CLARIFICATION Re: UPDATED Pfizer COVID-19 Vaccine Storage Guidance

Michigan Dept of Health & Human Services sent this bulletin at 05/21/2021 03:23 PM EDT

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This message was sent to AIM, FAB, Health Systems, INE, IAP, LHD Health Officers, LHD Medical Directors, MACI, MACI 2, PH Imms Leads, MCIR Region Contacts, COVID-19 Vaccine Providers, and Imms All Staff. I apologize for any duplications.

 

Good Afternoon Immunization Partners, 

We would like to provide a point of clarification to the email below. We have reached out to Pfizer to inquire how they define “1 month” in relation to the updated refrigeration storage timeframe. They have advised that “The up to 1 month permitted for storage at 2°C to 8°C as per the authorized EUA Prescribing Information may be read as ‘up to 31 days’".

We have also confirmed this timeframe with CDC who affirmed its accuracy (up to 1 month = up to 31 days). CDC intends to have their updated materials posted to the CDC’s Pfizer-BioNTech COVID-19 Vaccine product webpage within the next couple of days: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html

We hope this information is helpful.

Thank you!

The Immunization Nurse Education Team,
-Andrea, Heidi, Maria, Sarah, and Terri

 

Email disseminated 5/20/21:

Good Morning Immunization Partners,

Storage conditions have been expanded for refrigerated timeframes of Pfizer-BioNTech COVID-19 Vaccine – a change that can promote vaccine availability for even more vaccine providers in the community and thereby more residents across the state. Please review the following updated information:

  • The U.S. Food and Drug Administration (FDA) has authorized undiluted, thawed Pfizer-BioNTech COVID-19 vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month
    • Previously, thawed, undiluted vials could be stored in the refrigerator for up to 5 days
    • Reminder about thawing: A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator (whereas fewer vials will thaw in less time)
    • This 1-month refrigerated storage duration must be within the labeled expiration date
    • Do not re-freeze thawed vials

To review overall storage guidelines for Pfizer vaccine, below is a step-down review:

  • Pfizer COVID-19 vaccine is shipped at ultra-cold temperatures
  • Ultra-Cold Storage
    • May be stored in an ultra-cold freezer between -80°C to -60°C (-112°F to -76°F) until the expiration date
    • May be stored temporarily in the thermal shipper with dry ice replenishment for up to 30 days
  • Frozen Storage
    • May be stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks
  • Refrigerated Storage
    • Undiluted, thawed vials may be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

Previous storage requirements of this vaccine have been cited as a barrier for some providers, so this change may assist in alleviating such concerns. We encourage enrolled COVID-19 Vaccine Providers to utilize this change as an opportunity to engage in providing this vaccine (if not already). This may be accomplished via placing an E-Order in MCIR or seek out redistributed vaccine (of smaller quantities) from a nearby provider with Pfizer vaccine such as a Local Health Department. Ensuring Pfizer vaccine availability is an important step for adolescent vaccination efforts.

Additionally, Pfizer anticipates shipments of smaller order quantities to begin in early June: orders of 450 doses becoming available (the 1170-dose order quantities will also remain available). As we gather more information on these smaller order quantities, we will share this with you.

If you have questions, please contact checcimms@michigan.gov

Thank you,

The Immunization Nurse Education Team,
-Andrea, Heidi, Maria, Sarah, and Terri