
5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE
(ORANGE CAP)1-4
REFRIGERATED STORAGE TIME |
DOSE |
|
AMOUNT OF DILUENT PER VIAL |
DOSES PER VIAL |
Dose preparation1
The Pfizer-BioNTech COVID-19 Vaccine is available in a 5 through 11 years of age (Orange Cap) presentation with different directions for dilution than for the two presentations (Purple Cap and DO NOT DILUTE - Gray Cap) for individuals 12 years of age and older1-3
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The 5 through 11 years, DILUTE BEFORE USE (Orange Cap) presentation contains a volume of
1.3 mL , supplied as a frozen suspension that does not contain preservative, and must be thawed and diluted prior to administration -
Vials may be thawed in the refrigerator [2°C to 8°C (35°F to 46°F)] for up to 4 hours or at room temperature [up to 25°C (77°F)] for 30 minutes
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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
1.3 mL of sterile 0.9% Sodium Chloride Injection, USP, to form the vaccine -
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 1.3 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
The 5 through 11 years, DILUTE BEFORE USE (Orange Cap) presentation vials of the vaccine contain
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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


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 Pfizer-BioNTech COVID-19 Vaccine should be used for children 5 through 11 years old because of the potential for vaccine administration errors, including dosing errors. 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 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 BioNTech and Pfizer's COVID-19 Vaccines
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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
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The vaccines are only administered intramuscularly by a healthcare professional1
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The vaccines are not taken orally and are 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 border446
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For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border15
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For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border34
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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 border23
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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 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 sale5,68,128,128,99,13
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.
- 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. -
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) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap.
Pfizer and BioNTech; August 31, 2022. - COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
- McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.