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Frequently Asked Questions

Orange Cap Vial Image

5 through 11 years of age,
DILUTE BEFORE USE
(Orange Cap)

FDA AUTHORIZED FOR EMERGENCY USE1-4

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. The emergency uses are 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.

Questions and Answers About Pfizer-BioNTech COVID-19 Vaccine for Ages 5 Through 11 Years

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Approval and Authorization Status

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What is the difference between FDA approval and an Emergency Use Authorization (EUA)?

When the FDA approves a vaccine, it means they have determined, based on substantial evidence, that it is effective for its intended use, and that its benefits outweigh its risks when used according to the product’s approved labeling.5


According to the FDA, “During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives."5

For whom is the vaccine FDA approved or authorized?
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine that has been approved as a two-dose primary series 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.6,7 The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from the FDA to prevent COVID-19 in individuals 6 months of age and older.1-4 Please see below for a list of authorized emergency uses.

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.


Because of the potential for vaccine administration errors, including dosing errors, COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine presentations should only be used for the ages specified on the vial labels, cartons or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.


For vaccination of individuals advancing into the next age group (4 years of age turning 5 years of age or 11 years of age turning 12 years of age) between any primary series dose, refer to the respective age-based Fact Sheet for Healthcare Providers for instructions for administration.


COMIRNATY® (COVID-19 Vaccine, mRNA) is authorized for emergency use to provide:

  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 to provide:

  • a 3-dose 3 mcg modRNA primary series to individuals 6 months through 4 years of age
  • a 2-dose 10 mcg modRNA primary series to individuals 5 through 11 years of age
  • a 2-dose 30 mcg modRNA primary series to individuals 12 years of age and older
  • a third 10 mcg modRNA primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise
  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a single 10 mcg modRNA booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

For information on booster dose eligibility in individuals 5 through 11 years of age, please refer to EUA Fact Sheet for Vaccination Providers (5 Through 11 years), DILUTE BEFORE USE, Orange Cap, or click here.

For information on vaccine eligibility in individuals 6 months through 4 years of age, please refer to EUA Fact Sheet for Vaccination Providers (6 Months Through 4 Years), DILUTE BEFORE USE, Maroon Cap.
In the clinical trial, what was the efficacy & safety of the vaccine?

Please see the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap to see the to see clinical trial design, safety, and efficacy information.

Access to Vaccine Supply

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How can I order the vaccine for my practice, office, or hospital?

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 COVID-19 vaccine products and associated ancillary supplies.8

Whom can I call with product questions?

For product questions, please call 1-877-829-2619.

What is the Current Procedural Terminology (CPT) code?

The CPT code for the Pfizer-BioNTech COVID-19 Vaccine (5 through 11 years of age) DILUTE BEFORE USE, Orange Cap presentation is 91307. The administrative code is 0071A for the first dose, 0072A for the second dose, and 0073A for the third dose.

What is the cost of the vaccine?

The federal government has contracted with McKesson for purposes of vaccine distribution, such that no American will be charged for either the COVID-19 vaccine or its distribution.9

Who will provide the syringes and needles?

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

Whom do I contact if my ancillary kit is damaged or lost?

Please contact McKesson Customer Service:

Phone #: 833-272-6634

Email: [email protected]

Whom do I contact if supplies in the ancillary kit are missing or damaged when opening the shipment?

Please contact McKesson Customer Service:

Phone #: 833-272-6634

Email: [email protected]

Whom do I contact for additional ancillary kit supplies (eg, vaccination cards, syringes, and/or needles)?

Please contact your Vaccine State Immunization Program Manager.

Diluent

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Which vaccine presentations require diluent?

The 6 months through 4 years of age, DILUTE BEFORE USE, Maroon Cap presentation, the 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation, and the 12 years of age and older, DILUTE BEFORE USE, Purple Cap presentation require diluent.1,2,4 For complete dose preparation and administration instructions, please refer to the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap, the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap, and the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap,


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.

What type of diluent should I use with the 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation?

For the 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation, dilute only with sterile 0.9% Sodium Chloride Injection, USP. DO NOT USE bacteriostatic saline.1

How do I dilute the 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation for administration?

