FDA grants full approval to Pfizer COVID 19 vaccine
Channel: Diagnosis_Health
Date: 2022-12-25

Aug 23, 2021
Pfizer’s COVID-19 vaccine is the first to transition from emergency authorization status to full FDA approval.
IMPORTANT PRESCRIBING INFORMATION
Subject: Pfizer BioNTech COVID-19 Vaccine, Bivalent –
New Vial Presentation Available to Provide Booster Doses for Ages 12 years and older
Dear Healthcare Provider,
On August 31, 2022, the US Food and Drug Administration authorized emergency use of the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter
referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent, 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 monovalent1
COVID-19 vaccine, or
 receipt of the most recent booster dose with any authorized or approved monovalent
COVID-19 vaccine.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent contains an Omicron component to help prevent
COVID-19 caused by the Omicron variant of SARS-CoV-2.
This letter is to alert you that COMIRNATY® (COVID-19 Vaccine, mRNA), one formulation of
the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, and the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent, are all supplied in multiple dose vials with gray
caps and labels with gray borders.
It is important to carefully read the labels to differentiate between the vaccines:
COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19
Vaccine are for use in individuals 12 years of age and older to provide a primary series.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals
12 years of age and older to provide a single booster dose.
The labels for the multiple dose vials of each vaccine are shown below.
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.












Storage and handling requirements for these vaccines are identical.
Vaccination providers must report certain information associated with the administration of the
vaccine to VAERS in accordance with the authorized Fact Sheet.
Should you have any questions about the use of the Pfizer-BioNTech COVID-19 Vaccine,
Bivalent, you can either contact Pfizer-BioNTech at 1(877) 829 2619
or visit www.cvdvaccine-us.com for additional resources.
This letter is not intended as a complete description of the benefits and risks related to the use of
the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Please refer to the authorized PfizerBioNTech COVID-19 Vaccine, Bivalent Fact Sheet.

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