On February 19, the U.S.-based Pfizer claimed in a release that its COVID-19 vaccine is stable when stored low temperature of -25 to -15 degree C, which are commonly found in pharmaceutical freezers and refrigerators. The stability data has been generated on batches manufactured over the past nine months of COVID-19 vaccine development.
On Friday, the U.S.-based Pfizer claimed in a release that its COVID-19 vaccine is stable when stored low temperature of -25 to -15 degree C, which are commonly found in pharmaceutical freezers and refrigerators. According to the release, data have been submitted to the FDA to support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information. It claims that the vaccine can be stored at low temperatures for a “total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer”.
On December 11, 2020 when the U.S. FDA approved the vaccine for emergency use, the storage temperature stipulated was -60 to -80 degree C. The labels for the vaccine too state that the vaccine must be stored at temperatures between -60 and -80 degree C. The vaccine remains stable at ultra-low temperature for up to six months.
The data submitted to the FDA includes low temperature (-25 to -15 degree C) stability data generated on batches manufactured over the past nine months of COVID-19 vaccine development. It includes “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”.
“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,” Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in the release.
“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” Ugur Sahin, CEO and Co-founder of BioNTech said in the release. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”
Before mixing with a saline diluent prior to administering the vaccine, the vaccine may also be refrigerated for up to five days at standard refrigerator temperature, between 2 and 8 degree C. “If approved, the option to store at -25 to -15 degree C for two weeks would be in addition to this five-day option to store at standard refrigerator temperature,” the release says.
Even developed countries did not have large numbers of ultra-low storage facilities at the time of approval. The ultra-low temperature required to store and transport the vaccine meant that most developing countries, which do not have the deep-freezer infrastructure, may not be able to handle the vaccine for large-scale immunisation.