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), DILUTE BEFORE USE, Orange Cap and refer to the DOSAGE AND ADMINISTRATION section for specific guidelines on preparation of the vaccine.

Will the vaccine be supplied and shipped with the diluent?

The diluent will be packaged within the ancillary kits that may arrive 1 to 2 days before the vaccine shipment arrives.8

How can I order more diluent?

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

How many doses does each vial contain?

The 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation 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 needle1:

  • 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 (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap and refer to the DOSAGE AND ADMINISTRATION section for instructions on preparation and administration.

Can I use locally sourced diluent?

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), DILUTE BEFORE USE, Orange Cap for dosage, preparation, and administration for individuals 5 through 11 years of age.

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Are individuals 5 through 11 years of age eligible for a booster dose under the Emergency Use Authorization?

Yes, a single booster dose (0.2 mL) of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.1


For more information on booster dose eligibility in individuals 5 through 11 years of age, please refer to the EUA Fact Sheet for Vaccination Providers (5 Through 11 Years), DILUTE BEFORE USE, Orange Cap, or click here.


For additional information related to administration of booster doses in immunocompromised individuals, see Select Information Related to Dosing Intervals for the Pfizer-BioNTech COVID-19 Vaccine.

Can immunocompromised patients receive a third dose?

Yes, a third 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, DILUTE BEFORE USE, Orange Cap presentation.

Does the vaccine contain live virus?

No, the vaccine does not contain SARS-CoV-2 and cannot give one COVID-19.10

Do I need to wear gloves when handling frozen individual vials?

Yes, when working with frozen individual vials, wear protective gloves in order to properly handle the vials.11

What are the ingredients included in the 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation?

Each 0.2 mL dose of the 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation contains 10 mcg of modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each 0.2 mL dose of the vaccine also includes the following ingredients: lipids (0.14 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine hydrochloride. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium chloride per dose. 1

Can I give the vaccine at the same time as other vaccines?
According to the vaccine Fact Sheets, there is no information on the co-administration of this vaccine with other vaccines.1

Also see the CDC's Summary Document for Interim Clinical Considerations for use of COVID-19 Vaccines Currently Authorized in the United States.
Is the vaccine only available in a multiple dose vial?
Yes, the vaccine is only available in multiple dose vials.1
How do I prepare the dose?

Please see the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap DOSAGE AND ADMINISTRATION section for instructions on how to prepare the vaccine.

What syringes should I use for diluting?
A 3 mL syringe should be used for diluent withdrawal and mixing. A 5 mL syringe is also acceptable.11

Please see the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap DOSAGE AND ADMINISTRATION section for instructions on vaccine preparation.
What syringes and needles should I use for administration?
Use a 1 mL syringe. Low dead-volume syringes and/or needles should be used. If standard syringes and needles are used, there may not be sufficient volume to extract the labeled number of doses from a single vial. If a low dead-volume syringe is not available, a standard 1 mL syringe may be used.11

Please see the Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap DOSAGE AND ADMINISTRATION section for instructions on vaccine preparation.

What is the primary dosing schedule for the vaccine for individuals 5 through 11 years of age?
In individuals 5 through 11 years of age, the vaccine is administered as a primary series of 2 doses (0.2 mL each) 3 weeks apart.1

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), DILUTE BEFORE USE, Orange Cap DOSAGE AND ADMINISTRATION section for instructions on preparation, administration, and adverse event reporting requirements. Please also see the Safety Information for the vaccine.

Before administration of the vaccine, please click to see

Are the FDA-approved COMIRNATY® ( COVID-19 Vaccine, mRNA) and EUA-authorized Pfizer-BioNTech COVID-19 Vaccine interchangeable?
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns. COMIRNATY® ( COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older (purple cap and gray cap) should not be used for individuals 5 through 11 years of age because of the potential for vaccine administration errors, including dosing errors.
Are Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY® interchangeable with other COVID-19 vaccines?
According to the CDC Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, in general, the same mRNA vaccine product (ie, the same manufacturer) should be used for all doses in the primary series, including an additional primary dose.12

According to the vaccine Fact Sheets, a single booster dose may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.2,3

Booster Information

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Are individuals 5 through 11 years of age eligible for a booster dose under the Emergency Use Authorization?

