If approved as part of a proposed update to the Emergency Use Authorization, the findings could make Pfizer and BioNTech’s COVID-19 vaccine more widely available.
Pfizer and BioNTech have submitted new data to the FDA demonstrating the stability of their coronavirus disease 2019 (COVID-19) vaccine at storage temperatures of -13 degrees to 5 degrees Fahrenheit. If approved as part of a proposed update to the Emergency Use Authorization, the findings could make their vaccine more widely available.
According to a press release, the updated prescribing information would allow for the vials to be stored up to 2 weeks at these temperatures, as opposed to storage in an ultra-low temperature freezer. The data include information on stability generated from batches manufactured over the past 9 months of the pandemic.
“Our top priority was to quickly develop a safe and effective vaccine and make it available to the most vulnerable people in the world in order to save lives,” said Ugur Sahin, MD, chief executive officer of BioNTech, in the press release. “At the same time, we have continuously collected data that could enable storage at around -20 degrees Celsius. The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility.”
According to current authorizations, the vaccine vials must be stored in freezers at temperatures between -112 degrees and -76 degrees Fahrenheit, where they can be stored for up to 6 months. Before mixing with a saline diluent, they may also be refrigerated for up to 5 days at standard refrigerator temperatures between 36- and 46-degrees Fahrenheit. These ultra-cold temperatures currently limit the facilities that can stock the vaccine, as most standard retail pharmacies or clinics may not have those freezers.
“We have been continuously performing stability studies to support the production of the vaccine at commercial sale, with the goal of making the vaccine as accessible as possible for health care providers and people across the US and around the world,” said Albert Bourla, DVM, PhD, chairman and chief executive officer at Pfizer, in the press release.
Notably, the press release said they expect that the shelf life or expiration date could be extended as additional stability data are obtained, and alternate short-term temperature storage may be considered. The data will also be submitted to global regulatory agencies in the coming weeks.
Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data At Standard Freeze Temperature To the US FDA [news release]. Pfizer; February 19, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data. Accessed February 19, 2021.