Pfizer "Tris Product" Shelf-Life Extension - ULTRA-COLD inventory ONLY
Maine Department of Health & Human Services sent this bulletin at 12/20/2021 03:24 PM ESTHaving trouble viewing this email? View it as a Web page.
Pfizer "Tris Product" Shelf-Life Extension
ULTRA-COLD INVENTORY ONLY
December 20, 2021
FDA has approved a shelf-life extension for the Pfizer Pediatric vaccine (Orange cap, 5-11 year old, diluent required) and the soon to be available Adol/Adult Tris (Gray Cap, age 12+, no diluent). This approval may be found at Healthcare Providers for 5-11 years of age, orange cap (must dilute) (fda.gov) ; Healthcare Providers for 12 years of age and older, gray cap (no dilution) (fda.gov) ) and takes effect immediately.
This extension applies to ULTRA-COLD inventories only.
As you are aware, the date printed on the Pfizer Pediatric (orange cap) and Adult/Adolescent (gray cap, 12+, no diluent) vaccine vials indicate the manufacture date and NOT the expiration date. Originally, the expiration date was 6 months from the manufacture date. The expiration date for Pfizer orange and gray cap vaccine has now been extended to 9 months (while held at ULTRA-COLD frozen.) The Fact Sheets for both orange and gray cap vials provided by the FDA now reads, “regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons”. The updated expiry dates for both the orange and gray cap vials based on 9 months from the date of manufacture are provided below.
Printed Manufacturing Date |
9-Month Expiry Date* |
06/2021 |
Feb. 28, 2022 |
07/2021 |
Mar. 31, 2022 |
08/2021 |
Apr. 30, 2022 |
09/2021 |
May 31, 2022 |
10/2021 |
Jun. 30, 2022 |
11/2021 |
July. 31, 2022 |
12/2021 |
Aug. 31, 2022 |
01/2022 |
Sept. 30, 2022 |
02/2022 |
Oct. 31, 2022 |
*Date of expiration always falls on the last day of the month
The QR code provided on the Pfizer Pediatric Vaccine carton provides a link to the EUA but does not provide information on expiration dates.
Please follow EUA recommendations for storage:
Pfizer 5 through 11 years of age formulation -
- If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
- Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to dilution.
- After dilution, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution.
Pfizer 12 years and older formulation -
- Frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed they should not be refrozen.
- Vials may be transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.
Regardless of storage condition, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons.
All Pfizer updated Fact Sheets may be found at:
- https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#additional
- Healthcare Providers for 5-11 years of age, orange cap (must dilute) (fda.gov)
- Healthcare Providers for 12 years of age and older, gray cap (no dilution) (fda.gov)