Yes, a single booster dose (0.2 mL) of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.1


For more information on booster dose eligibility in individuals 5 through 11 years of age, please refer to the EUA Fact Sheet for Vaccination Providers (5 Through 11 Years), DILUTE BEFORE USE, Orange Cap, or click here.


For additional information related to administration of booster doses in immunocompromised individuals, see Select Information Related to Dosing Intervals for the Pfizer-BioNTech COVID-19 Vaccine.

Storage and Stability

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How are 5 through 11 years of age, DILUTE BEFORE USE,
Orange Cap
presentation vials stored?
The 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials may arrive frozen at ultra-cold conditions in thermal shipping containers with dry ice. 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 vials may take up to 4 hours to thaw at this temperature.1

Alternatively, frozen vials may be stored in an ultra-low-temperature freezer at -90°C to -60°C (-130°F to -76°F) for up to 12 months from the date of manufacture. Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.

Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may also arrive at 2°C to 8°C. If received at 2°C to 8°C, they should be stored at 2°C to 8°C. Total cumulative time the vials are stored at 2°C to 8°C (35°F to 46°F ) should not exceed 10 weeks. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

faq-orange-image

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

Storgae-orange-Dilution Storage-purple-Dilution

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
If you have lots that will expire shortly, please see additional information about expiry dates.
Do I need to store the 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation vials in an ultra-low-temperature freezer?

The 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials may arrive frozen at ultra-cold conditions in thermal shipping containers with dry ice. 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 vials may take up to 4 hours to thaw at this temperature. 1

Alternatively, frozen vials may be stored in an ultra-low-temperature freezer at -90°C to -60°C (-130°F to -76°F) for up to 12 months from the date of manufacture. Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.

Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may also arrive at 2°C to 8°C. If received at 2°C to 8°C, they should be stored at 2°C to 8°C. Total cumulative time the vials are stored at 2°C to 8°C (35°F to 46°F ) should not exceed 10 weeks. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

faq-orange-image

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

Storgae-orange-Dilution Storage-purple-Dilution
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
If you have lots that will expire shortly, please see additional information about expiry dates.
How do I know if the thermal shipping container I received with my vaccine shipment can be used as temporary cold storage?

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.

How do I know when my vials expire?
Please click here for expiry information.
Can I still use the product if it has become frozen after it is originally thawed?
No, you should not use the vaccine if it has become frozen after thawing. The vaccine must then be discarded in a sharps container.13 If you are a healthcare professional in the US and want additional information, visit https://www.pfizermedicalinformation.com/en-us/pfizer-biontech-covid-19-vaccine or call 1-800-438-1985 to talk to a Pfizer Medical Information representative.
How long can I store the vaccine in the Medium Thermal Shipping Container?
With proper dry ice replenishment, the Medium Thermal Shipping Container may be used as temporary storage for up to 30 days from delivery.11 Please see Shipping and Handling Guidelines for the Medium Thermal Shipping Container for more information.

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.
Where can I get an ultra-low-temperature freezer?
Ultra-low-temperature freezer vendors* include but are not limited to Thermo Fisher Scientific, Haier Biomedical, and Stirling Ultracold.

*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 1-877-829-2619 .
Is there preservative in the vaccine?
No, the vaccine does not contain preservative.1
Can I still use the product if it has been exposed to light?
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Thawed vials can be handled in room light conditions.1

If you are a healthcare professional residing in the US and have questions about using the vaccine, call 1-800-438-1985 to talk to a Pfizer Medical Information Specialist or go to https://www.pfizermedicalinformation.com/en-us/pfizer-biontech-covid-19-vaccine for more information.
How long does it take for frozen 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation vials to thaw?
In the refrigerator at 2°C to 8°C (35°F to 46°F)1:
  • 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 [77°F]) for 30 minutes.
Are components of the vaccine vial made with latex?
The vial stoppers are not made with natural rubber latex.1

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.

