
6 MONTHS THROUGH
4 YEARS OF AGE,
DILUTE BEFORE USE
(MAROON CAP)1

6 MONTHS THROUGH 4 YEARS OF AGE
(MAROON CAP)1
REFRIGERATED STORAGE TIME |
DOSE |
|
AMOUNT OF DILUENT PER VIAL |
DOSES PER VIAL |
Dose preparation1
The Pfizer-BioNTech COVID-19 Vaccine is available in a 6 months through 4 years of age (Maroon Cap) presentation with different directions for dilution than for the other three presentations (Purple Cap, DO NOT DILUTE - Gray Cap, and Orange Cap)1-4
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The 6 months through 4 years, DILUTE BEFORE USE (Maroon Cap) presentation contains a volume of 0.4 mL, supplied as a frozen suspension that does not contain preservative, and must be thawed and diluted prior to administration
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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)]
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Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles
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The contents of the vial must be diluted with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP, to form the vaccine
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Sterile 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 2.2 mL of diluent
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After dilution, the vial contains 10 doses of 0.2 mL of vaccine
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After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm that there are no particulates and no discoloration is observed
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Strict adherence to aseptic technique must be followed
Administration1
Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be a white to off-white suspension. During the visual inspection,
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Verify the final dosing volume of 0.2 mL
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Confirm there are no particulates and that no discoloration is observed
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Do not administer if vaccine is discolored or contains particulate matter
Administer the vaccine intramuscularly.
Extracting 10 doses1
After dilution, the 6 months through 4 years, DILUTE BEFORE USE (Maroon Cap) presentation vials of the vaccine contain 10 doses of 0.2 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:
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Each dose must contain 0.2 mL of vaccine
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If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume
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Do not pool excess vaccine from multiple vials


Vaccination schedule1



In addition to the above
[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.]
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.
No other vaccine presentation of the
Notwithstanding the age limitations for use of the different formulations and presentations, children who will turn 5 between their doses in the primary regimen should receive their age-appropriate dose at the time of the vaccination, and the interval between doses is determined by the individual age at the start of the vaccination.
Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine and Registered Trademark Name COMIRNATY®
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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
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The vaccine is only administered intramuscularly by a healthcare professional1
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The vaccine is not taken orally and is not available in a capsule or tablet form1
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Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and are dispensed in a vial as follows:
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For 6 months through 4 years of age, DILUTE BEFORE USE, Maroon Cap vials, the vial label includes a maroon border1
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For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border4
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For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border3
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For 12 years of age and older, DILUTE BEFORE USE, Purple Cap vials. Two versions of the vial label are in current circulation - with or without a purple border2
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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 sale5,6
If you suspect the vaccine you have purchased may be counterfeit, contact us at
To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.
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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. -
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. -
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. -
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. -
COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
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McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.