Studies to Address New Formulations

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Lyophilized Formulation Trial

Pfizer and BioNTech initiated a Phase 3 study evaluating a lyophilized (freeze-dried) formulation of the Pfizer-BioNTech COVID-19 vaccine designed to be refrigerator stable.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet here.

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.