Document text
for storage, handling, and preparation of the
Pfizer-BioNTech COVID-19 Vaccine, also known as
COMIRNATY® (COVID-19 Vaccine, mRNA)*CHECKLIST
1 of 4Please see Indication, Authorized Use, and Important Safety Information on page 4. Before administration of the
vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers
(12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).Important Safety Information
Known history of a severe allergic reaction (eg, anaphylaxis) to any component of COMIRNATY® is a contraindication.
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an
acute anaphylactic reaction occurs following administration of the vaccine.
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/covid-19/clinical-considerations/managing-anaphylaxis.html ).* The licensed COMIRNATY® vaccine has the same formulation as the authorized vaccine Pfizer-BioNTech COVID-19 Vaccine,
and they can be used interchangeably without presenting any safety or effectiveness concerns. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness.
The emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
GLOBAL: Drives to https://www.cdc.gov/vaccines/covid-19/clinical-considerations/
managing-anaphylaxis.html
GLOBAL: Drives to http://
labeling.pfizer.com/
ShowLabeling.aspx?id=15623
GLOBAL: Drives to http://
labeling.pfizer.com/
ShowLabeling.aspx?
id=14471&format=pdf
GLOBAL: Drives to http://
labeling.pfizer.com/
ShowLabeling.aspx?
id=14472&format=pdf
FDA-CBER-2021-5683-0951614
2 of 4Please see Indication, Authorized Use, and Important Safety Information on page 4. Before administration of the
vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers
(12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age) .Storage and Handling of the Vaccine and Thermal Shipping Container
Before receiving the thermal shipping container, you must have :
A well-ventilated room set up to safely handle the thermal shipping container and dry ice
An appropriate area for discarding dry ice so it can
sublimate from a solid to a gas
A method for tracking dry ice replenishment dates to
ensure protocol is being followed (if using the thermal shipping container as temporary storage)Proper security so only authorized personnel can access the thermal shipping container contents
Access to an occupational health department that can
be consulted to ensure appropriate safeguardsMaterials checklist for storage and handling:
For 195-pack cartons only, if using the thermal
shipping container as temporary storage, you will
also need:
Dry ice supply (ice pellets 10-16 mm, for re-icing)
Dry ice scoop Temperature-monitoring devicePacking tape or equivalentSafety goggles or safety glasses with side shields
Waterproof insulated gloves Box cutter or tool to open boxHand truck or dolly to move the thermal shipping
container, which can weigh up to ~36 kg (~80 lb)
Ultra-low-temperature freezer or refrigerator; for
alternate, temporary storage options available, please visit https://www.cvdvaccine-us.comReview the following instructional materials on www.cvdvaccine-us.com:
EUA Fact Sheet for Vaccination Providers (12 years of
age and older)
Full Prescribing Information (16 years of age and older)EUA Fact Sheet for Recipients and Caregivers
(12 years of age and older)
How to Administer GuideLow Dead-Volume Syringes and/or Needles Information
Sheet
Dry Ice Replenishment Instructions Thermal Shipping Container Return InstructionsShipping & Handling GuidelinesVaccine Dosing GuideMULTIPLE DOSE VIAL
Reminder: The vaccine comes in a multiple dose vial that contains 6 doses after dilution.
Drives to http://
www.cvdvaccine-us.com
FDA-CBER-2021-5683-0951615
3 of 4Please see Indication, Authorized Use, and Important Safety Information on page 4. Before administration of the
vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers
(12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age) .Thawing, Dilution, and Preparation
Materials checklist for vaccine preparation:
Secondary container, such as a small tray, to transport vials removed from original vial carton
Refrigerator (for thawing and to maintain thawed vaccine vials for up to 1 month
at a temperature of 2°C to 8°C [35°F to 46°F])
3-mL or 5-mL syringe (for dilution)21-gauge or narrower needle (for dilution)Low dead-volume syringe and/or needle (for administration) appropriate for intramuscular injectionPersonal protective equipment (including gloves that allow manual dexterity)Vials of 0.9% Sodium Chloride Injection, USP (for one-time use)Vaccine vialsAntiseptic swabsSharps container for disposalMULTIPLE DOSE VIAL
Reminder: The vaccine comes in a multiple dose vial that contains 6 doses after dilution.
Current as of September 22, 2021. For the most up-to-date version,
visit www.cvdvaccine-us.com .
Drives to http://
www.cvdvaccine-us.com
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4 of 4
PP-CVV-USA-0387
© 2021 Pfizer Inc. All rights reserved. September 2021The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech
proprietary mRNA technology, was developed by both BioNTech and Pfizer.
4 of 4Important Safety Information
Known history of a severe allergic reaction (eg,
anaphylaxis) to any component of COMIRNATY® is a contraindication.
Appropriate medical treatment used to manage
immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
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/covid-19/clinical-considerations/managing-anaphylaxis.html).
Postmarketing data demonstrate increased risks of
myocarditis and pericarditis, particularly within 7 days following the second dose.
Syncope (fainting) may occur in association with
administration of injectable vaccines, including this vaccine. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including individuals
receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
The vaccine may not protect all vaccine recipients.In clinical studies of participants 16 through 55
years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).
In clinical studies of participants 56 years of age and
older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
In a clinical study, adverse reactions in adolescents
12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).Indication
COMIRNATY® is a vaccine indicated for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in individuals 16 years of age
and older.
Authorized Use
COMIRNATY® (COVID-19 Vaccine, mRNA) is also authorized for emergency use in individuals 12 through 15 years and to provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.
The Pfizer-BioNTech COVID-19 Vaccine has received
Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.
The FDA-approved COMIRNATY® (COVID-19 Vaccine,
mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.
The emergency use of the product has not been
approved or licensed by FDA, but has been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Before administration of the vaccine, please see full
Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).
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