On Sept. 30, 2020, Pfizer and BioNTech announced that preliminary, peer-reviewed data from their ongoing German Phase 1/2 Study of BNT162b1 were published online in the journal Nature. BNT162b1 is part of the companies’ mRNA-based vaccine development program against SARS-CoV-2. The preliminary clinical data from the German study of BNT162b1, a nucleoside-modified messenger RNA (modRNA) candidate that encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, supported and expanded the data from the Phase 1/2 US study. BNT162b1 administered at dose levels that were well tolerated, generated dose level-dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers. In addition, the initial German trial results demonstrated, for the first time for the BNT62b1 candidate, a concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD. The data were initially made available to the public on July 20, 2020 via the online preprint server, medRxiv.

The companies are also continuing the peer-review process for other previously announced results from their BNT162b2 studies. As previously announced, BNT162b2 has been selected as the vaccine candidate to advance into a Phase 2/3 study based on the totality of available data from preclinical and clinical studies. As of today, the trial has enrolled over 35,000 participants, and the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.

The Phase 2/3 study is an event-driven trial that is planned to enroll up to 44,000 participants between 16 and 85 years of age. The companies are enrolling a diverse population, including participants in areas where there is significant expected SARS-CoV-2 transmission.