping
Container
Updated 01/24/2022
Shipping and Handling Guidelines - Medium Thermal Shipping
Container
Updated 01/24/2022
Returning Real-Time Temperature Monitor and Thermal Shipping Container
Updated 11/19/2021
Checklist for Storage, Handling, and Preparation
Updated 07/20/2022
Authorized Use
Important Safety Information
Important Safety Information
Authorized Use
This EUA Prescribing Information pertains only to
Important Safety Information
Do not administer
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
Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/
Myocarditis and Pericarditis
Myocarditis and pericarditis have been reported following administration of
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
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 Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Limitation of Effectiveness
Pfizer-BioNTech COVID-19, Bivalent Vaccine 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 clinical study (30 mcg modRNA) that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).
In a clinical study (10 mcg modRNA) of participants 5 through 11 years of age, adverse reactions following administration of a single booster dose of Pfizer-BioNTech COVID-19 Vaccine were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).
Post Authorization Experience
Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, 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 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.
Before administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), please click to see
Click here for Recipients and Caregivers Fact Sheet: (Primary Series and Bivalent Booster Dose 5 through 11 years of age)
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