Pfizer says COVID bivalent booster vaccine performs well against subvarian
Channel: Diagnosis_Health
Date: 20/12/2022

Nov 4, 2022
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
COVID-19 vaccine, or
 receipt of the most recent booster dose with any authorized or
approved monovalent1 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 6 months through 11 years of age.2
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 Different presentations of Pfizer-BioNTech COVID-19 Vaccine, Bivalent are available.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent, supplied in multiple dose vials with maroon caps and
labels with maroon borders, is available for use as a third dose of the primary series in individuals
6 months through 4 years of age. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, supplied in multiple
dose vials with orange caps and labels with orange borders, is available for use as a single booster
dose in individuals 5 through 11 years of age.
Revised: 8 December 22 1
































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.