UPDATED Pfizer COVID-19 Vaccine Storage Guidance

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
• The Fact Sheet for Healthcare Providers Administering Vaccine has been updated to reflect this revised storage time
• EUA Fact Sheets are also available on our COVID-19 Vaccine Provider Guidance website: www.Michigan.gov/COVIDVaccineProvider

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.

• Note: The vaccine can be moved from 2-week frozen storage to 1-month refrigerated storage for a total storage timeframe up to but not exceeding 45 days
• For Pfizer vaccine resources, visit the CDC Pfizer COVID-19 Vaccine Webpage and the Pfizer Manufacturer Website

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