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Pfizer “Tris Product” Shelf-Life Extension

Pfizer “Tris Product” Shelf-Life Extension

FDA has approved a shelf-life extension for the Pfizer Pediatric vaccine (orange cap, 5-11 years old, diluent required) and the soon-to-be available Adol/Adult Tris (gray cap, age 12+, no diluent). The expiration date for Pfizer orange and gray cap vaccine has now been extended to 9 months (while held at ULT, or ultra-low temperatures). This approval takes effect immediately. This extension applies to frozen, ultra-low temperature (ULT) inventories only.

Details about this extension may be found in the updated facts sheets, accessible here: Healthcare Providers for 5-11 years of age, orange cap (must dilute); Healthcare Providers for 12 years of age and older, gray cap (no dilution). 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.”

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. The updated expiry dates for both the orange and gray cap vials based on 9 months from the date of manufacture are provided below.

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 Pediatric vaccine (orange cap, 5-11 years old, diluent required):
• 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.

Adol/Adult Tris (gray cap, age 12+, no diluent) 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 using the following links:

Pfizer-BioNTech Fact Sheets (English) and FAQs

Provider Fact Sheet: 5-11 years of age, orange cap (must dilute)

Provider Fact Sheet: 12 years of age and older, gray cap (no dilution)