Pfizer and BioNTech Advance Lead mRNA-Based COVID-19 Vaccine Candidate BNT162b2 into Global Phase 2/3 Clinical Trial

Pfizer and BioNTech Announce Launch of Global Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of Their mRNA-Based COVID-19 Vaccine Candidate BNT162b2 in Preventing COVID-19. The Clinical Trial Is Expected to Enroll 30,000 Volunteers.

The BNT162 development program, jointly conducted by Pfizer and BioNTech, initially included four different mRNA vaccines. BNT162b2, the candidate that advanced into Phase 2/3 clinical studies, is an mRNA vaccine encoding the full-length spike protein of SARS-CoV-2 and was recently granted Fast Track designation by the U.S. FDA.

Preliminary phase 1/2 clinical data from nearly 120 volunteers indicate that BNT162b2 has a better overall tolerability profile than BNT162b1 (which encodes the receptor-binding domain of the spike protein). The geometric mean titers (GMTs) of neutralizing antibodies elicited by two 30-µg doses of BNT162b2 were broadly similar to those elicited by the BNT162b1 candidate vaccine. In older adults (aged 65–85 years), two 30-µg doses of BNT162b2 administered three weeks apart induced higher neutralizing antibody titers than those observed in convalescent serum samples from COVID-19 patients, which served as controls.

Compared with BNT162b1, vaccination with BNT162b2 induces T cells in subjects to recognize a greater number of epitopes on the SARS-CoV-2 spike protein. BNT162b2 also elicits robust CD4+ and CD8+ T cell responses. Pfizer and BioNTech believe that the ability to recognize more spike protein epitopes may lead to more consistent immune responses across different populations, including older adults.

This Phase 2/3 clinical trial is a randomized, blinded study expected to enroll 30,000 participants aged 18–85 years, receiving two doses of 30 µg each. The primary endpoints are the efficacy in preventing COVID-19 among individuals without prior SARS-CoV-2 infection and in the overall population. The secondary endpoint is the efficacy in preventing severe COVID-19.

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