FDA Authorizes Longer Time for Refrigerator Storage of Pfizer-BioNTech COVID-19 Vaccine

FDA has amended the Pfizer EUA to allow undiluted, thawed Pfizer COVID-19 Vaccine vials to be stored in the refrigerator at 2^oC - 8^oC for up to 1 month. 

• The Pfizer COVID-19 vaccine vials must remain undiluted to remain at 2^oC - 8^oC for 1 month.   
• The up to 1-month 2^o- 8^o C storage duration must be within the labeled expiration date (i.e., not cumulative).

Step down storage & handling for Pfizer COVID vaccines is now as follows:

• All Pfizer configurations are shipped ultra-cold
• Ultra-Cold (-70)
• May be stored in ULT freezer until the expiration date, or temporarily in the shipper with regular dry ice replenishment.
• Frozen (-20)
• Pfizer COVID-19 vaccine vials may remain frozen at -20^oC for up to 2 weeks. (unchanged)
• Refrigerated (2-8)
• Pfizer COVID-19 undiluted vaccine vials may remain at 2^oC - 8^oC for 1 month.
• Total storage time for Pfizer in the freezer and refrigerator should not exceed 45 days.

https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine