The existing US Emergency Use Authorization (EUA) requires the vaccine to be kept in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF): as is also the case in other jurisdictions.
While the vaccine will still require ultra-cold freezer temperatures for storage, the companies now say the vaccine can be kept and distributed with standard pharmaceutical freezer and fridge equipment for almost three weeks: as opposed to just five days as is currently the case.
Pfizer and BioNTech say that short term temperature storage may be further assessed; adding that they anticipate shelf life and/or expiration data of the vaccine could also be extended.
“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 US and around the world,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“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.”
The data have been submitted to the FDA to support a proposed update to vaccine’s Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at temperatures of -25°C to -15°C (-13°F to 5°F) for a total of two weeks, as an alternative or complement to storage in an ultra-low temperature freezer.
The FDA submission includes stability data generated on batches manufactured over the past nine months of COVID-19 vaccine development, from the batches that supplied the earliest clinical trials through the commercial scale batches currently in production. These data also will be submitted to global regulatory agencies within the next few weeks.
Currently, labels for the Pfizer-BioNTech COVID-19 vaccine state that the vaccine must be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF). It can be stored at these temperatures for up to 6 months.
The vaccine can then be refrigerated for up to five days at standard refrigerator temperature, between 2⁰C and 8⁰C (36⁰F and 46⁰F), before mixing with a saline diluent.
If approved, the option to store at -25°C to -15°C (-13°F to 5°F) for two weeks would be in addition to this five-day option at standard refrigerator temperature.
