Questions and Answers About Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for Ages 12 Years and Older
For information about the monovalent Pfizer-BioNTech COVID-19 Vaccine,
click here.
Approval and
Authorization
Status
Access to Vaccine Supply
Diluent
Dosing and Administration
Storage and Handling
Thermal Shipping Container
Ensuring Authenticity
Administrative Information
Approval and Authorization Status
- 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 monovalent*
COVID-19 vaccine
*Monovalent refers to any authorized or approved
Please see Pfizer-BioNTech
*Pfizer-BioNTech
No. The monovalent
*Monovalent refers to any authorized or approved
Because both the monovalent* and bivalent presentations of
The
The monovalent*
Be sure to verify the vial label prior to dose preparation.
Please see
Please see the Formulation/Presentation Guide for more information.
Access to Vaccine Supply
The US government is overseeing the distribution and coordination at this time. State and local authorities are responsible for the allocation of doses of populations in their jurisdictions. The CDC uses its current centralized distribution contract to fulfill orders for the most COVID-19 vaccine products and associated ancillary suppliers.6
Pfizer is currently coordinating with the US government and distribution partners to develop plans for future purchasing and distribution, with the hope that providers will be able to access the COVID-19 vaccines in a manner similar to how other Pfizer vaccines are currently purchased and received.7
In the future, Pfizer plans to announce the list price publicly 60 days prior to offering product for commercial sale.7
Diluent
Dosing and Administration
For dosage, preparation, and administration instructions for individuals 12 years of age and older, please refer to:
No. The monovalent*
*Monovalent refers to any authorized or approved
According to the vaccine Fact Sheets, there is no information on the co-administration of the
Also see the CDC's Summary Document for Interim Clinical Considerations for use of
Preparation of a dose is dependent on the cap color of the vaccine vial.
For Gray Cap vials, please see
The Gray Cap vaccine labeled "
Please see
- 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.
Yes. Safety and tolerability profile of the bivalent booster remains favorable and similar to the monovalent*
*Monovalent refers to any authorized or approved
- 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.
No. The monovalent*
*Monovalent refers to any authorized or approved
Storage and Handling
Cartons of
Once received, frozen vials may be immediately transferred to the refrigerator (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. A carton of 10 single dose vials may take up to 2 hours to thaw at this temperature. A carton of 10 multiple dose vials may take up to 6 hours to thaw at this temperature.5
Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90 °C to -60 °C (-130 °F to
If cartons of
Regardless of storage condition,
Thermal Shipping Container
If you are a healthcare professional trying to locate your order of the vaccine and you reside in the United States, you can call customer service at
If you are a healthcare professional having an issue with your shipment of the vaccine and you reside in the United States, you can call customer service at
After removal of the Temperature-Monitoring Device and Temperature-Monitoring Device Return Kit, the Single-Use Thermal Shipping Container should be disposed of at your facility. For detail on how to dispose of the Single-Use Thermal Shipping Container, please refer to the included Instructions.
- External Dimensions of the AeroSafe 47L7: 17.5" x 17.5" x 21.5"7
- External Dimensions of Softbox Medium ULT: 15.75" x 15.75" x 22.05"7
- Dimensions of one 10-pack carton: from approximately 3.35" x 1.46" x 1.85" to 3.50" x 1.46" x 1.85"7
- Dimensions of one 25-pack carton: 3.31" x 3.35" x 1.54"7
- Dimensions of one 196-pack carton:* 9.09" x 9.09" x 1.65"7
- Weight range for the Medium ULT thermal shipping containers: approximately 64 lb to 80 lb (29 kg to 36 kg)7
- External Dimensions of the Sonoco Gen 1 Single Use Thermal Shipper: ~17.125" x 16.125" x 19.125"7
- External Dimensions of the Sonoco Gen 2 Single Use Thermal Shipper: ~17.125" x 16.125" x 19.75"7
*Please note that dimensions can vary depending on the shipping mode or manufacturing site.
Ensuring Authenticity
Ensuring the Authenticity of
- 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 professional
- The vaccines are not taken orally and is not available in a capsule or tablet form
- 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 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 that are approved vaccinators. Individual doses are not for sale.
To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.
Administrative Information
The CPT code for
The CPT code for
The CPT code for the
The CPT code for the
The CPT code for COMIRNATY®
The CPT code for
New CPT codes are anticipated after the American Medical Association (AMA) publishes them. Please continue to check the AMA site for updated content: https://www.ama-assn.org/find-covid-19-vaccine-codes.
[By clicking the above link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.]
