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DOSING & Preparation

12 years of age and older

COMIRNATY® (COVID-19 Vaccine, mRNA): FDA APPROVED FOR INDIVIDUALS 12 YEARS OF AGE AND OLDER AS A TWO-DOSE PRIMARY SERIES1,2

In individuals 12 years of age and older, COMIRNATY® (COVID-19 Vaccine, mRNA) has been approved as a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2.


FDA AUTHORIZED FOR EMERGENCY USE3-7

Emergency uses of the vaccines 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 aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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.

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 for primary series doses 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.

gray cap Do Not
Dilute
Purple cap Dilute Before Use
Gray cap

12 YEARS OF AGE AND OLDER, DO NOT DILUTE (GRAY CAP)4

REFRIGERATED STORAGE TIME
10 Weeks

DOSE
30 mcg

AMOUNT OF DILUENT PER VIAL
NO DILUTION

DOSES PER VIAL
6 doses per vial (no dilution)


Purple Cap

If you are using vials of the vaccine with a purple cap (DILUTE BEFORE USE) presentation, DO NOT USE these instructions. Click here to see instructions for vials with a purple cap.



Dose preparation4

  • The 12 years of age and older, DO NOT DILUTE (Gray Cap) presentation of the vaccine has a gray cap and contains a volume of 2.25 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed prior to administration. Do not dilute prior to use
  • Vials may be thawed in the refrigerator [2°C to 8°C (35°F to 46°F)] or at room temperature [up to 25°C (77°F)]
  • Refer to thawing instructions in the panels below
  • One vial contains 6 doses of 0.3 mL

OPEN ALL

CLOSE ALL

Vial Verification

Verify Vial Cap Color

Verify Vial Cap Color
  • Verify that the vial has a gray plastic cap and label with gray border. If the vial has a purple plastic cap and purple label border, do not use these instructions
  • Click here to see instructions for vials with purple caps (DILUTE BEFORE USE) and refer to the Prescribing Information for that product
Thawing Prior to Use

Thawing Prior to Use

hawing Prior to Use
  • Thaw vial(s) of the vaccine before use either by:
    • Allowing vial(s) to thaw in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of 10 vials may take up to 6 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks
    • Allowing vial(s) to sit at room temperature [up to 25°C (77°F)] for 30 minutes
  • Vials may be stored at room temperature [up to 25°C (77°F)] for up to 12 hours prior to use

Invert

Invert
  • Before use, mix by inverting vaccine vial gently 10 times
  • Do not shake
  • Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles
  • After mixing, the vaccine should appear as a white to off-white suspension with no visible particles
  • Do not use if liquid is discolored or if particles are observed after mixing
Preparation of Individual 0.3 mL Doses of the Vaccine

Preparation of Individual 0.3 mL Doses of the Vaccine

Preparation of Individual 0.3 mL Doses of the Vaccine
  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the vaccine preferentially using a low dead-volume syringe and/or 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
  • Administer immediately

Record Date and Time

Record Date and Time
  • Record the date and time of first vial puncture on the vaccine vial label
  • Store between 2°C to 25°C (35°F to 77°F)
  • Discard any unused vaccine 12 hours after first puncture



Administration4

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be a white to off-white. During the visual inspection:

  • Verify the final dosing volume of 0.3 mL
  • Confirm there are no particulates and that no discoloration is observed
  • Do not administer if the vaccine is discolored or contains particulate matter

Administer the vaccine intramuscularly.



Extracting 6 doses4

12 years of age and older, DO NOT DILUTE (Gray Cap) presentation vials of the vaccine contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses 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
Extracting six doses Extracting six doses



Vaccination schedule4

Primary Series Vaccination schedule

In addition to the above EUA-authorized COVID-19 vaccination schedule, the CDC Interim Clinical Considerations include dosing considerations for the interval between the first and second primary series doses for some people 6 months through 64 years of age, as well as guidance related to vaccinating people with moderate to severe immunocompromise. Click here to learn more.

