CDC Phizer-BioNTech Shelf Life Extension
CDC has provided additional guidance related to the Pfizer vaccine expiration date extension as outlined below:
https://www.gpha.org/wp-content/uploads/Pfizer-Extension-Update.pdf
Pfizer-BioNTech Shelf-Life Extension
- FDA has approved the extension of Pfizer expiration dates from six to nine months immediately (no changes to vaccine – based on stability data).
- Eligible Products: Cartons/vials with expiry dates August 2021 – February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as authorized storage conditions between -90°C to -60°C have been maintained (extension also applies to expired product <9 months old that has been kept in ultra-cold storage).
- Not Eligible for the 3-month expiration date extension: Frozen vials stored at -25°C to -15°C; refrigerated vials (however, vials stored at frozen or refrigerated temperatures with a Beyond Use Date (BUD) that extends past 8/31/2021 may be honored. Please do not waste or discard these doses until the BUD has passed).
Updated Expiry Dates – Reference Table
BUD Case Scenarios:
Pfizer-BioNTech COVID-19 Vaccine Expiration Extension
With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been several questions about how this might impact beyond-use dates. Below are a few case scenarios you might encounter.
To prevent vaccine from inadvertently being discarded, providers should ensure the new expiration date is indicated, i.e., label the tray or post on the unit.
Case scenario #1:
You move a vial of Pfizer vaccine from freezer storage to the refrigerator on August 15. It is marked with the expiration date of August 2021 (August 31, 2021). Can you store this vaccine for the full 31 days allowed for refrigeration storage, or do you need to administer it by August 31, 2021?
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- Yes, you can store this vaccine vial for the full 31 days (i.e., through September 15, 2021). The recent expiration date extension changes the expiration date to November 2021. The BUD replaces the manufacturer’s expiration date (now November/2021) and should be noted on the label along with the initials of the person making the calculation.
Case scenario #2:
You move a vial of Pfizer vaccine from ultracold storage to the freezer on August 23. It is marked with the expiration date of August 2021 (August 31, 2021). Can you store this vaccine for the full 2 weeks allowed in the freezer? After that time, can you still move it to the refrigerator and store for an additional 31 days?
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- Yes, you can store this vaccine vial for the full 2 weeks in the freezer (through September 6, 2021), move it to the refrigerator, and store for an additional 31 days (October 7, 2021). The recent expiration date extension changes the expiration date to November 2021. The BUD replaces the manufacturer’s expiration date (now November 2021) and should be noted on the label along with the initials of the person making the calculation.
Case scenario #3:
You move a vial of Pfizer-BioNTech COVID-19 vaccine from the freezer to the refrigerator on August 1, 2021. Since the expiration date has been extended, can you store this vial in the refrigerator through November 31, 2021?
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- No, you cannot store this vial through the extended expiration date. A vial can be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month (31 days) regardless of the expiration date extension.
Clinical guidance and resources for storing, preparing and administering the vaccine, including labels to assist with tracking the BUD can be found here: www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
