Dosing & Preparation
COMIRNATY® (COVID-19 Vaccine, mRNA)
2023-2024 Formula
Information Updates
Available Presentations for Eligible Individuals 12 Years of Age and Older
Regardless of presentation, during storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
COMIRNATY Single Dose Vials
COMIRNATY® (COVID-19 Vaccine, mRNA)
2023-2024 Formula
Refrigerated Storage Time: Up to 10 weeks*
ULT Storage Time: 12 months
Dilution: DO NOT DILUTE
Dose: 30 mcg
Dose per vial: Single dose
COMIRNATY Single Dose Plastic Prefilled Syringes
COMIRNATY® (COVID-19 Vaccine, mRNA)
2023-2024 Formula
Refrigerated Storage Time: Up to 10 weeks*
ULT Storage Time: 9 months
Dilution: N/A
Dose: 30 mcg
Dose per syringe: Single dose
COMIRNATY Single Dose Glass Prefilled Syringes
COMIRNATY® (COVID-19 Vaccine, mRNA)
2023-2024 Formula
Refrigerated Storage Time: Up to 6 months*
DO NOT FREEZE
Dilution: N/A
Dose: 30 mcg
Dose per syringe: Single dose
*When stored in a refrigerator, gray cap vials and plastic prefilled syringes should be used within 10 weeks from transfer to refrigerated storage. Glass prefilled syringes should be used within 6 months from date of manufacture, until the expiration date printed on the carton and syringe labels. DO NOT FREEZE. Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials, prefilled syringes, and cartons.
Dose Preparation & Administration1†
Step 1: Verify Vials/Prefilled Syringes
Verify that the single dose vial or prefilled syringe says 2023-2024 Formula.
- Vials are supplied in a carton containing 10 vials.
- Prefilled syringes are supplied in a carton containing 10 syringes.
- Each prefilled syringe contains a single 0.3 mL dose.
- Prefilled syringes are supplied in a carton containing 10 syringes.
- Each prefilled syringe contains a single 0.3 mL dose.
Step 2: Thaw Vials/Prefilled Plastic Syringes (If Frozen)
NOTE: Single Dose Glass Prefilled Syringes are never frozen
If frozen, single dose vials and prefilled syringes may be thawed one of two ways:
In the refrigerator
OR at room temperature.
Do not refreeze thawed vials
Thaw in the refrigerator at 2°C to 8°C (35°F to 46°F)
OR
Thaw at room
temperature up to 25°C (77°F) for 30 minutes
DO NOT REFREEZE THAWED SYRINGES
Do not remove syringe from carton to thaw
Thaw in carton in the refrigerator
at 2°C to 8°C (35°F to 46°F) for 2 hours
OR
Thaw in
carton at room temperature
up to 25°C (77°F) for 60 minutes
DO NOT FREEZE
Do not freeze prefilled glass syringes. If glass prefilled syringes have been frozen, discard
Storage and Expiration
Single Dose Vials and Plastic Single Dose Prefilled Syringes
Verify that product has not expired.
Received ULT and Stored in ULT
- When stored at ULT, gray cap vials should not be used after 12 months from date of manufacture and plastic prefilled syringes should not be used after 9 months from date of manufacture.
Received ULT and Transferred to Refrigerator
- Once received, frozen plastic prefilled syringes and vials may be immediately transferred to the refrigerator at 2°C to 8°C (35°F to 46°F), thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.
Received Refrigerated and Stored in Refrigerator
- Thawed vials and plastic prefilled syringes can be stored in the refrigerator for 10 weeks from time of transfer.
- DO NOT FREEZE.
The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed 12 hours.
If individual frozen plastic prefilled syringes are thawed at room temperature outside of the carton, they can be kept at room temperature and must be used within 4 hours of thawing.
Glass Single Dose Prefilled Syringes
DO NOT FREEZE. If glass prefilled syringe has been frozen, discard.
Verify that product has not expired. Glass prefilled syringes should be used within 6 months from date of manufacture.
Received Refrigerated and Stored in Refrigerator
- Glass prefilled syringes may be stored in a refrigerator at 2°C to 8°C (35°F to 46°F) until the expiration date printed on the carton and syringe labels.
The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed 12 hours.
Step 3: Preparation
DO NOT DILUTE
- Vials must be mixed before use.
- Mix by inverting the vial gently 10 times.
- Do not shake.
- Do not shake.
- Remove tip cap and attach a sterile needle.
- Use immediately.
- If it cannot be used immediately, it must be used within 4 hours.
DO NOT FREEZE
- Do not shake.
- Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile needle.
- If it cannot be used immediately, it must be used within 4 hours.
Step 4: Administration
- Visually inspect for particulate matter and discoloration prior to administration (whenever solution and container permit).
- Vaccine will be a white to off-white suspension.
- DO NOT ADMINISTER if vaccine is discolored or contains particulate matter.
DO NOT DILUTE
- Withdraw a single 0.3 mL dose using sterile needle and syringe.
- Administer the 0.3 mL dose intramuscularly immediately after preparation.
- Discard vial and any excess volume.
