Updated 4/21/2022: Shelf Life Extension for Pfizer-BioNTech COVID VaccineApril 21st, 2022 | Vaccine•COVID-19
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:
- Mark the carton and/or vials with the new expiration date as listed on the Pfizer Expiry Information webpage.
- Update the expiration date in the NYSIIS inventory module
- 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.