Risk Info|Dosing & Prep|Pfizer-BioNTech COVID-19 Vaccine For 5 Through 11 Years Of Age|Official HCP Site

DOSING & PREPARATION

5 through 11 years of age,
DILUTE BEFORE USE
(Orange 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.

5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE

(ORANGE CAP)^1-4

REFRIGERATED STORAGE TIME 10 weeks	DOSE 10 mcg
AMOUNT OF DILUENT PER VIAL 1.3 mL	DOSES PER VIAL 10 doses per vial (after dilution)

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 older^1-3

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
Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles
The contents of the vial must be diluted with 1.3 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
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 an orange plastic cap and a label with an orange border and states “Age 5y to < 12y”

Thawing Prior to Dilution

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 4 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 1.3 mL of diluent into a transfer syringe (21‑gauge or narrower needle)
Cleanse the vaccine vial stopper with a single‑use antiseptic swab
Add 1.3 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 1.3 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

The 5 through 11 years, DILUTE BEFORE USE (Orange 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

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

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
- The vaccines are only administered intramuscularly by a healthcare professional¹
- The vaccines are not taken orally and are 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 border⁴⁴⁶
- For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border¹⁵
- For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border³⁴
- 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
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 sale^5,6^8,12^8,12^8,9^9,13

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) (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.

Dose preparation¹