FDA Eases Temperature Requirements for Pfizer, BioNTech's COVID-19 Vaccine

If approved, the decision could have a significant impact on the mass vaccination programs.

Update 2/25/21: Today, the FDA announced that it will allow undiluted, frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at temperatures between -25 and -15 degrees Celsius instead of the initial -80 and -60 degrees Celsius. Additionally, vials stored at the higher temperatures may be returned to the lower, recommended temperatures 1 time.

“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said. “The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.”

The original article was published on February 19, 2021.

On Friday, Pfizer and BioNTech submitted data to the United States Food and Drug Administration (FDA) asking for an authorization to store their coronavirus disease 2019 (COVID-19) vaccine BNT162b2 at temperatures between -15 and -25 degrees Celsius, instead of the requirements that are now in place.

If the FDA approves the request, the change will allow for easier distribution, as the vaccine currently needs specialized shipping containers and storage facilities which certain pharmacies and healthcare providers do not always have readily available. The change would also allow for the expanding of immunizations, which have been plagued by manufacturing and supply chain issues.

The 2 companies have been conducting stability studies over the course of the past 9 months, which included doses from early clinical trials and those distributed in commercial-scale batches. The findings have shown that the doses of the vaccine are able to remain stable at warmer temperatures which are commonly found in pharmaceutical freezers and refrigerators.

“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 of Pfizer said. “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.”

The current regulations, as authorized by the FDA in their Emergency Use Authorization (EUA) of BNT162b2, state that the vaccine must be stored in ultra-cold freezers at temperatures between -80 and -60 Celsius. In these temperatures, the doses remain stable for up to 6 months.

Before the vaccine is mixed with a saline diluent, it must be refrigerated for up to 5 days at a standard temperature between 2 and 8 degrees Celsius. The vaccine is then administered at room temperature. The approval would allow the vaccine to be stored at the warmer temperatures for 2 weeks, in addition to the 5 days of refrigeration.

“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,” Ugur Sahin, CEO and Co-founder of BioNTech said. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”