For Individuals 6 Months
Through 4 Years of Age1
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
Refrigerated Storage Time:
10 Weeks
Dilution:
DILUTE BEFORE USE
Dose:
3 mcg
Dose per vial:
3 doses (after dilution)
Dose volume:
0.3 mL
For Individuals 5
Through 11 Years of Age1
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
Refrigerated Storage Time:
10 Weeks
Dilution:
DO NOT DILUTE
Dose:
10 mcg
Dose per vial:
Single dose
Dose volume:
0.3 mL
Dose Preparation & Administration1
Step 1: Verify Vials
Pfizer-BioNTech COVID-19 Vaccine
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
There are 2 presentations of
6 months through 4 years of age
DILUTE BEFORE USE
- Multiple dose vials for individuals 6 months through 4 years of age have yellow caps and labels with yellow borders
- Yellow cap vials are supplied in a carton of 10 multiple dose vials
- Each multiple dose vial contains 3 doses of 0.3 mL per dose (after dilution)
5 through 11 years of age
DO NOT DILUTE
- Single dose vials for individuals 5 through 11 years of age have blue caps and labels with blue borders
- Blue cap vials are supplied in a carton of 10 single dose vials
- Each single dose vial contains 1 dose of 0.3 mL (no dilution required)
Step 2: Thaw Vials (If Frozen)
If vials are frozen, they must be thawed prior to use. Vials can be thawed in one of two ways:
Thaw in the refrigerator
at 2°C to 8°C (35°F to 46°F)
May take up to 2 hours to thaw at this temperature.
Thaw at room temperature for 30 minutes
up to 25°C (77°F)
Verify that product has not expired. When stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF), yellow and blue cap vials should be used within 18 months. When stored in a refrigerator, yellow and blue cap vials should be used within 10 weeks from thaw. Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials and cartons.
Thawed vials can be stored in the refrigerator [2°C to 8°C (35°F to 46°F)] for up to 10 weeks* and at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After dilution, multiple dose vials should be held between 2°C to 25°C (35°F to 77°F) and discarded after 12 hours.
Do not refreeze thawed vials.
*The 10-week refrigerated expiry date should be recorded on the carton and should not exceed the expiration date printed on the vial and cartons.
Step 3: Preparation
Check the contents of the vaccine during preparation and right before use. The liquid should be clear to slightly opalescent with no visible particles. Do not use if liquid is discolored or if other particles are observed.
DILUTE BEFORE USE
6 months through 4 years of age
DILUTE BEFORE USE
- Add 1.1 mL sterile 0.9% Sodium Chloride Injection, USP into vaccine vial
- Before removing needle from vial, equalize vial pressure by withdrawing air into empty diluent syringe
- After dilution, mix by inverting thawed vial gently 10 times. Never shake the vials or vaccine
- Record date and time of dilution on vial label
- After dilution, multiple dose vials contain 3 doses of 0.3 mL each
- Store at 2°C to 25°C (35°F to 77°F) and discard after 12 hours
NOTE: If amount of vaccine in vial cannot provide a full dose of 0.3 mL, discard vial and any excess volume. Do not pool excess vaccine from multiple vials.
5 through 11 years of age
DO NOT DILUTE
- Prior to use, mix by inverting thawed vial gently 10 times. Never shake the vials or vaccine
- Withdraw a single 0.3 mL dose
- Discard single dose vial and any excess volume
Step 4: Administration
- Visually inspect for particulate matter and discoloration prior to administration
- Vaccine should be clear to slightly opalescent suspension
- DO NOT ADMINISTER if vaccine is discolored or contains particulate matter
Administer a single 0.3 mL dose intramuscularly.
Storage & Handling Resources
Ensuring the Authenticity of
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
- 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 can be visually verified via this page.
- The vaccines are not available for private purchase. The vaccines are NOT sold online and any sales over the Internet, including from online pharmacies, are not legitimate.
- The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Pfizer.
If you suspect the vaccine you have purchased may be counterfeit, contact us
at
To learn more, visit
https://www.pfizer.com/products/medicine-safety/counterfeiting.
*The 10-week refrigerated expiry date should be recorded on the carton and should not exceed the expiration date printed on the vial and cartons.
Reference
Ordering available through Pfizer Prime*
Orders for 2024-2025 formula COVID-19 vaccines by BioNTech and Pfizer can be placed by eligible
healthcare professionals directly with Pfizer through Pfizer Prime online or by calling
*Eligible healthcare providers can order COVID-19 vaccines directly from
Pfizer. If preferred, orders may be placed with your facility’s wholesaler.
