Can you explain the lyophilization process and how the lyophilized BNT162b2 vaccine is different?
The lyophilized formulation is a single dose product prepared by filling vaccine solution into a vial, then lyophilizing or freeze drying the contents of the vial to a powder. The vaccine is more stable in a powder form than liquid, and the lyophilized formulation is designed to be able to be shipped and stored at 2-8 °C. Prior to vaccination, the powder is reconstituted by dissolving with a diluent.
Why is it important for a refrigerator-stable version of the vaccine to be available?
Despite the work we have done to broaden access through improvements to our cold chain distribution systems and processes, the current storage requirements are not always available in some parts of the world. A refrigerator-stable formulation of our vaccine would be an important solution for increasing vaccine accessibility worldwide.
When will results from this study be available? When will the lyophilized vaccine be authorized and available for distribution?
Results are anticipated in the second half of 2021. Subject to technical success, we will then seek regulatory authorization or approval.