KEY POINTS

  • FDA authorized longer storage time of thawed Pfizer COVID-19 vaccines
  • Pfizer COVID-19 vaccine vials can now be stored at 2°C to 8°C
  • The vaccines were initially required to be stored in ultra-cold temperatures

In an effort to make the COVID-19 vaccine more widely available to the public, the U.S. Food and Drug Administration (FDA) on Wednesday has authorized the storage of thawed Pfizer-BioNTech COVID-19 vaccines at standard freezer temperatures for up to one month.

Based on data submitted by Pfizer, the FDA said it is now allowing vaccinators to store undiluted, thawed vaccine vials in refrigerators at 2°C to 8°C for up to one month.

It earlier said thawed vaccine vials can only be stored at refrigerator temperatures for up to five days.

“Pfizer Inc. submitted data to the FDA to support storage of undiluted, thawed vials of its COVID-19 vaccine for up to one month at refrigerator temperatures,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

He noted that making COVD-19 vaccines widely available was the “key” to getting people vaccinated and bringing the pandemic to an end.

“This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store and administer the vaccine.”

In February, the FDA approved the storage and transportation of vaccines at “conventional temperatures” found in pharmaceutical freezers for up to two weeks.

Pfizer vaccines were previously required to be stored in ultra-low temperatures between -80ºC to -60ºC.

“The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get [a] vaccine to more sites,” Marks said at that time.

The Centers for Disease and Control Prevention said that temperature ranges for COVID-19 vaccines differ from other vaccines.

"Vaccines exposed to storage temperatures outside the recommended ranges may have reduced potency, creating limited protection and resulting in the revaccination of patients and thousands of dollars in wasted vaccine," it said.

vials of Comirnaty vaccine by Pfizer-BioNTech against Covid-19
This picture taken on May 13, 2021, shows vials of Comirnaty vaccine by Pfizer-BioNTech against Covid-19 in a fridge at the Baleone vaccine centre in Ajaccio on the French Mediterranean island of Corsica. - Vaccination is opened for people over 18 years old since early May in Corsica. The island has the highest vaccination rate in France. PASCAL POCHARD-CASABIANCA/AFP via Getty Images