
Dilute


AGES 12 YEARS AND OLDER,
(GRAY CAP)3
REFRIGERATED STORAGE TIME |
DOSE |
AMOUNT OF DILUENT PER VIAL |
DOSES PER VIAL |

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
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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
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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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Refer to thawing instructions in the panels below
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One vial contains 6 doses of 0.3 mL
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


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

AGES 12 YEARS AND OLDER, DILUTE BEFORE USE
REFRIGERATED STORAGE TIME |
DOSE |
AMOUNT OF DILUENT PER VIAL |
DOSES PER VIAL |
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
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The contents of the vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP, to form the vaccine
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After dilution, the vial contains 6 doses of 0.3 mL of vaccine
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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
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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
-
Strict adherence to aseptic technique must be followed
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


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
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 professional2,3
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The vaccine is not taken orally and is not available in a capsule or tablet form2,3
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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 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
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For Ages 12 years and older DO NOT DILUTE Gray Cap vials, the vial label includes a gray border3
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For Ages 5 through 11 years DILUTE BEFORE USE Orange Cap vials, the vial label includes an orange border5
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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 sale6,7
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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COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; December 16, 2021.
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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.
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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.
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Data on File. Pfizer Inc. New York, NY.
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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.
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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.