Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature.
Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, with preferred storage set in an ultra-low temperature freezer between -80ºC to -60ºC.
As a result of the approval, vials of the vaccine can be stored in all 27 European Union (EU) member states at the updated temperatures as an alternative to the ultra-low requirements, offering flexibility to distribution and inoculation, according to a news release.
“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,” BioNTech CEO & co-founder Ugur Sahin said in the release. “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.”
Ultra-low temperature storage requirements are intended to protect the mRNA in the vaccines. Leaked documents reviewed by the BMJ indicated initial struggles with mRNA stability in the Pfizer/BioNTech vaccine, but those issues have since been resolved.
“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,” added Pfizer chairman & CEO Albert Bourla. “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.”