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EUA FACT SHEETS

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet for Recipients and Caregivers

Questions and Answers About Pfizer-BioNTech COVID-19 Vaccine

What is Emergency Use Authorization?

According to the FDA's Emergency Use Authorization (EUA) website, "The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN* threats by facilitating the availability and use of MCMs† needed during public health emergencies. Under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”

Click here for the FDA Emergency Use Authorization Letter.

*Chemical, biological, radiological, and nuclear.
†Medical countermeasure.

Access to Vaccine Supply

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How can I order the Pfizer-BioNTech COVID-19 Vaccine for my practice, office, or hospital?

The U.S. Government will oversee the Pfizer-BioNTech COVID-19 Vaccine 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.

Who will receive the Pfizer-BioNTech COVID-19 Vaccine first?

The CDC's Advisory Committee on Immunization Practices has prioritized healthcare personnel and residents of long-term care facilities for Phase 1a of COVID-19 vaccination. Click here to view the Morbidity and Mortality Weekly Report (MMWR) and ACIP recommendations.

How many doses will be available?

The vaccine supply may be limited as manufacturing increases to meet demand.

Whom can I call with product questions?

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

What is the procedural coverage coding?

The CPT code for the Pfizer-BioNTech COVID-19 Vaccine is 91300. The administrative code is 0001A for the first dose, and 0002A for the second dose.

What is the cost of the Pfizer-BioNTech COVID-19 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.

Administration

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Please see the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) for dosage preparation and administration.

How many doses are in each diluted vial?

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Do not pool excess vaccine from multiple vials

What are the ingredients included in the vaccine?

Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
It also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N, N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

Can I give the Pfizer-BioNTech COVID-19 Vaccine at the same time as other vaccines?

There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

How do I prepare the dose?

Please see the Dosing & Administration section of this website for instructions on how to prepare the Pfizer-BioNTech COVID-19 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. Please see the Dosing & Administration section for instructions on vaccine preparation.

What syringes should I use for administration?

Preferentially, a 1 mL low dead-volume syringe, rather than a standard 1 mL syringe, should be used for administration. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. If a low dead-volume syringe is not available a standard 1 mL syringe may be used. Please see the Dosing & Administration section for instructions on vaccine administration.

What is the dosing schedule for the vaccine?

The vaccine is given as a series of 2 doses 3 weeks apart. Please see the Dosing & Administration section for instructions on preparation, administration, and adverse event reporting requirements, as well as Safety Information for the vaccine.

Are COVID-19 vaccines interchangeable?

There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.

Storage and Stability

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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. If you are a healthcare professional in the U.S. 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 vials in the dry ice shipping container?

With proper dry ice replenishment, the thermal shipping container may be used as temporary storage for up to 30 days from delivery. Please visit the Product Storage & Dry Ice section.

How is the vaccine stored?

Upon delivery, immediately store frozen multiple dose vaccine vials in an ultra-low-temperature freezer. A second option is to use your thermal shipping container as temporary storage, if it is consistently replenished with dry ice. Lastly, the vaccine may be stored in the refrigerator at 2°C to 8°C for 120 hours (5 days) but cannot be re-frozen. Please visit the Product Storage & Dry Ice section for guidelines on maintaining the correct temperature.

At what temperature does the vaccine need to be stored?

Vaccine vials are to be stored in an ultra-low-temperature (ULT) freezer between -80°C and -60°C (-112°F to -76°F), protected from light and kept in the original packaging. The thermal shipping container in which the vaccines arrive can be used as temporary storage. The thermal shipping container maintains a temperature range of ‑90°C to ‑60°C (-130°F to ‑76°F). Storage within this temperature range is not considered an excursion from the recommended storage condition.

The vaccine may be stored in the refrigerator at 2°C to 8°C for 120 hours (5 days) but cannot be re-frozen.

Do I need to have an ultra-low-temperature freezer to store the vaccine?

If you do not have an ultra-low-temperature freezer available, you may use the thermal shipping container as temporary storage, if it is consistently replenished with dry ice. Please visit the Product Storage & Dry Ice section for guidelines on re-icing.

Where can I get an ultra-low-temperature freezer?

Please visit the Product Storage & Dry Ice section for a list of vendors who offer ultra-low-temperature freezers for vaccine storage.

Is there preservative in the vaccine?