[By clicking the above link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.]


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.

Review the Product Safety Data Sheet for the vaccine. In the event of vial breakage, damage, or leakage, to prevent cuts and exposure to the vaccine, do not handle the vial with bare hands; wear protective gloves. Remove broken glass with forceps, tongs, or other appropriate tools. Dispose of the vial and vial pieces in a medical sharps container.


For children who will turn 12 between their first and second dose, see guidance from the EUA Fact Sheets, for Vaccination Providers and the CDC below.

Notwithstanding the age limitations for use of the different formulations and presentations according to the EUA Fact Sheets, children who will turn 12 between their first and second dose in the primary regimen may receive, for either dose, either:

  • the 5 through 11 years of age, DILUTE BEFORE USE (Orange Cap) presentation (each 0.2 mL dose containing 10 mcg modRNA)
  • the 12 years of age and older, DILUTE BEFORE USE (Purple Cap) presentation or 12 years of age and older, DO NOT DILUTE (Gray Cap) presentation (each 0.3 mL dose containing 30 mcg modRNA)

Regardless of whether the child received 10 mcg or 30 mcg as the first dose, the CDC states that if a child turns from 11 to 12 years of age in between their first and second dose, the second dose should be the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older. However, if the child receives the Pfizer-BioNTech COVID-19 Vaccine for children ages 5 through 11 years for their second dose, they do not need to repeat the dose.

Related pages:

Storage & Handling Dosing & Preparation Safety & Efficacy
purple cap

12 YEARS OF AGE AND OLDER, DILUTE BEFORE USE (PURPLE CAP)3

REFRIGERATED STORAGE TIME
1 month

DOSE
30 mcg

AMOUNT OF DILUENT PER VIAL
1.8 mL

DOSES PER VIAL
6 doses per vial (after dilution)



Dose preparation3

  • The 12 years of age and older, DILUTE BEFORE USE presentation of the vaccine has a purple cap and contains a volume of 0.45 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed before dilution
  • Vials may be thawed in the refrigerator [2°C to 8°C (35°F to 46°F)] or at room temperature [up to 25°C (77°F)]
  • Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles
  • The contents of the vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP, to form the vaccine
  • 0.9% Sodium Chloride Injection, USP, is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Do not add more than 1.8 mL of diluent
  • After dilution, the vial contains 6 doses of 0.3 mL of vaccine
  • After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm that there are no particulates and no discoloration is observed
  • Strict adherence to aseptic technique must be followed

OPEN ALL

CLOSE ALL

Vial Verification

Verify Vial Cap Color

Verify Vial Cap Color
  • Verify that the vial has a purple plastic cap. Some vials also may have a purple label border. If the vial has a gray plastic cap and gray label border, do not use these instructions
  • Click here to see instructions for vials with gray caps (DO NOT DILUTE) and refer to the Prescribing Information for that product
Thawing Prior to Dilution

Thaw

Thaw
  • Thaw vial(s) of the vaccine before use either by:
    • Allowing vial(s) to thaw in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month
    • Allowing vial(s) to sit at room temperature [up to 25°C (77°F)] for 30 minutes
  • Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours

Invert

Invert
  • Before dilution invert vaccine vial gently 10 times
  • Do not shake
  • Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles
  • Do not use if liquid is discolored or if other particles are observed
Dilution

Dilute

Dilute
  • Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent
  • Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle)
  • Cleanse the vaccine vial stopper with a single-use antiseptic swab
  • Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial

Equalize

Equalize
  • Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL of air into the empty diluent syringe

Invert

Invert
  • Gently invert the vial containing the vaccine 10 times to mix
  • Do not shake
  • Inspect the vaccine in the vial
  • The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter

Record and Store

Record and Store
  • Record the date and time of dilution on the vaccine vial label
  • Store between 2°C to 25°C (35°F to 77°F)
  • Discard any unused vaccine 6 hours after dilution
Withdrawal of Individual 0.3 mL Doses of the Vaccine

Cleanse and Withdraw

Cleanse and Withdraw
  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the vaccine preferentially using a low dead-volume syringe and/or needle
  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in a single vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Administer immediately


Administration3

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-white suspension. During the visual inspection:

  • Verify the final dosing volume of 0.3 mL
  • Confirm there are no particulates and that no discoloration is observed
  • Do not administer if vaccine is discolored or contains particulate matter

Administer the vaccine intramuscularly.