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Do I still need to monitor the temperature if I am using dry ice?
Yes, the temperature of vaccine product must always be monitored in accordance with local requirements.11 Please refer to the CDC’s Vaccine Storage and Handling Toolkit for guidance on storage and handling of vaccines at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.
How often do I need to add dry ice to the thermal shipping container?
If you are using the Medium Thermal Shipping Container as temporary storage, the container must be opened, inspected, and replenished with dry ice within 24 hours of receipt. Do not open the vial cartons or remove vials until you are ready for thawing or use. It is recommended that the thermal shipping container not be opened more than 2 times a day and should not be opened for more than 3 minutes at a time. If these guidelines are followed, the thermal shipping container should be replenished with dry ice every 5 days. If the thermal shipping container is opened more frequently, replenishment will need to occur more often.11 Please refer to the Storage & Handling section for instructions for replenishing dry ice.

The Single-Use Thermal Shipping Container cannot be used as temporary storage.
How do I refill the Medium Thermal Shipping Container with dry ice?
Fill any low areas in the side compartments of the thermal shipping container with dry ice pellets until completely filled, so that it is equal with but does not exceed the top edges of the box that holds the vial cartons. Reinsert the dry ice pod on top of the box that holds the vial cartons. Then fill the dry ice pod to the top with dry ice (do not overfill).11

For more information, please see the Dry Ice Replenishment Instructions for Medium (Reusable) Thermal Shipping Containers.
Where and how can I get more dry ice?
Dry ice vendors* include but are not limited to Airgas, Linde, Continental Carbonic Products Inc, and Matheson.11

*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 1-877-829-2619 .
Is there a limit to how long I can use dry ice to maintain temperature, and how many times can I refill the container with dry ice?
The Medium Thermal Shipping Container may be used as temporary storage for up to 30 days from delivery. It is recommended that the thermal shipping container not be opened more than 2 times a day, and shouldn’t be opened for more than 3 minutes at a time. If these guidelines are followed, after dry ice replenishment within 24 hours, the thermal shipping container should then be replenished with dry ice every 5 days. If the thermal shipping container is opened more frequently, replenishment will need to occur more often.11

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.
What type of protective gear should be worn when handling dry ice?
Wear safety goggles or safety glasses with side shields and waterproof insulated gloves for handling dry ice.13 Click here to view the Dry Ice Safety Data Sheet.
How do I dispose of dry ice when I no longer need it?
Dry ice can be hazardous. Take necessary precautions by reviewing the Dry Ice Safety Data Sheet in the Resources and consulting with your Occupational Health Department. To discard the dry ice, open the thermal shipping container and leave it at room temperature in a well-ventilated area. The dry ice will sublime from a solid to a gas.11
What type of gloves should I use when transferring vial cartons from the thermal shipping container?
Wear waterproof insulated gloves to prevent skin contact while transferring vial cartons from the thermal shipping container.11

Thermal Shipping Container

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How do I follow up on the status of my product order?
If you are a healthcare professional trying to locate your order of the vaccine and you reside in the US, you can call 1-800-666-7248.
Whom do I contact if I have an issue with my shipment?
If you are a healthcare professional having an issue with your shipment of the vaccine and you reside in the US, you can call 1-800-666-7248.
What type of gloves should I use when transferring vial cartons from the thermal shipping container?
Wear waterproof insulated gloves to prevent skin contact while transferring vial cartons from the thermal shipping container.11
How can I return the Medium Thermal Shipping Container and Temperature-Monitoring Device?
To return the Medium Thermal Shipping Container and Temperature-Monitoring Device, use the preprinted return shipping label included inside the container and apply over the existing shipping label. Some thermal shipping containers have the preprinted return shipping label already adhered to the flap of the thermal shipping container. After the thermal shipping container is no longer needed to store the vaccine, you should discard the dry ice. To discard, open the thermal shipping container and leave it at room temperature in a well-ventilated area. The dry ice will sublime from a solid to a gas. Take necessary precautions by reviewing the Dry Ice Safety Data Sheet and consulting with your Occupational Health Department.11

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.
How can I return Temperature-Monitoring Device included with the Single-Use Thermal Shipping Container?
Remove the Temperature-Monitoring Device Return Kit from the flap of the Single-Use Thermal Shipping Container. Then, gently remove the Temperature-Monitoring Device with the probe from the foam lid (or foam compartment on box flap) and payload area.11