No, the vaccine does not contain preservative.

How long can I store the vials in the ultra-low-temperature freezer?

Undiluted vaccine vials can be stored in an ultra-low-temperature freezer until expiration, which is 6 months from the time of manufacturing. Please check the expiration date on the vials and visit the Product Storage & Dry Ice section for guidelines on storage and handling.

How long can undiluted vials be stored in a refrigerator?

Undiluted vials may be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 120 hours (5 days) prior to dilution.

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. If you are a healthcare professional residing in the U.S. and have questions about using the Pfizer-BioNTech COVID-19 Vaccine, call 1-800-438-1985 to talk to a 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 vials to thaw?

A full tray of vials will thaw within 3 hours in the refrigerator at 2°C to 8°C (35°F to 46°F). 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.

What should I do if I cannot remove the box with the vial trays?

If you feel resistance when trying to remove the box that holds the vial trays, do not pull it out by force. Keep the box inside the thermal shipping container and remove the vial trays separately using the clear plastic straps.

Diluent

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What type of diluent should I use with the vaccine?

Dilute with sterile 0.9% Sodium Chloride Injection, USP. Do not use bacteriostatic saline.

How do I dilute the vaccine for administration?

Dilute the thawed vial of Pfizer-BioNTech COVID-19 Vaccine by adding 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP, into the vial. Do not add more than 1.8 mL of diluent. Please see the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and refer to the Dosing & 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.

How can I order more diluent?

Diluent will be included in the ancillary kits provided by CDC to its jurisdictions. The U.S. 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 .

How should the diluent be stored?

The diluent is sterile 0.9% Sodium Chloride Injection, USP, and should be stored at room temperature.

How many full doses does the vial contain?

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Do not pool excess vaccine from multiple vials
Please see the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and refer to the Dosing & 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.

Dry Ice

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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. 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 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 trays 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 re-iced every 5 days. If the thermal shipping container is opened more frequently, replenishment will need to occur more often. Please refer to the Product Storage & Dry Ice section for instructions for replenishing dry ice.

How do I refill the dry ice shipping container?

For Softbox containers: 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 trays. Reinsert the dry ice pod on top of the box that holds the vial tray. Then fill the dry ice pod to the top with dry ice (do not overfill).

For AeroSafe containers: 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 side compartments. Reinsert the dry ice pod on top of the box that holds the vial tray. Then fill the dry ice pod to the top with dry ice (do not overfill).

Where and how can I get more dry ice?

For a list of dry ice vendors, please visit the Product Storage & Dry Ice section.

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 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 re-iced every 5 days. If the thermal shipping container is opened more frequently, replenishment will need to occur more often.

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. 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 Product Storage & Dry Ice section 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.

What type of gloves should I use when transferring vial trays from the thermal shipping container to the refrigerator?

Wear waterproof insulated gloves to prevent skin contact while transferring vial trays from the thermal shipping container to the refrigerator.

Do I need to wear gloves when handling individual vials?

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

Can I return the thermal shipping container with dry ice?

No, safely discard the dry ice when the thermal shipping container is no longer needed. Review the Dry Ice Safety Data Sheet and consult your Occupational Health Department for further guidance.

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 Pfizer-BioNTech COVID-19 Vaccine and you reside in the U.S., 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 Pfizer-BioNTech COVID-19 Vaccine and you reside in the U.S., you can call 1-800-666-7248.

How can I return the thermal shipping container and temperature monitor?

To return the thermal shipping container and temperature-monitoring device, use the preprinted return shipping label included inside the container and apply over the existing shipping label. 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.

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. You can contact the carrier identified on the return label to arrange the return.

For additional assistance on returns, call +1 701-540-4039 if in the U.S.

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. Please visit the Product Storage & Dry Ice 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.

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.

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. Contact Controlant customer service at: +1 701-540-4039.

What is the NDC?

The NDC for the Pfizer-BioNTech COVID-19 Vaccine is 59267-1000-2.

What do the package and vials look like?

shipping-container-1

Softbox

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AeroSafe

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Is the vaccine only available in a multiple dose vial?

Yes. The Pfizer-BioNTech COVID-19 Vaccine is only available in multiple dose vials.

What are the weights and dimensions of the thermal shipping container?

