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DOSING & Preparation

Ages 12 years and older

FDA APPROVED FOR INDIVIDUALS ≥16 YEARS OF AGE - TWO DOSE PRIMARY SERIES1

In individuals 16 years of age and older, COMIRNATY® (COVID-19 Vaccine, mRNA)* has been approved for active immunization to prevent COVID-19 caused by SARS-CoV-2.1 COMIRNATY® (COVID-19 Vaccine, mRNA) is also known as the Pfizer-BioNTech COVID-19 Vaccine.2


FDA AUTHORIZED FOR EMERGENCY USE2,3

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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

AGES 12 YEARS AND OLDER, DO NOT DILUTE
(GRAY CAP)3

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 preparation3

  • The Ages 12 years 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

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Administration3

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 doses3

Ages 12 years 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



Dosing schedule3

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When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns, but should not be used for individuals 5 through 11 years of age, because of the potential for vaccine administration errors, including dosing errors.

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, 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 Ages 12 years and older, DILUTE BEFORE USE (Purple Cap) presentation or Ages 12 years 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.

purple cap

AGES 12 YEARS AND OLDER, DILUTE BEFORE USE
(PURPLE CAP)2

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 preparation2

  • The Ages 12 years 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
  • After dilution, the vial contains 6 doses of 0.3 mL of 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 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

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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


Administration2

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 doses2

Ages 12 years 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



Dosing schedule2

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Primary Series
Primary Series Primary Series

For immunocompromised individuals with certain conditions:

A third dose of the vaccine 30 mcg (0.3 mL) administered at least 28 days following the second dose 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.

Booster Dose

For those who have completed primary vaccination with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)

The vaccine is administered as a single booster dose at least 5 months after completing the primary series to individuals:

12 YEARS OF AGE AND OLDER

30 mcg (0.3 mL)

Intramuscular Injection

For additional information related to administration of a booster dose in immunocompromised individuals, see CDC interim clinical considerations.


For those who have completed primary vaccination with another authorized or approved COVID-19 vaccine

A single booster dose may be administered to those who have completed primary vaccination with another authorized or approved COVID-19 vaccine.


The dosing interval for the heterologous booster dose is the same as that authorized or approved for a booster dose of the vaccine used for primary vaccination.

18 YEARS OF AGE AND OLDER

30 mcg (0.3 mL)

Intramuscular Injection



When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns, but should not be used for individuals 5 through 11 years of age, because of the potential for vaccine administration errors, including dosing errors.

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, 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 Ages 12 years and older, DILUTE BEFORE USE (Purple Cap) presentation or Ages 12 years 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.

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 professional2,3
    • The vaccine is not taken orally and is not available in a capsule or tablet form2,3
  • 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 Ages 12 years and older DILUTE BEFORE USE Purple Cap vials. Two versions of the vial label are in current circulation - with or without a purple border2
    • For Ages 12 years and older DO NOT DILUTE Gray Cap vials, the vial label includes a gray border3
    • For Ages 5 through 11 years DILUTE BEFORE USE Orange Cap vials, the vial label includes an orange border5
  • Ensure the safety of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use. To prevent counterfeits, discard vaccine vials in sharps containers and empty vial cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through government-authorized vaccination centers – such as doctor’s offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccine can only be administered by licensed healthcare professionals, or other individuals that are approved vaccinators, at government-authorized vaccination sites. Individual doses are not for sale6,7

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. Pfizer and BioNTech; December 16, 2021.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; January 31, 2022.
  3. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; January 31, 2022.
  4. Data on File. Pfizer Inc. New York, NY.
  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; January 03, 2022.
  6. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  7. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

Indication & Authorized Use

Authorized Use & Indication

Important Safety Information

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Indication & Authorized Use

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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.

Interchangeability

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap), when prepared according to their respective instructions for use, can be used interchangeably. COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older (purple cap and gray cap) should not be used for individuals 5 through 11 years of age, because of the potential for vaccine administration errors, including dosing errors.

Authorized Use

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

  • a 2-dose 30 mcg modRNA primary series to individuals 12 through 15 years of age
  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older to provide:

  • a 2-dose 10 mcg modRNA primary series to individuals 5 through 11 years of age
  • a 2-dose 30 mcg modRNA primary series to individuals 12 years of age and older
  • a third 10 mcg modRNA primary series dose to individuals 5 through 11 years of age who have been determined to have certain kinds of immunocompromise
  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine



Important Safety Information

Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the 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 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. The observed risk is higher among 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 (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. 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.

Primary Series Adverse Events:
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%).

In a clinical study (30 mcg modRNA) of adolescents 12 through 15 years of age, adverse reactions following the administration of the primary series 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%).

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

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

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