FDA, EMA Approve Lengthened Storage Time for Pfizer/BioNTech Vaccine

The FDA and European Medicines Agency (EMA) have eased the ultra-cold storage requirements for the Pfizer/BioNTech COVID-19 vaccine, permitting doses to be held longer at normal refrigeration temperatures.

The regulators said unopened, thawed vials may be held at temperatures of 35 degrees to 46 degrees Fahrenheit (2 degrees to 8 degrees Celsius) for up to one month, instead of five days as previously authorized. The revised authorizations were based on new stability data submitted by the companies.

The change is expected to have a significant impact on distribution as the vaccine’s previous ultra-cold storage requirements, -112 degrees to -76 degrees Fahrenheit (-80 degrees to -60 degrees Celsius), required the use of special thermal containers for shipping, which kept the vaccine viable for up to a month but only if dry ice was added every five days.