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.
How should I handle the dry ice inside the thermal shipping container?
Dry ice can be hazardous. Take necessary precautions by reviewing the Dry Ice Safety Data Sheet, and consulting with your Occupational Health Department. Ensure there is proper ventilation and wear safety goggles or safety glasses with side shields and waterproof insulated gloves when working with dry ice.10 Please visit the Storage & Handling section for step-by-step instructions for safely handling the thermal shipping container.
The Controlant Real-Time Monitor status light is red. What should I do?
When the shipment status light is red, this means that the device is functioning properly but has recorded an out-of-range temperature.11

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.
Can I use the Controlant Real-Time Monitor to monitor the vaccine temperature while using the thermal shipping container as my storage unit?
Yes, you will be able to use the temperature-monitoring device to monitor the vaccine temperature.11 Contact Controlant customer service at: 1-701-540-4039 or visit https://in.controlant.com/onsitemonitoring to access the Controlant Onsite Monitoring Playbook and instructional videos.
What are the weights and dimensions of the thermal shipping container and vial cartons?
  • External Dimensions of the AeroSafe 47L7: 17.5" x 17.5" x 21.5"
  • 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"
  • 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"
  • External Dimensions of the CCT Single Use Thermal Shipper: ~19.76" x 15.75" x 15.51"

Ensuring Authenticity

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How can I verify if the vaccine product I receive is authentic?
Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine and Registered Trademark Name COMIRNATY®
  • 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 at 1-800-438-1985 or visit https://www.pfizer.com/products/product-contact-information.

    To learn more visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.
What do the cartons and vials look like?

10-pack cartons:

10 Pack Carton

The 5 through 11 years of age and older, DILUTE BEFORE USE, Orange Cap presentation vaccine is contained in 2 mL type 1 glass preservative-free multiple dose vials with 1.3 mL of frozen liquid drug product1,11:

5 through 11 years of age, DILUTE BEFORE USE, Orange Cap presentation vial:

Presentation Vial
What is the NDC?
The NDC for Pfizer-BioNTech COVID-19 Vaccine vials with an orange cap supplied in a carton containing 10 multiple dose vials is 59267-1055-4 .

Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine and Registered Trademark Name COMIRNATY®

  • 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 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 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 sale6,78,128,128,99,13

If you suspect the vaccine you have purchased may be counterfeit, contact us at 1-800-438-1985 or visit https://www.pfizer.com/products/product-contact-information.

To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.


References
  1. 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; June 17, 2022.
  2. 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; July 8, 2022.
  3. 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; July 8, 2022.
  4. 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; June 17, 2022
  5. 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
  6. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; July 8, 2021.
  7. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; July 8, 2021.
  8. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  9. 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
  10. 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
  11. Data on file. Pfizer Inc. New York, NY.
  12. 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.
  13. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

Indication & Authorized Use

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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Indication & Authorized Use


COMIRNATY® (COVID-19 Vaccine, mRNA) 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 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

Pfizer-BioNTech COVID-19 Vaccine

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Because of the potential for vaccine administration errors, including dosing errors, vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use under an Emergency Use Authorization (EUA) 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.



Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of these vaccines.

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 Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

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 the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and 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 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, 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 Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Limitation of Effectiveness

Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.

Adverse Reactions

Primary Series Adverse Events:

Pfizer-BioNTech COVID-19 Vaccine

In a clinical study (3 mcg modRNA) in participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (3 mcg modRNA) in participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY

In clinical studies (30 mcg modRNA) of adolescents 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) were 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%), and injection site redness (8.6%).

In clinical studies (30 mcg modRNA) 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 (30 mcg modRNA) 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%).

Booster Dose Adverse Events:

Pfizer-BioNTech COVID-19 Vaccine

In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).

Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY

In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent is based on:

  • 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 Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants 55 years of age and older. 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 of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Pfizer-BioNTech COVID-19 Vaccine and post authorization use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Before administration of Pfizer-BioNTech COVID-19 Vaccine, please click to see







For More Information

Medical Information Medical Information

Medical Information

Visit PfizerMedicalInformation.com
or call 1-800-438-1985

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General Product Inquiries

Call 1-877-829-2619

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