Questions and Answers About Pfizer-BioNTech
COVID-19 Vaccine for Ages 5 Through 11 Years
Approval and
Authorization Status
Access to Vaccine Supply
Diluent
Dosing and Administration
Storage and Stability
Dry Ice
Thermal Shipping Container
Ensuring Authenticity
Access to Vaccine Supply
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The US Government will oversee the distribution and coordination. State, local, and tribal authorities will be responsible for the allocation of doses to populations in their jurisdictions. The CDC will use its current centralized distribution contract
to fulfill orders for most
For product questions, please call
The CPT code for the Pfizer-BioNTech
The federal government has contracted with McKesson for purposes of vaccine distribution, such that no American will be charged for either the
Syringes and needles are included in the ancillary kits provided by CDC to its jurisdictions. The US Government is overseeing ancillary kit distribution and coordination through McKesson and will provide syringes and needles to meet state, local, and tribal authority vaccination needs. This includes sourcing and providing as many low dead-volume syringes and needles as possible to facilitate extracting the labeled number of doses from the multiple dose vials. For further information, please reach out to your state, local, or tribal health department, or the CDC.8
Please contact your Vaccine State Immunization Program Manager.
Diluent
The 6 months through 4 years of age,
The 12 years of age and older, DO NOT DILUTE, Gray Cap presentation does not require diluent and must NOT be diluted.3 For complete dose preparation and administration instructions, please refer to the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap.
For the 5 through 11 years of age,
Dilute the thawed vaccine by adding 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP, into the vial. Do not add more than 1.3 mL of diluent.1 Please see the Emergency Use Authorization (EUA) Fact Sheet for Vaccination
Providers (5 through 11 years of age),
The diluent will be packaged within the ancillary kits that may arrive 1 to 2 days before the vaccine shipment arrives.8
Diluent will be included in the ancillary kits provided by CDC to its jurisdictions. The US Government will oversee ancillary kit distribution and coordination, and will provide diluent to meet state, local, and tribal authority vaccination needs. If diluent has been damaged or lost, please call 1-800-666-7248.8
The 5 through 11 years of age,
-
Each dose must contain 0.2 mL of vaccine
-
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
-
Do not pool excess vaccine from multiple vials
Please see the Emergency Use Authorization (EUA) Fact Sheet
for Vaccination Providers
Yes, it is acceptable to use locally sourced sterile 0.9% Sodium Chloride Injection, USP. DO NOT use bacteriostatic saline.1
Dosing and Administration
Please see the
Emergency Use Authorization (EUA) Fact Sheet for
Vaccination Providers (5
through 11 years of age),
Yes, a third primary series dose of the vaccine administered at least 28 days following the second dose is authorized for emergency use in individuals 5 years of age and older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.1
Click here for complete dosing, preparation, and administration instructions for the
5 through 11 years of age,
No, the vaccine does not contain SARS-CoV-2 and cannot give one
Yes, when working with frozen individual vials, wear protective gloves in order to properly handle the vials.11
Each 0.2 mL dose of the 5 through 11 years of age,
Also see the CDC's Summary Document for Interim Clinical Considerations for use of
Please see the
Emergency Use Authorization (EUA) Fact
Sheet for
Vaccination Providers (5 through 11 years of age),
Please see the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (5 through 11 years of age),
Please see the
Emergency Use Authorization (EUA) Fact Sheet for
Vaccination Providers (5 through 11 years of age),
A third dose of the vaccine (0.2 mL) administered at least 28 days following the first 2 doses of this vaccine is authorized for administration to individuals 5 through 11 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Please see the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (5 through 11 years of age),
Before administration of the vaccine, please click to see
Full Prescribing Information (12 years of age and older),
EUA Fact Sheet for Vaccination Providers (12 years of age and older),
EUA Fact Sheet for Vaccination Providers (12 years of age and older),
Recipients and Caregivers Fact Sheet (12 years of age and older)
Storage and Stability
Orange Cap presentation vials stored?
Alternatively, frozen vials may be stored in an ultra-low-temperature freezer at -90°C to -60°C (-130°F
Cartons of Pfizer-BioNTech

Storage options for 5
through 11 years of age,
Orange Cap presentation:


