The data have been submitted to the FDA to support a proposed update to the US Emergency Use Authorisation (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.
The FDA submission includes stability data generated on batches manufactured over the past nine months of Covid-19 vaccine development, from the batches that supplied the earliest clinical trials through the commercial scale batches currently in production. These data also will be submitted to global regulatory agencies within the next few weeks.
“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 chief executive officer, Pfizer.
“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 centres 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 centres an even greater flexibility,” said Ugur Sahin, CEO and co-founder of BioNTech.
“We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”
Currently, the labels for the Pfizer-BioNTech Covid-19 vaccine, including the EUA label in the US, state that the vaccine must be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to 76ºF).
It can remain stored at these temperatures for up to six months. The vaccines are shipped in a specially-designed thermal container that can be used as temporary storage for a total of up to 30 days by refilling with dry ice every five days. Before mixing with a saline diluent, the vaccine may also be refrigerated for up to five days at standard refrigerator temperature, between 2⁰C and 8⁰C (36⁰F and 46⁰F).
If approved, the option to store at -25°C to -15°C (-13°F to 5°F) for two weeks would be in addition to this five-day option to store at standard refrigerator temperature. The vaccine is administered at room temperature by medical staff.
As additional stability data are obtained, Pfizer and BioNTech anticipate the shelf life and/or expiration date could be extended, and alternate short-term temperature storage may be considered.
The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the marketing authorisation holder in the European Union, and the holder of emergency use authorisations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorisations in these countries.
The Pfizer-BioNTech Covid-19 vaccine is authorised for use under an EUA for active immunisation to prevent Covid-19 caused by severe acute respiratory syndrome coronavirus 2 (Sars-CoV-2) in individuals 16 years of age and older.
The Pfizer-BioNTech Covid-19 vaccine has not been approved or licensed by the US FDA, but has been authorised for emergency use by FDA under an EUA to prevent Covid-19 for use in individuals 16 years of age and older.