Questions and Answers About Pfizer-BioNTech
COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for Ages 5 Through 11 Years
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
Yes. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is authorized for emergency use in individuals 5 through 11 years of age and older as a single booster dose administered at least 2 months after either3:
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completion of primary vaccination with any authorized or approved COVID-19 vaccine, or
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receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine
*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.
Please see
Because both the monovalent* Pfizer-BioNTech COVID-19 Vaccine vial label and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) presentations of 5 through 11 years of age, DILUTE BEFORE USE vaccine vials have orange caps and labels with an orange border, it is important to look closely at the label itself to determine which of the Orange Cap vaccines you intend to administer.2,3
*Pfizer-BioNTech
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) authorized for use in individuals 5 through 11 years of age has an orange cap and label with orange border and includes the following:
The monovalent
Please see the Formulation/Presentation Guide for more information.
Access to Vaccine Supply
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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
For product questions, please call customer service at
The federal government has contracted with McKesson for purposes of vaccine distribution, such that no American will be charged for either the
In the future, Pfizer plans to announce the list price publicly 60 days prior to offering product for commercial sale.7
Diluent
Yes.3 Please see Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.5/BA.5) EUA Fact Sheet for Vaccination Providers (Booster Dose 5 through 11 years of age), DILUTE BEFORE USE, Orange Cap and refer to the DOSAGE AND ADMINISTRATION section, as well as the Dosing & Preparation page on the website for instructions on how to prepare the vaccines.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap contains 10 doses of 0.2 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle3:
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Each dose must contain 0.2 mL of vaccine
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If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume
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Do not pool excess vaccine from multiple vials
Please see Pfizer-BioNTech
Dosing and Administration
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A single booster dose (0.2 mL) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine.3
*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.
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 COVID-19 Vaccines Currently Authorized in the United States. [By clicking this 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.]
Yes.3
Preparation of a dose is dependent on the presentation, which can be identified based on the labeling and cap color of the vaccine vial.
For Orange Cap vials, please see Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.5/BA.5) EUA Fact Sheet for Vaccination Providers (Booster Dose 5 through 11 years of age), DILUTE BEFORE USE, Orange Cap DOSAGE AND ADMINISTRATION section for instructions on how to prepare the vaccine.
Please see Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.5/BA.5) EUA Fact Sheet for Vaccination Providers (Booster Dose 5 through 11 years of age), DILUTE BEFORE USE, Orange Cap to see the clinical trial design and safety information.
Storage and Handling
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Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90 °C to -60 °C (-130 °F to
Storage options for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap3:
Visit https://lotexpiry.cvdvaccine.com/ for lot expiry information for BioNTech and Pfizer's
In the refrigerator at 2 °C to 8 °C (35 °F to 46 °F) 3:
- 10-pack cartons may take up to 4 hours to thaw
Individual vials will take less time. If needed, a frozen vial may be thawed at room temperature (up to 25 °C [
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 1-800-666-7248.
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 1-800-666-7248.
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.
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External Dimensions of the AeroSafe 47L7: 17.5" x 17.5" x 21.5"8
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External Dimensions of Softbox Medium ULT: 15.75" x 15.75" x 22.05"8
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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"8
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Dimensions of one 25-pack carton: 3.31" x 3.35" x 1.54"8
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Weight range for the Medium ULT thermal shipping containers: approximately 64 lb to 80 lb (29 kg to 36 kg)8
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External Dimensions of the Sonoco Gen 1 Single Use Thermal Shipper: ~17.125" x 16.125" x 19.125"8
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External Dimensions of the Sonoco Gen 2 Single Use Thermal Shipper: ~17.125" x 16.125" x 19.75"8
*Please note that dimensions can vary depending on the shipping mode or manufacturing site.
Ensuring Authenticity
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- 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
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The vaccines are only administered intramuscularly by a healthcare professional
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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
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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®
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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 professional3221,2
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The vaccines are not taken orally and are not available in a capsule or tablet form3221,2
-
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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 sale6,93,48,126,76,96,75,66,9
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.
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Pfizer-BioNTech COVID-19 Vaccine andPfizer-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. -
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. -
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. -
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.
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Data on file. Pfizer Inc. New York, NY.
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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.