Administer the entire volume to deliver a single 0.3 mL dose.
DO NOT FREEZE
Administer the entire volume to deliver a single 0.3 mL dose.
†Refer to product labeling for detailed thawing instructions and information related to product handling.
For eligibility, dosing schedule, and other important information, please see Full Prescribing Information and Patient Information.
Ensuring the Authenticity of
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
- Pfizer is committed to patient safety and ensuring that people have accurate information about the
vaccines, including how they are accessed and administered. We are actively monitoring for fraudulent
offers of illegitimate vaccines to protect patients from products that might be dangerous and lead to
serious and life-threatening harm.
- The vaccines are only administered intramuscularly by a healthcare professional1
- The vaccines are not taken orally and are not available in a capsule or tablet form1
- Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and can be visually verified via this page.
- Ensure the security of the vaccine vials and prefilled syringes by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use. To prevent counterfeits, discard vaccine vials and prefilled syringes in sharps containers and empty vaccine cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through established medical centers—such as doctor’s offices, pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccines can only be administered by licensed healthcare professionals or other individuals who are approved vaccinators. Individual doses are not for sale.2,3
- Ensure the security of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use. To prevent counterfeits, discard vaccine vials in sharps containers and empty vial cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through established medical centers—such as doctor’s offices, pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccines can only be administered by licensed healthcare professionals or other individuals who are approved vaccinators. Individual doses are not for sale.2,3
If you suspect the vaccine you have purchased may be counterfeit, contact us
at
To learn more, visit
https://www.pfizer.com/products/medicine-safety/counterfeiting.
-
COMIRNATY® (COVID-19 Vaccine, mRNA). Full Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc. October 17, 2023.
-
Centers for Disease Control and Prevention. COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations. Version 2.0. October 29, 2020. Accessed October 02, 2023. https://www.cdc.gov/vaccines/imz-managers/downloads/covid-19-vaccination-program-interim_playbook.pdf
-
U.S. Department of Defense. Memorandum: Secure disposal of vaccine vials and packaging recommendations. February 02, 2021.
Eligible healthcare providers can
order COVID-19 vaccines directly
from Pfizer*
Learn about ordering vaccines through Pfizer
Prime online or by calling 1-800-533-4535.
*If preferred, orders may be placed with your facility's
wholesaler. All vaccine presentations may not be available directly through Pfizer.
INFORMATION
INDICATION
IMPORTANT SAFETY INFORMATION
INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (
Do not administer COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.
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 COMIRNATY.
Myocarditis and Pericarditis
Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For COMIRNATY, the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.
The Centers for Disease Control and Prevention (CDC) has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. 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 COMIRNATY.
Limitation of Vaccine Effectiveness
COMIRNATY may not protect all vaccine recipients.
Adverse Reactions
The most commonly reported adverse reactions (≥10%) after a dose of COMIRNATY were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at
Please click for COMIRNATY Full Prescribing Information and Patient Information.
For More Information
Get COVID-19 Vaccine–Related Info Texted Directly to Your Mobile Device
Enroll in the
healthcare professionals.
Get Email Updates From Pfizer
Register to receive the latest updates from Pfizer—right in your inbox.
Sign Up
Our representatives are available 9
COMIRNATY (COVID-19 Vaccine, mRNA) PRESCRIBING INFORMATION: UPDATED 10/17/23
COMIRNATY Single dose Glass Prefilled Syringes 2023-2024 Formula Now Available
- DO NOT FREEZE. COMIRNATY Single Dose Glass Prefilled Syringes are stored in the refrigerator.
- If glass prefilled syringe has been frozen, discard.
- Do not shake.
- Refrigerator-stable for up to 6 months from date of manufacture to the expiration date printed on the carton and on the syringe labels.
- Ready to use. Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile needle.
- See COMIRNATY Full Prescribing Information for Preparation for Administration and Storage Prior to Use.
2023-2024 FORMULA FDA APPROVED: Effective 09/11/23
COMIRNATY® (COVID-19 Vaccine, mRNA) 2023-2024 FORMULA IS FDA APPROVED FOR ACTIVE IMMUNIZATION TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) CAUSED BY SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-CoV-2) IN INDIVIDUALS 12 YEARS OF AGE AND OLDER.
Click to view the Full Prescribing Information and Patient Information.
To prevent vaccine administration errors, prior to preparation and administration:
- Please verify that vial labels or prefilled syringes state COMIRNATY® (COVID-19 Vaccine, mRNA) 2023-2024 Formula.
- Verify the prefilled syringe or vial cap color and label are for the appropriate age group.
Please see the Formulation/Presentation Guide for more details.
Important Reminder:
Previous COVID-19 vaccines, including original monovalent COVID-19
vaccines and bivalent (original and Omicron BA.4/BA.5) mRNA
COVID-19 vaccines are no longer authorized for use in the United
States.
FDA and CDC guidance is to check inventory and dispose of
previous COVID-19 vaccines according to state and local
regulations.
Regardless of storage condition, the vaccine should not be used after
the expiration date printed on the vials, prefilled syringes, and
cartons.
Read the
Important Safety Information
below and check back for further updates.
Close
