DOSING & PREPARATION

6 months through
4 years of age,
DILUTE BEFORE USE
(Maroon Cap)

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.

6 MONTHS THROUGH
4 YEARS OF AGE,
DILUTE BEFORE USE

(MAROON CAP)¹

6 MONTHS THROUGH 4 YEARS OF AGE DILUTE BEFORE USE

(MAROON CAP)¹

REFRIGERATED STORAGE TIME 10 weeks	DOSE 3 mcg
AMOUNT OF DILUENT PER VIAL 2.2 mL	DOSES PER VIAL 10 doses per vial (after dilution)

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

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
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 2.2 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 2.2 mL of diluent
After dilution, the vial contains 10 doses of 0.2 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

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Vial Verification

Verify Vial Cap Color

Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a maroon plastic cap and a label with a maroon border

IMPORTANT MAROON CAP VIAL INFORMATION:

The vial labels may state “Age 2y to < 5y” or “Age 6m to < 5y” and carton labels may state “For age 2 years to < 5 years” or “For age 6 months to < 5 years”. Vials with either printed age range can be used for individuals 6 months through 4 years of age.

Thawing Prior to Administration

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 10 vials may take up to 2 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 12 hours prior to use

Invert

Before dilution, mix by inverting 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 opaque amorphous particles
Do not use if liquid is discolored or if other particles are observed

Dilution

Dilute

Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent
Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (21‑gauge or narrower needle)
Cleanse the vaccine vial stopper with a single‑use antiseptic swab
Add 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial

Equalize

Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe

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 a white to off-white suspension. Do not use if vaccine is discolored or contains particulate matter

Record and Store

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

Withdrawal of Individual 0.2 mL Doses

Preparation

Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of the Pfizer-BioNTech
COVID-19 Vaccine preferentially using a low dead-volume syringe and/or needle
Each dose must contain 0.2 mL of vaccine
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
Administer immediately

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,

Verify the final dosing volume of 0.2 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 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:

Each dose must contain 0.2 mL of vaccine
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
Do not pool excess vaccine from multiple vials

Vaccination schedule¹

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.]

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 6 months through 4 years old because of the potential for vaccine administration errors, including dosing errors. For children who will turn 5 between their doses in the primary regimen, see guidance from the EUA Fact Sheet for Vaccination Providers.

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®

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 professional¹
- The vaccine is not taken orally and is not available in a capsule or tablet form¹

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 border¹
- For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border⁴
- For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border³
- 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
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 sale^5,6

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

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.
McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

Dose preparation¹