FDA Authorizes Longer Time for Refrigeration Storage of Thawed Pfizer COVID-19 Vaccine Prior to Dilution

FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

• Based on a review of recent data submitted by Pfizer Inc. on May 19, the U.S. Food and Drug Administration is authorizing 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 vaccine vials could be stored in the refrigerator for up to 5 days.  
  
  
• Pfizer Inc. submitted data to the FDA to demonstrate that undiluted, thawed vials of its COVID-19 vaccine are stable at refrigerator temperatures for up to 1 month.
  
  
• The updated Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) is intended to help frontline workers understand the revised storage time. The Fact Sheet is available on the FDA’s web site.
  
  
• Emergency Use Authorization for Vaccines to Prevent COVID-19