EMA Approves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution & Storage of Doses Across European Union

Pfizer Inc. and BioNTech SE recently announced the European Medicines Agency (EMA) approved storage of COMIRNATY at -25°C to -15°C for a total of 2 weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers. The new data is a testament to the companies’ ongoing commitment to developing this vaccine further and collecting data in order to support broader and more flexible vaccine distribution and inoculation.

With this approval, the COMIRNATY vials can be stored in all 27 European Union (EU) member states at these updated temperatures for a total of two weeks alternatively to the storage at ultra-low temperatures. It marks an important milestone in the vaccine roll-out, as it could allow storage in pharmacies to support vaccinations at local practices/doctors’ offices. By enabling more individuals to store and administer the vaccine, the approval will help broaden access, while limiting strain on larger vaccination centers.

“From the beginning our goal was to make our vaccine broadly available to people around the world. This approval by the EMA will enable us to access important additional channels to distribute and administer our vaccine,” said Ugur Sahin, CEO and Co-founder of BioNTech. “It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic.”

“We appreciate the collaboration with the EMA and other regulatory agencies around the world as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “This new storage option in Europe will help make the vaccine even more accessible to people across the continent, another important step as we continue our global fight against this virus.”

The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the US, UK, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.