Extracting 6 doses3

12 years of age and older, DILUTE BEFORE USE (Purple Cap) presentation vials of the vaccine contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses 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
Extracting six doses



Vaccination schedule3

Primary Series Vaccination schedule

In addition to the above EUA-authorized COVID-19 vaccination schedule, the CDC Interim Clinical Considerations include dosing considerations for the interval between the first and second primary series doses for some people 6 months through 64 years of age, as well as guidance related to vaccinating people with moderate to severe immunocompromise. Click here to learn more.

[By clicking the above link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.]


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.

Review the Product Safety Data Sheet for the vaccine. In the event of vial breakage, damage, or leakage, to prevent cuts and exposure to the vaccine, do not handle the vial with bare hands; wear protective gloves. Remove broken glass with forceps, tongs, or other appropriate tools. Dispose of the vial and vial pieces in a medical sharps container.


For children who will turn 12 between their first and second dose, see guidance from the EUA Fact Sheet for Vaccination Providers and the CDC below.

Notwithstanding the age limitations for use of the different formulations and presentations according to the EUA Fact Sheets, children who will turn 12 between their first and second dose in the primary regimen may receive, for either dose, either:

  • the 5 through 11 years of age, DILUTE BEFORE USE (Orange Cap) presentation (each 0.2 mL dose containing 10 mcg modRNA)
  • the 12 years of age and older, DILUTE BEFORE USE (Purple Cap) presentation or 12 years of age and older, DO NOT DILUTE (Gray Cap) presentation (each 0.3 mL dose containing 30 mcg modRNA)

Regardless of whether the child received 10 mcg or 30 mcg as the first dose, the CDC states that if a child turns from 11 to 12 years of age in between their first and second dose, the second dose should be the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older. However, if the child receives the Pfizer-BioNTech COVID-19 Vaccine for children ages 5 through 11 years for their second dose, they do not need to repeat the dose.

Related pages:

Storage & Handling Dosing & Preparation Safety & Efficacy

Ensuring the Authenticity of BioNTech and Pfizer's COVID-19 Vaccines

  • Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccines, including how they are accessed and administered. We are actively monitoring for fraudulent offers of illegitimate vaccines to protect patients from products that might be dangerous and lead to serious and life-threatening harm
    • The vaccines are only administered intramuscularly by a healthcare professional3,4
    • The vaccines are not taken orally and are not available in a capsule or tablet form3,4
  • 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 border646
    • For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border55
    • For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border44
    • 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 border33
  • Ensure the safety of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use.
    To prevent counterfeits, discard vaccine vials in sharps containers and empty vial cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through government-authorized vaccination centers – such as doctor’s offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccines can only be administered by licensed healthcare professionals, or other individuals that are approved vaccinators, at government-authorized vaccination sites. Individual doses are not for sale8,98,128,128,99,13

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. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; July 8, 2022.
  2. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray 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), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; October 18, 2022.
  4. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; August 31, 2022.
  5. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; October 12, 2022.
  6. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap. Pfizer and BioNTech; August 31, 2022.
  7. Data on file. Pfizer Inc. New York, NY.
  8. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  9. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

COMIRNATY

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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COMIRNATY

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.


Important Safety Information

Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.

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 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).

Myocarditis and Pericarditis

Postmarketing data with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. 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 the vaccine.

Limitation of Effectiveness

The vaccine may not protect all vaccine recipients.

Adverse Reactions

Primary Series Adverse Events:

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%).