The weights and dimensions of the Softbox Medium ULT are:
  • Empty thermal shipping container weight: 18.7 lb (8.5 kg)
  • External dimension: 15.75” x 15.75” x 22.04”
  • Available payload space: 9.65” x 9.65” x 9.49”
  • Amount of dry ice: 50.7 lb (23 kg)
  • Weight with dry ice: 69.4 lb (31.5 kg)
  • Total Weight with 1 Vial Tray: 71.9 lb (32.6 kg)
  • Dimension of 1 Vial Tray: approximately 9” x 9” x 2”
  • Total Weight with 5 Vial Trays: 80.9 lb (36.7 kg)
The weights and dimensions of the AeroSafe 47L7 are:
  • Empty thermal shipping container weight: 20.7 lb (9.4 kg)
  • External dimension: 17.5” x 17.5” x 21.5”
  • Available payload space: 9.75” x 9.75” x 9.75”
  • Amount of dry ice: 48.5 lb (22 kg)
  • Weight with dry ice: 69.2 lb (31.4 kg)
  • Total Weight with 1 Vial Tray: 71.7 lb (32.5 kg)
  • Dimension of 1 Vial Tray: approximately 9” x 9” x 2”

Where is the vaccine being manufactured?

Multiple Pfizer manufacturing locations (Puurs, Belgium and Kalamazoo, Michigan).

Ensuring Authenticity

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How can I verify if the vaccine product I receive is authentic?

  • Pfizer is committed to patient safety and ensuring that people have accurate information about the investigational Pfizer-BioNTech COVID-19 Vaccine, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate Pfizer-BioNTech COVID-19 Vaccines to protect patients from products that might be dangerous and lead to serious and life-threatening harm
  • The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older
    • The Pfizer-BioNTech COVID-19 Vaccine is only administered intramuscularly by a healthcare professional
    • The Pfizer-BioNTech COVID-19 Vaccine is not taken orally and is not available in a capsule or tablet form
  • Authentic Pfizer-BioNTech COVID-19 Vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and are dispensed in a vial with a purple cap
  • The Pfizer-BioNTech COVID-19 Vaccine is not sold online
    • The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Pfizer
If you suspect the Pfizer-BioNTech COVID-19 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.
  • Two types of thermal shipping containers are used to transport the Pfizer-BioNTech COVID-19 Vaccine: a Softbox thermal shipping container and an AeroSafe thermal shipping container. Their outer appearance is different, but their components are very similar. Both thermal shipping containers contain a dry ice pod, vial tray, box that holds the vial tray, foam lid, and an outer box housing all the components
  • The Pfizer-BioNTech COVID-19 Vaccine is contained in 2 mL type 1 glass preservative-free multiple dose vials with 0.45 mL of frozen liquid drug product
shipping-container-1

Softbox

shipping-container-2

AeroSafe

shipping-container-3

The weights and dimensions of the Softbox Medium ULT are:

  • Empty thermal shipping container weight: 18.7 lb (8.5 kg)
  • External dimension: 15.75” x 15.75” x 22.04”
  • Available payload space: 9.65” x 9.65” x 9.49”
  • Amount of dry ice: 50.7 lb (23 kg)
  • Weight with dry ice: 69.4 lb (31.5 kg)
  • Total Weight with 1 Vial Tray: 71.9 lb (32.6 kg)
  • Dimension of 1 Vial Tray: approximately 9” x 9” x 2”
  • Total Weight with 5 Vial Trays: 80.9 lb (36.7 kg)

The weights and dimensions of the AeroSafe 47L7 are:

  • Empty thermal shipping container weight: 20.7 lb (9.4 kg)
  • External dimension: 17.5” x 17.5” x 21.5”
  • Available payload space: 9.75” x 9.75” x 9.75”
  • Amount of dry ice: 48.5 lb (22 kg)
  • Weight with dry ice: 69.2 lb (31.4 kg)
  • Total Weight with 1 Vial Tray: 71.7 lb (32.5 kg)
  • Dimension of 1 Vial Tray: approximately 9” x 9” x 2”

  • Important Safety Information

    • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
    • 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

      Monitor Pfizer-BioNTech COVID-19 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/)

    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
    • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
    • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
    • Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
    • Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
    • Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
    • There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
    • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
    • Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
    • Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com

For more information

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

General Product Inquiries
Call 1-877-829-2619.

Shipment Support
US Trade Customer Service
Call 1-800-666-7248.