Clinical Trial Info

Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Lyophilized Formulation of BNT162b2 Against COVID-19 in Healthy Adults

Authored by
Last Reviewed
August 23, 2021

This Phase 3 study will evaluate in 610 participants the safety and tolerability of lyophilized BNT162b2 presented in single-dose vials and of frozen liquid BNT162b2 in multidose vials and demonstrate that the immune response of the lyophilized formulation is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate).

As a 2-dose schedule (separated by 21 days)

At a dose of 30µg (as studied in the Phase 2/3 study C4591001)

In healthy adults 18 through 55 years of age

The duration of the study for each participant will be approximately 2 months (3 visits in total)

The study will be conducted in the United States