Regardless of storage condition, orange cap vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 12 months from the date of manufacture are shown below.1
Printed Manufacturing Date | 12-Month Expiry Date |
---|---|
07/2021 | 30-Jun-2022 |
08/2021 | 31-Jul-2022 |
09/2021 | 31-Aug-2022 |
10/2021 | 30-Sep-2022 |
11/2021 | 31-Oct-2022 |
12/2021 | 30-Nov-2022 |
01/2022 | 31-Dec-2022 |
02/2022 | 31-Jan-2023 |
The 5 through 11 years of age,
Alternatively, frozen vials may be stored in an ultra-low-temperature freezer at -90°C to -60°C (-130°F
Cartons of Pfizer-BioNTech

Storage options for 5
through 11 years of age,
Orange Cap presentation:


Printed Manufacturing Date | 12-Month Expiry Date |
---|---|
07/2021 | 30-Jun-2022 |
08/2021 | 31-Jul-2022 |
09/2021 | 31-Aug-2022 |
10/2021 | 30-Sep-2022 |
11/2021 | 31-Oct-2022 |
12/2021 | 30-Nov-2022 |
01/2022 | 31-Dec-2022 |
02/2022 | 31-Jan-2023 |
The vaccine supply you received was shipped in 1 of 2 types of containers: a Medium (Reusable) Thermal Shipping Container or a Single-Use Thermal Shipping Container.
The type of thermal shipping container you received is labeled on the outside of the box as either “Medium ULT” (or otherwise indicates “Do Not Discard”), or “Single-Use ULT.” Look for this label in order to
determine the type of container you have received. Only the
Medium ULT may be used as temporary storage of the vaccine for up to 30 days. If you are using the Medium ULT as temporary storage, the container must be opened, inspected, and replenished with dry ice within 24 hours of receipt.11 Refer to the Dry Ice Replenishment
Instructions packed in the thermal shipping container (or download here) for instructions regarding the use of the thermal shipping container for temporary
storage of your vaccine supply.
The Single-Use ULT cannot be used as temporary storage due to its design. Upon delivery of this type of container, follow instructions for
proper disposal of the Single-Use ULT shipping container, available from cvdvaccine-us.com.
The Single-Use Thermal Shipping container cannot be used as temporary storage.
After use, the Medium Thermal Shipping Container, including the Temperature-Monitoring Device, must be returned to the supplier to help Pfizer fulfill its commitment to reusable resources. Please refer to the Return Instructions available on cvdvaccine-us.com for more information.
*This information is based on the data provided by the vendors listed. By including them, Pfizer is not endorsing the vendors nor making guarantees about their products. Please contact the vendor directly for availability. If you are a vendor and would like to add, edit, or delete your information, please call
If you are a healthcare professional residing in the US and have questions about using the vaccine, call
-
10-pack cartons may take up to 4 hours to thaw
Dry Ice
Only Medium Thermal Shipping Containers can be replenished with dry ice and used for temporary storage.11
The Single-Use Thermal Shipping Container cannot be used as temporary storage.
The Single-Use Thermal Shipping Container cannot be used as temporary storage.
For more information, please see the Dry Ice Replenishment Instructions for Medium (Reusable) Thermal Shipping Containers.
*This information is based on the data provided by the vendors listed. By including them, Pfizer is not endorsing the vendors nor making guarantees about their products. Please contact the vendor directly for availability. If you are a vendor and would like to add, edit, or delete your information, please call
The Single-Use Thermal Shipping Container cannot be used as temporary storage.
For more information, please see the Dry Ice Replenishment Instructions for Medium (Reusable) Thermal Shipping Containers.
Thermal Shipping Container
Ensure the Dry Ice UN1845 markings and diamond-shaped Class 9 hazard label on the thermal shipping container are covered by placing a blank label over them in preparation for the return, as the container no longer contains dry ice. Blank sticker labels to place over the UN1845 markings can be found on the back page of the Shipping and Handling Guidelines included in the thermal shipping container. A label may also be found on the inside flap of some thermal shipping containers. You can contact the carrier identified on the return label to arrange the return.11
Please refer to the Return Instructions for complete information.
For additional assistance on returns, call 1-701-540-4039 if in the US.
For complete instructions on how to return the Temperature-Monitoring Device using the included Temperature-Monitoring Device Return Kit, please refer to the Return Instructions. Do not return the vaccine or vaccine vials.
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 complete instructions on how to dispose of the Single-Use Thermal Shipping Container, please refer to the Return Instructions.
You will automatically receive a shipment delivery email from Controlant, the temperature-monitoring device company. This email will include a Quality Disposition Report, which will confirm the product disposition and actions required if the status light is red.11
Do not use product until you have received the Quality Disposition Report from Controlant advising on further use.
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External Dimensions of the AeroSafe 47L7: 17.5" x 17.5" x 21.5"
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External Dimensions of Softbox Medium ULT: 15.75" x 15.75" x 22.05"
-
Dimension of one 10-pack carton: from approximately 3.35" x 1.46" x 1.85" to 3.50" x 1.46" x 1.85"
-
Dimension of one 25-pack carton: 3.31" x 3.35" x 1.54"
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Weight range for the Medium ULT thermal shipping containers: approximately 64 lb to 80 lb (29 kg to 36 kg)
-
External Dimensions of the Sonoco Single Use Thermal Shipper: ~17.32" x 16.18" x 18.94"
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External Dimensions of the CCT Single Use Thermal Shipper: ~19.76" x 15.75" x 15.51"
Ensuring Authenticity
-
Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccine, including how it is 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 vaccine is only administered intramuscularly by a healthcare professional1
-
The vaccine is not taken orally and is 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 are dispensed in a vial as follows:
-
For 6 months through 4 years of age,
DILUTE BEFORE USE Maroon Cap vials, the vial label includes a maroon border4 -
For 5 through 11 years of age,
DILUTE BEFORE USE Orange Cap vials , the vial label includes an orange border1 -
For 12 years of age and older, DO NOT DILUTE, Gray Cap vials , the vial label includes a gray border3
-
For 12 years of age and older,
DILUTE BEFORE USE Purple Cap vials . Two versions of the vial label are in current circulation—with or without a purple border2
-
Ensure the safety 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 government-authorized vaccination centers—such as doctor’s offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccine 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 sale 8,12
If you suspect the vaccine you have purchased may be counterfeit, contact us at1-800-438-1985 or visit https://www.pfizer.com/products/product-contact-information.
To learn more visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.
10-pack cartons:

