FDA Authorizes Longer Refrigeration Period for a mRNA COVID-19 Vaccine

The federal agency elongates the time from 5 days up to 1 month for thawed out doses of the Pfizer-BioNTech vaccine.

In a move that should aid vaccine providers, the Food and Drug Administration (FDA) changed its authorization for the amount of time the Pfizer-BioNTech COVID-19 vaccine can be stored in refrigeration.

Once the vaccine is thawed out, it can now be kept in refrigeration for up to 1 month. Previously, it had been allowed to be stored in refrigerators for up to 5 days.

Pfizer submitted data to the FDA demonstrating that undiluted, thawed vials of its vaccine were stable at refrigerator temperatures for up to 1 month. Thawed vials should be refrigerated at 2°C to 8°C (35°F to 46°F).

One of the ongoing concerns has been that as vaccine supplies continue to be widely available and a limited need for the vaccine, the vaccine supply can be left unused. With a previously shorter window of time for the vaccine’s viability it made it challenging. This increased storage time offers more flexibility to vaccine providers.

“Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said. “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.”