The NDC for a multiple dose vial of
The NDC for a multiple dose vial of
The NDC for a 10-pack carton of multiple dose vials of
The NDC for a multiple dose vial of
The NDC for 10-pack carton of multiple dose vials of COMIRNATY® (
The NDC for 10-pack carton of
The NDC for a single dose vial of
The NDC for a multiple dose vial of
Please note updated commercial NDCs will become available at time of transition to commercial market.
Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine, Bivalent; and Registered Trademark Name COMIRNATY®
-
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 professional5221,2
-
The vaccines are not taken orally and are not available in a capsule or tablet form5221,2
-
-
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 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, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccines can only be administered by licensed healthcare professionals, or other individuals that are approved vaccinators, at government-authorized vaccination sites. Individual doses are not for sale6,103,48,126,76,96,75,66,9
If you suspect the vaccine you have purchased may be counterfeit, contact us
at
To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.
-
Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap. Pfizer and BioNTech; December 8, 2022.
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Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; December 8, 2022.
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Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Bivalent (Original and Omicron BA.4/BA.5), (Booster Dose for 5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; December 8, 2022.
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Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; December 8, 2022.
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Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose for 12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; December 8, 2022.
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COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – October 29, 2020 Version 2.0. Centers for Disease Control and Prevention; 2020.
-
Data on file. Pfizer Inc. New York, NY.
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COVID-19 vaccines for people who are moderately or severely immunocompromised. Centers for Disease Control and Prevention. Accessed January 20, 2023. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html#print
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Centers for Medicare & Medicaid Services. COVID-19 vaccines and monoclonal antibodies. Accessed February 8, 2023. https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies
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McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2021.
Authorized Use
Indication & Authorized Use
Important Safety Information
Important Safety Information
Authorized Use
This EUA Prescribing Information pertains only to
Important Safety Information
Do not administer
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
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).
Myocarditis and Pericarditis
Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. 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
Limitation of Effectiveness
Adverse Reactions
The safety of a booster dose of
-
safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1),
- safety data from clinical trials which evaluated primary and booster vaccination with
Pfizer-BioNTech COVID-19 Vaccine, and - post marketing safety data with
Pfizer-BioNTech COVID-19 Vaccine.
The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with
The clinical study (30 mcg modRNA) that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).
In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of
In a clinical study (10 mcg modRNA) of participants 5 through 11 years of age, adverse reactions following administration of a single booster dose of
Post Authorization Experience
Before administration, please click to see:
EUA Fact Sheet for Vaccination ProvidersEUA Fact Sheet for Recipients and Caregivers
For More Information
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Information Updates
Emergency Use Authorization
Emergency uses of
Now Authorized: Effective 03/14/23
NOTE: The original monovalent Pfizer-BioNTech COVID-19 Vaccine was previously but is no longer authorized for use as the third dose of the primary series in individuals 6 months through 4 years of age.
Changes include but are not limited to the following sections:
New Language in Teal and Bold
2.3 Vaccination Schedule
. . .
Booster Dose
The
NOTE: The original monovalent
6 OVERALL SAFETY SUMMARY
. . .
The safety of
-
safety data from clinical studies which evaluated a booster dose of
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) in individuals 6 months of age and older, -
safety data from a clinical study which evaluated a booster dose with
Pfizer-BioNTech’s bivalentCOVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1) in individuals greater than 55 years of age,-
The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the
Pfizer-BioNTech COVID-19 Vaccine are relevant to thePfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
-
The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the
-
safety data from clinical studies which evaluated primary vaccination with
Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older and -
safety data from clinical studies which evaluated booster vaccination with
Pfizer-BioNTech COVID-19 Vaccine (previously, but no longer, authorized) in individuals 5 years of age and older, and -
postmarketing safety data with the
Pfizer-BioNTech COVID-19 Vaccine and thePfizer-BioNTech COVID-19 Vaccine, Bivalent
. . .
The
In a clinical study C4591048 (Study 6) in participants 6 through 23 months of age who received a booster (fourth dose) of
In a clinical study C4591048 (Study 6) in participants 2 through 4 years of age who received a booster (fourth dose) of
In a clinical study C4591048 (Study 6) in participants 5 through 11 years of age who received a booster (fourth dose) of
In a clinical study C4591044 (Study 5) in participants 12 years of age and older who received a booster (fourth dose) of
Verify the vials (including labels) prior to preparation and administration to help avoid dosing errors. Check gray cap, orange cap, and maroon cap vial labels to ensure that:
- For original monovalent vaccine, the name on the vial label states:
Pfizer-BioNTech COVID-19 Vaccine - For bivalent vaccine, the name on the vial label states:
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and OmicronBA.4/BA.5 )
Please see the Formulation/Presentation Guide for more details.
Presentation Guide
Regardless of storage condition, the maroon cap, orange cap, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vials and cartons.
