VANCOUVER (NEWS 1130) – Pfizer-BioNTech is looking to get approval to be able to keep its COVID-19 vaccines in warmer temperatures.
The companies are asking the U.S. Food and Drug Administration for permission to store their vaccine at temperatures between -25°C to -15°C — which are more commonly found in pharmaceutical refrigerators and freezers.
Currently, Pfizer-BioNTech’s drug must be kept in ultra-cold freezers with temperatures between -80°C and -60°C. As a result, it has been difficult, especially in rural parts of Canada, to find deep freezers with the ability to store these vaccines at the recommended temperatures.
The companies say data gathered over the past several months will back up their request to be able to store the vaccines at warmer temperatures for a time. Keeping the drugs in the aforementioned ultra cold temperatures can extend the shelf life for up to six months.
“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the U.S. and around the world,” said Albert Bourla, Pfizer chairman and CEO. “We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”
Pfizer-BioNTech says it anticipates the shelf life or expiration date could even be extended as more information comes in.
The companies expect to submit the same request to other regulators around the world in the coming weeks.