Comirnaty/Pfizer-BioNTech COVID-19 Vaccine
Shelf Life Extension
The U.S. Food & Drug Administration (FDA) has authorized a shelf life extension for the Comirnaty/Pfizer-BioNTech COVID-19 vaccine to 9 months when stored in ultra-low temperature freezers.
Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as authorized storage conditions between -90.0°C to -60.0°C (-130.0°F to -76.0°F) have been maintained. Frozen vials stored at -25.0°C to -15.0°C and refrigerated vials (2.0°C to 8.0°C) are NOT eligible for extension.
The extended expiration date is effective immediately for all currently available batches that have not yet expired. NOTE: Expiration dates extension does NOT apply to vials dated July 2021 and earlier. No changes have been made to the vaccine itself to enable extension of expiry dating. This change is based on stability data generated on batches manufactured over approximately the past nine months of COVID-19 vaccine development, from the batches that supplied early clinical trials through the commercial scale batches currently in production. Currently available vaccine will not have an updated NDC.
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Comirnaty/Pfizer-BioNTech Storage and Handling Requirements
- Ultra-low-temp freezer (-60.0⁰C and -90.0⁰C)
- Printed expiration date through July 2021
- Expiration date is what is printed on tray/vial
- Printed expiration date Aug 2021 - Feb 2022
- Expiration date extended 3 months beyond printed date
- Providers can check for updated expiration dates for their Comirnaty/Pfizer-BioNTech vaccine on page 3 of the EUA Fact Sheet
- Freezer up to 2 weeks (-15.0°C and -25.0°C)
- Refrigerator up to 30 days (2.0°C and 8.0°C)
- Total storage time for Pfizer in freezer and refrigerator should not exceed 45 days
- Shipper for up to 30 days with 6 dry ice recharges, replenish dry ice every 5 days
- Shipper can only be opened 2/day for up to 3 minutes
- Once a tray is removed it has started the thawing process and cannot be put back in the shipper
- Use the Controlant external data logger, included with the thermal shipping container, to monitor the temperature
- Return the shipping container empty with Controlant data logger after 30 days, using the shipping label provided
- Dry Ice Handling/Recharge job aid
Please use this job aid to help you update the expiration date in ASIIS for doses that have already been “received” into the ASIIS inventory.
For other information on the Comirnaty/Pfizer-BioNTech COVID-19 vaccine, providers can go to the Pfizer COVID-19 vaccine website, or the CDC Pfizer COVID-19 vaccine resources page.
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