Updated 4/21/2022: Shelf Life Extension for Pfizer-BioNTech COVID Vaccine

Updated 4/21/2022: Shelf Life Extension for Pfizer-BioNTech COVID Vaccine

April 21st, 2022 | Archive

On April 13, 2022, the Food & Drug Administration authorized a shelf life extension for the Tris/Sucrose formulations of the Pfizer-BioNTech COVID-19 vaccines from 9 to 12 months.  These formulations are the Pfizer Pediatric vaccine (Orange cap, ages 5 to 11 year old, diluent required) and the Pfizer Adult/Adolescent Tris (Gray Cap, age 12+, no diluent). The frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F) for up to 12 months from the date of manufacture. 

**This extension does not apply to the purple cap adult/adolescent formulation (dilution required). **

How does this extension affect Tris/Sucrose vials stored in refrigerator?

Before puncture, both Pfizer Pediatric vaccine (Orange cap, ages 5 to 11 year old, diluent required) and the Pfizer Adult/Adolescent Tris (Gray Cap, age 12+, no diluent) may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 10 weeks. The 10-week refrigerated beyond use date should be recorded on the carton at the time of transfer.  If the vials have a printed manufacture date of June 2021 or later you may keep the vials in refrigerator for the full 10 weeks, not to exceed the new 12-month expiration date.

• Example:  You received Pfizer Pediatric vaccine (orange cap) on 4/1/2022 with a printed manufacture date of 9/2021 and placed them in the refrigerator on that day.  Prior to the extension the expiration date was 5/31/2022 (9 months from manufacture) and the vials would have needed to be used or discarded by 5/31/2022 since beyond use date (BUD) can never exceed expiration date.  With this extension, vials with a printed manufacture date of 9/2021 now have an updated expiration date of  8/31/2022 (12 months from manufacture).  Therefore, the vials must be used or discarded by 6/10/2022, which is 10 weeks from the date they were placed in the refrigerator.

Vaccination providers that have Tris/Sucrose formulations of the Pfizer-BioNTech COVID-19 vaccines in storage must:

1. Mark the carton and/or vials with the new expiration date as listed on the Pfizer Expiry Information webpage.
2. Update the expiration date in the NYSIIS inventory module
3. Remember to always label the 10-week BUD when moving vials to refrigerated storage.  The BUD must never exceed the expiration date found on the Pfizer Expiry Information webpage.