New Storage Option OKd for Pfizer-BioNTech Vaccine, Easing Distribution, Storage Across EU

 BioNTech SE (Nasdaq: BNTX) announced today that the European Medicines

Agency (EMA) approved storage of COMIRNATY(R) at -25degC to -15degC for 
a total of two 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 United States, United Kingdom, 
Canada and other countries in advance of a planned application for full 
marketing authorizations in these countries. 

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