Full Prescribing Information & EUA Fact Sheets

FDA EUA Letter (12 Years & Up) Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers - 12 Years & Up EUA Fact Sheet for Recipients and Caregivers - 12 Years & Up

Questions and Answers About Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY® (COVID-19 Vaccine, mRNA)*

Approval Status

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What is COMIRNATY®?

COMIRNATY® is the brand name for an FDA-approved vaccine, indicated in individuals 16 years of age and older, to prevent COVID‑19 caused by SARS‑CoV‑2. When a medical product receives FDA approval, a brand name for the product is also approved by the FDA.3

What does FDA approval mean?

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.4

What is the difference between FDA approval and an EUA?

The EUA process is different from the FDA approval process. Under an EUA and in the midst of an emergency, the FDA can make a product available for public use based on the best available evidence, without having all the evidence that would be needed for FDA approval or clearance.4

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.4

For which age groups has the vaccine received FDA approval?

The vaccine is FDA approved in individuals 16 years of age and older.1

Individuals 12-15 years of age are eligible to receive the vaccine under an Emergency Use Authorization.2

In the clinical trial, what was the efficacy & safety of the vaccine?

In individuals 16 years of age and older1

Please see the full Prescribing Information to see the clinical trial design and efficacy (Section 14 - pg. 15) and safety (Section 6 - pg. 6).1

In individuals 12 through 15 years of age2

Please see the EUA Fact Sheet for Vaccination Providers to see the clinical trial design and efficacy (Section 18 - pg. 34) and safety (Section 6 - pg. 21).2

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.5

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 and COMIRNATY® is 91300. The administrative code is 0001A for the first dose, and 0002A for the second dose.

According to the Emergency Use Authorization Fact Sheet for Vaccination Providers, a third dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) or COMIRNATY® administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 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.2 The CPT code for this dose is 91300, and the administrative code is 0003A.

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.6

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 6 doses from the multiple dose vials. For further information, please reach out to your state, local, or tribal health department, or the CDC.5

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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What type of diluent should I use with the vaccine?

Dilute with sterile 0.9% Sodium Chloride Injection, USP. Do not use bacteriostatic saline.1

How do I dilute the vaccine for administration?

Dilute the thawed 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.1 Please see the full Prescribing Information 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.5

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 .5

How many full doses does the vial contain?

After dilution, vials of the 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 needle1:
  • 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.

Does the number of doses extracted from the vial change how much diluent is required?

No. Always use 1.8 mL of sterile 0.9% Sodium Chloride Injection as the diluent irrespective of the number of doses you are ultimately able to extract from the vial.1

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

Administration

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Please see the full Prescribing Information for 16 Years & Up and EUA Fact Sheet for Vaccination Providers for 12 Years & Up for dosage, preparation, and administration.

What is the dosing schedule for the vaccine?

The vaccine is given as a series of 2 doses 3 weeks apart.1 Please see the Dosing & Administration section for instructions on preparation, administration, and adverse event reporting requirements, as well as Safety Information for the vaccine.

According to the Emergency Use Authorization Fact Sheet for Vaccination Providers, a third dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 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.2

Can immunocompromised patients receive a third dose?

According to the Emergency Use Authorization Fact Sheet for Vaccination Providers, a third dose of the vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 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.2

Are the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY® interchangeable with other COVID-19 vaccines?

There are no data available on the interchangeability of this vaccine with other COVID-19 vaccines to complete the vaccination series.1

What if the second dose cannot be provided at 3 weeks (21 days)?

Per the full Prescribing Information and EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), the second dose of the vaccine should be given 3 weeks after the first dose.1,2

For more information, refer to the CDC Interim Clinical Considerations for authorized mRNA vaccines.

Does the vaccine contain live virus?

No, the vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.7

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.8

How many doses are in each diluted vial?

After dilution, vials of vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume (LDV) 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 needle1,2:
  • 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 vaccine contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each 0.3 mL dose of the vaccine 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.1

Can I give this vaccine at the same time as other vaccines?

According to the Emergency Use Authorization Fact Sheet for Vaccination Providers, there is no information on the co-administration of this vaccine with other vaccines.2

Also see the CDC's Summary Document for Interim Clinical Considerations for use of COVID-19 Vaccines Currently Authorized in the United States.

How do I prepare the dose?

Please see the Dosing & Administration section of this website 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. Please see the Dosing & Administration section for instructions on vaccine preparation.8

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 a sixth dose from a single vial. If a low dead-volume syringe is not available, a standard 1 mL syringe may be used.1,2,8 Please see the Dosing & Administration section for instructions on vaccine administration.

Storage and Stability

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Can I still use the product if it has become frozen after it is originally thawed?1

No, you should not use the vaccine if it has become frozen after thawing.1 The vaccine must then be discarded in a sharps container.8 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 vials in the thermal shipping container?

With proper dry ice replenishment, the thermal shipping container may be used as temporary storage for the 195-pack cartons for up to 30 days from delivery.8

The thermal shipping container included with the 25-pack cartons should be returned within 10 days of delivery and should not be used as temporary storage.8

How is the vaccine stored?

The vaccine is provided in either 25-pack or 195-pack cartons. The thermal shipping container included with the 25-pack cartons should be returned within 10 days of delivery and should not be used as temporary storage.8

Vials must be kept protected from light until ready to use.1

*Refer to the dry ice replenishment guidelines packed in the original thermal shipping container for instructions regarding the use of the thermal shipping container for temporary storage.

If you have lots that will expire shortly, please click here for more information.

At what temperature does the vaccine need to be stored?

The vaccine is provided in either 25-pack or 195-pack cartons. The thermal shipping container included with the 25-pack cartons should be returned within 10 days of delivery and should not be used as temporary storage.8

Vials must be kept protected from light until ready to use.1

*Refer to the dry ice replenishment guidelines packed in the original thermal shipping container for instructions regarding the use of the thermal shipping container for temporary storage.

