The Food and Drug Administration (FDA) has approved a shelf-life extension for the Pfizer Pediatric vaccine (orange cap, 5-11 years of age, diluent required) and the soon to be available Adol/Adult Tris (gray cap, age 12 years of age and older, 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-low temperature (ULT) frozen inventories only.
As you are aware, the date printed on the Pfizer Pediatric (orange cap) and Adult/Adolescent (gray cap) vaccine vials indicate the manufacture date and NOT the expiration date. Originally, the expiration date was six months from the manufacture date. The expiration date for Pfizer orange and gray cap vaccine has now been extended to nine months (while held at ULT frozen.) The Fact Sheets for both orange and gray cap vials provided by the FDA now read, “regardless of storage conditions, vaccines should not be used after nine 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 nine months from the date of manufacture are provided below.
*Date of expiration always falls on the last day of the month.
All Pfizer updated Fact Sheets 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)