Pfizer and BioNTech Submit New Vaccine Stability Data to FDA

Pfizer and BioNTech announced on Feb. 19, 2021 that they have submitted new data to FDA that shows the stability of their COVID-19 vaccine when stored at -25 to -15 °C; the companies propose an update to the vaccine’s Emergency Use Authorization prescribing information, allowing for the vials to be stored at the standard freezer temperatures for up to two weeks.

Currently, the vaccine must be stored in an ultra-cold freezer at temperatures between -80 and -60 ºC, where it can remain for up to six months. If the label change is approved, the vaccine can be stored for two weeks at -25 to -15 °C. Stability data were collected on batches manufactured over the past nine months of COVID-19 vaccine development.

“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 CEO, Pfizer, in the press release. “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.”

“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. 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,” added Ugur Sahin, CEO and co-founder of BioNTech, in the press release. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

Source: Pfizer