Pfizer's COVID-19 Vaccine Could Leave the 'Deep-Freezer'
Germany-based BioNTech SE and Pfizer Inc. announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their experimental COVID-19 vaccine (Comirnaty) when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators.
Currently, the Comirnaty vaccine labels, including the EUA label in the U.S., indicate the COVID-19 vaccine must be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF).
“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 even greater flexibility,” said Ugur Sahin, CEO, and Co-founder of BioNTech, in a press release issued on February 19, 2021.
“We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”
The Pfizer-BioNTech COVID-19 Comirnaty Vaccine has not been approved or licensed by the U.S. FDA. Still, it has been authorized for emergency use under an Emergency Use Authorization to prevent COVID-19 for use in individuals 16 years of age and older.