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LOW DEAD-VOLUME (LDV)
SYRINGES AND/OR NEEDLES GUIDE
* 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.
1 of 3Please see Indication, Authorized Use, and Important Safety Information on page 3. 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).Pfizer-BioNTech COVID-19 Vaccine, also known as
COMIRNATY® (COVID-19 Vaccine, mRNA)*
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.
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 ).
GLOBAL: Drives to http://labeling.pfizer.com/ShowLabeling.aspx?id=15623
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=14471&format=pdf
GLOBAL: Drives to http://labeling.pfizer.com/
ShowLabeling.aspx?id=14472&format=pdf
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2 of 3Use of low dead-volume (LDV) syringes and/or needles may maximize the potential number of vaccine doses and
minimize vaccine wastage2
Low dead-volume (also called low dead-space) is the amount of fluid remaining within the syringe and needle after an injection is completed
3After dilution, vials of the vaccine contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial.
1
Compatible LDV syringe and/or needle pairings may successfully withdraw 6 doses of the vaccine, but not all combinations have been assessed or have a low dead volume that is small enough to allow extraction of a sixth dose.
4i
The Centers for Disease Control and Prevention (CDC) is partnering with McKesson to provide ancillary kits containing needles and syringes for use with all COVID-19 vaccines. Please reach out to your state, local, or tribal health department and/or the CDC for more information. Pfizer makes no guarantee of the type or quality of the needles and syringes within the ancillary kits or the capability to withdraw 6 doses. For further information, please contact the manufacturer directly. Characteristics of LDV syringes and needles4
LDV SYRINGES have plungers
molded to the luer cone, allowing
fluid to be cleared from the syringe tip during injectionWithdrawal of 6 doses is unlikely with standard detachable needles with standard syringedead-volume
needle and syringedead-volume modified syringedead-volume detachableneedledead-volume fixed “all-in-one” needle and syringe
LDV NEEDLES have an extension
of the needle that fits through the opening of some standard syringes, allowing for a reduction
in dead space FIXED-NEEDLE SYRINGES have low dead volumes and will, in
most cases, achieve 6 doses of
the vaccine
HIGH REDUCED LOW LOW
Please see Indication, Authorized Use, and Important Safety Information on page 3. 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) .LOW DEAD-VOLUME (LDV) SYRINGES AND/OR NEEDLES GUIDE
Find additional resources about the vaccine at www.cvdvaccine-us.com
Drives to https://
www.cvdvaccine-us.com/
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3 of 3PP-CVV-USA-0389
© 2021 Pfizer Inc. All rights reserved. September 2021References: 1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; 2021. 2. Jarrahian C, Rein-Weston A, Saxon G, et al. Vial usage, device dead
space, vaccine wastage, and dose accuracy of intradermal delivery devices for inactivated po iovirus vaccine (IPV). Vaccine. 2017;35:1789-1796. 3. Kesten JM, Ayres R, Neale J, et al.
Acceptability of low dead space syringes and imp ications for their introduction: a qua itative study in the West of England. Int J Drug Policy. 2017;39:99-108. 4. Data on File. Pfizer Inc.
New York, NY.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech
proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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).
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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