The 5 through 11 years of age and older,
5 through 11 years of age,

Ensuring the Authenticity of BioNTech and Pfizer's COVID-19 Vaccines
-
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 are dispensed in a vial as follows:
-
For 6 months through 4 years of age, DILUTE BEFORE USE, Maroon Cap vials, the vial label includes a maroon border546
-
For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border15
-
For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border34
-
For 12 years of age and older, DILUTE BEFORE USE, Purple Cap vials. Two versions of the vial label are in current circulation - with or without a purple border23
-
-
Ensure the safety 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 government-authorized vaccination 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 sale6,78,128,128,99,13
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. 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 ; October 12, 2022. - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap.
Pfizer and BioNTech ; October 18, 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 ;August 31, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. 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 ; August 31, 2022 - Understanding the regulatory terminology of potential preventions and treatments for COVID-19. US Food & Drug Administration. Accessed December 10, 2021. https://www.fda.gov/consumers/consumer-updates/understanding- regulatory-terminology-potential-preventions-and-treatments-covid-19
- COMIRNATY® (
COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; July 8, 2021. - COMIRNATY® (
COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; July 8, 2021. - COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
- Biden administration purchases additional doses of COVID-19 vaccines from Pfizer and Moderna. US Department of Health & Human Services. Accessed August 16, 2021. https://www.hhs.gov/about/news/2021/02/11/biden- administration-purchases-additional-doses-covid-19-vaccines-from-pfizer-and-moderna.html
- Myths and facts about COVID-19 vaccines. Centers for Disease Control and Prevention. Accessed August 11, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html
- Data on file. Pfizer Inc. New York, NY.
- Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Centers for Disease Control and Prevention. Accessed March 2, 2022. https://www.cdc.gov/vaccines/covid-19/ clinical-considerations/covid-19-vaccines-us.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2F vaccines%2Fcovid-19%2Finfo-by-product%2Fclinical-considerations.html%5D.
- McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.