If you have lots that will expire shortly, please click here 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

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.8 Please check the expiration date on the vials and, if you have lots that will expire shortly, please click here for more information.

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 1 month prior to dilution.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 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?

In the refrigerator at 2°C to 8°C (35°F to 46°F)1:
  • 25-pack cartons will take up to 2 hours to thaw
  • 195-pack cartons will take up to 3 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.1

Are components of the vaccine vial made with latex?

The vial stoppers are not made with natural rubber latex.1

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.8 Please refer to the CDC’s Vaccine Storage and Handling Toolkit for guidance on storage and handling of vaccines at https://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 for the 195-pack cartons, 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.8 Please refer to the Product Storage & Dry Ice section for instructions for replenishing dry ice.

The thermal shipping container included with the 25-pack cartons should be returned within 10 days of delivery and should not be used as temporary storage.8

How do I refill the thermal 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 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).8

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 cartons. Then fill the dry ice pod to the top with dry ice (do not overfill).8

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.

*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 thermal shipping container may be used as temporary storage for the 195-pack cartons 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.8

The thermal shipping container included with the 25-pack cartons should be returned within 10 days of delivery and should not be used as temporary storage.8

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.8 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.8

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.8 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 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 to the refrigerator?

Wear waterproof insulated gloves to prevent skin contact while transferring vial cartons from the thermal shipping container to the refrigerator.8

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.8

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.8

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

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.8 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.8

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.8

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.8 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 is the NDC?

According to the EUA Fact Sheet for Vaccination Providers, the NDC for Pfizer-BioNTech COVID-19 Vaccine labeled vials is 59267-1000-3 for 25-pack cartons and 59267-1000-2 for 195-pack cartons.2

What do the package and vials look like?

For 195-pack cartons8:

Softbox

AeroSafe

For 25-pack cartons8:

Softbox

AeroSafe

Is the vaccine only available in a multiple dose vial?

Yes, the vaccine is only available in multiple dose vials.1

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

  • External Dimensions of the Aerosafe 47L7: 17.5” x 17.5” x 21.5”8
  • External Dimensions of Softbox Medium ULT: 15.75” x 15.75” x 22.04”8
  • Dimension of one 25-pack carton: approximately 3.26” x 3.26” x 1.54”8
  • Dimension of one 195-pack carton: approximately 9” x 9” x 2”8
  • Weight range for both thermal shipping containers: approximately 64 lb to 80 lb (29 kg to 36 kg)8

Where is the vaccine being manufactured?

Multiple Pfizer manufacturing locations (Puurs, Belgium and Kalamazoo, Michigan).8

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 with a purple cap. Two versions of the vial label are in current cirulation - with or without a purple border8
  • 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 sale5,9
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.
  • Two types of thermal shipping containers are used to transport the 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 cartons, box that holds the vial cartons, foam lid, and an outer box housing all the components8
  • The vaccine is contained in 2 mL type 1 glass preservative-free multiple dose vials with 0.45 mL of frozen liquid drug product8

For 195-pack cartons8:

Softbox

AeroSafe

For 25-pack cartons8:

Softbox

AeroSafe

  • External Dimensions of the Aerosafe 47L7: 17.5” x 17.5” x 21.5”8
  • External Dimensions of Softbox Medium ULT: 15.75” x 15.75” x 22.04”8
  • Dimension of one 25-pack carton: approximately 3.26” x 3.26” x 1.54”8
  • Dimension of one 195-pack carton: approximately 9” x 9” x 2”8
  • Weight range for both thermal shipping containers: approximately 64 lb to 80 lb (29 kg to 36 kg)8

  • Important Safety Information

    Indication & Authorized Use

    Important Safety Information

    • Known history of a severe allergic reaction (eg, anaphylaxis) to any component of COMIRNATY® is a contraindication.
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

      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).

    • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
    • Syncope (fainting) may occur in association with administration of injectable vaccines, including this vaccine. Procedures should be in place to avoid injury from fainting.
    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
    • The vaccine may not protect all vaccine recipients.
    • In clinical studies 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 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%).
    • In a clinical study evaluating administration of a booster dose in participants 18 through 55 years of age, the most commonly reported adverse reactions (≥10%) following the dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%).
    • In a clinical study of adolescents 12 through 15 years of age, the most commonly reported adverse reactions included 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%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).
    • Before administration of the vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).
    • Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://vaers.hhs.gov/reportevent.html or call 1-800-822-7967.

    Indication & Authorized Use

    The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.


    Indication

    COMIRNATY® 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 16 years of age and older.

    Authorized Use

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

    • a two-dose primary series in individuals 12 through 15 years
    • a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose in individuals:
      • 65 years of age and older
      • 18 through 64 years of age at high risk of severe COVID-19
      • 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

    The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 12 years of age and older to provide:

    • a two-dose primary series in individuals 12 years of age and older
    • a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose in individuals:
      • 65 years of age and older
      • 18 through 64 years of age at high risk of severe COVID-19
      • 18 through 64 years of age at risk of serious complications of COVID-19 in the setting of frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19
References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; 2021.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Pfizer and BioNTech; 2021.
  3. Proprietary name review for biologic products. US Food & Drug Administration. Accessed August 11, 2021. https://www.fda.gov/vaccines-blood-biologics/labeling-cber-regulated-products/proprietary-name-review-biologic-products
  4. Understanding the regulatory terminology of potential preventions and treatments for COVID-19. US Food & Drug Administration. Accessed August 11, 2021. https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19
  5. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  6. 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
  7. 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
  8. Data on File. Pfizer Inc. New York, NY.
  9. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

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