Pfizer Inc. and BioNTech SE filed new data with the FDA last week that could allow pharmacies without a special freezer to store the vaccine jointly developed by the companies for up to 2 weeks.
When the FDA granted the Pfizer-BioNTech vaccine Emergency Use Authorization in mid-December, it specified that doses had to be stored at -80ºC and -60ºC (-112ºF to ?76ºF), temperatures only reached by ultra-cold freezers. The vaccine ships in custom-designed thermal containers that use dry ice to maintain sufficiently low temperatures for up to 30 days. Before dilution, the vaccine can be stored in a standard refrigerator for up to five days at 2?C and 8?C (36?F and 46?F).
As the vaccine also ships in trays containing a minimum of 975 doses, many small vaccination sites would need to store the vaccines longer than 5 days. The cost of the specialty freezers precluded their purchase by many pharmacies and smaller hospitals, so they’ve had to share shipments sent to larger facilities that could store the vaccine. That has stymied distribution in the U.S. and abroad.
Specifying the original super cold temperatures allowed the companies to get their vaccine authorized first, but Pfizer and BioNTech recognized that providing more widely achievable conditions for storage would expand the settings in which their vaccine could be used.
“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, CEO and co-founder of BioNTech. “At the same time, we have continuously collected data that could enable storage at around -20°C. The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility.”
The latest filing indicates that the vaccine can be stored at -25°C to -15°C (-13°F to 5°F), temperatures commonly reached by standard pharmacy freezers, for up to 2 weeks. The new recommendations are based on 9 months of data.
“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’s chairman and CEO. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”
The companies noted that the shelf life or expiration date of the vaccine could be extended, as additional stability data are evaluated. Other changes to short-term storage recommendations could also be made in the future.
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