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Pfizer Tris Shelf Life Extension (9-12 Months) Approved

Pfizer Tris Shelf Life Extension (9-12 Months) Approved

The Food & Drug Administration has approved an amendment to the EUA for Pfizer Tris COVID-19 vaccine extending the shelf-life of the following Pfizer product formulations from 9 to 12 months:

  • Pfizer Tris Pediatric vaccine (Orange Cap for ages 5 through 11, with diluent)
  • Pfizer Adult Tris (Gray Cap for ages 12+, no diluent)

Vials stored consistently in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F) may remain in use for up to 12 months beyond the date of manufacture printed on the vials and cartons. Vials stored in refrigerated vials (2°C to 8°C) are NOT eligible for extension, regardless of the expiration date. Additional information on Pfizer storage and handling may be found at Administration Overview for Pfizer-BioNTech COVID-19 Vaccine | CDC.

Pfizer Orange and Gray Cap Tris Vaccine expiry dates based on 12 months from the date of the manufacture are shown below and at Expiry Information for Pfizer COVID-19 Vaccines.

No changes have been made to the vaccine itself to enable extension of expiry dating. This change is based on stability data submitted by the manufacturer to the FDA.

Reminders:

  • Do not use Pfizer Tris products beyond 12 months from manufacture date.
  • Expiration dates for the Pfizer TRIS products are NOT printed on the vaccine cartons or vials.
  • Do not store Pfizer vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.

For more information, please review the updated FDA Factsheets:
Fact Sheet for Healthcare Providers Administering Vaccine (Gray Cap/Adult)
Fact Sheet for Healthcare Providers Administering Vaccine (Orange Cap/PEDS)

COVID-19 vaccines authorized under an EUA do not have fixed expiration dates, and expiration dates may be extended as more stability data is collected. Always check Expiry Information for Pfizer COVID-19 Vaccines  to obtain the most up-to-date expiration dates for the Pfizer COVID-19 vaccines you have in inventory.