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 Pfizer-BioNTech COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the vaccine.

Before administration, please click to see

COMIRNATY Full Prescribing Information (Primary Series 12 years of age and older), DO NOT DILUTE, Gray Cap
COMIRNATY Full Prescribing Information (Primary Series 12 years of age and older), DILUTE BEFORE USE, Purple Cap
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Vaccination Providers (Primary Series 12 years of age and older), DO NOT DILUTE, Gray Cap
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Vaccination Providers (Primary Series 12 years of age and older), DILUTE BEFORE USE, Purple Cap
Recipients and Caregivers Fact Sheet: (Primary Series and Bivalent Booster Dose 12 years of age and older)

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Now Authorized: Effective 12/08/22

Pfizer-BioNTech COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) IS NOW AUTHORIZED FOR EMERGENCY USE AS DOSE 3 IN A THREE-DOSE PRIMARY SERIES IN ELIGIBLE INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE

Click to view the EUA Fact Sheet for Vaccination Providers, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

Emergency Use Authorization

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 aged 6 months and older as appropriate. 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. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

Changes include but are not limited to the following sections:

New Language in Teal

1 Authorized Use

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

This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent, supplied in multiple dose vials with maroon caps and labels with maroon borders, which are authorized for use in individuals 6 months through 4 years of age.

2.3 Vaccination Schedule

The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution are administered intramuscularly as a 3-dose (0.2 mL each) primary series as follows:
Dose 1: Pfizer-BioNTech COVID-19 Vaccine
Dose 2: Pfizer-BioNTech COVID-19 Vaccine
Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Dose 1 and Dose 2 (Pfizer-BioNTech COVID-19 Vaccine) are administered 3 weeks apart. Dose 3 (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) is administered at least 8 weeks after the Dose 2.

Individuals who will turn from 4 years to 5 years of age between any doses in the primary series may receive either:

  • a 3-dose primary series comprised of Pfizer-BioNTech COVID-19 Vaccine (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Doses 1 and 2 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Dose 3, or
  • a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use for individuals 5 through 11 years of age (supplied in multiple dose vials with orange caps and labels with orange borders).

6 OVERALL SAFETY SUMMARY

. . .

The safety of Pfizer-BioNTech COVID-19 Vaccine for the first and second dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months through 4 years of age,
  • safety data from clinical studies which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 5 years of age and older, and
  • postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine.

The safety of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for the third dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated a booster dose with 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) in individuals greater than 55 years of age,
    • The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
  • safety data from clinical studies which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older and
  • safety data from clinical studies which evaluated booster vaccination with Pfizer-BioNTech COVID-19 Vaccine (previously, but no longer, authorized) in individuals 5 years of age and older, and
  • postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

In a clinical study (Study 3) in participants 6 through 23 months of age who received Pfizer-BioNTech COVID-19 Vaccine containing 3 mcg of a nucleoside-modified messenger RNA encoding the spike (S) glycoprotein of SARS-CoV-2 (3 mcg nucleoside modified messenger RNA (modRNA)), 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 (Study 3) in participants 2 through 4 years of age who received Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA), 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%).

The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. The bivalent vaccine (Original and Omicron BA.1) contained 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineage BA.1, for a total of 30 mcg modRNA per dose. 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%).

Expiry Update: Effective 12/08/22

Expiry dates included in product labeling for maroon cap, orange cap, and gray cap presentations of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) have been updated from 12 to 18 months after the date of manufacture printed on the vials and cartons.

Verify the vials (including labels) prior to preparation and administration to help avoid dosing errors. Check gray cap, orange cap, and maroon cap vial labels to ensure that the name on the vial states “Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).” Please see the Formulation/Presentation Guide for more details.

Formulation/
Presentation Guide
Expiry Information

Regardless of storage condition, the maroon cap, orange cap, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vials and cartons.

I acknowledge that this website is being updated on an ongoing basis. I have read the Important Safety Information below. I will check back for further updates.

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