On Aug. 12, 2020, Pfizer and BioNTech announced that preliminary, peer-reviewed data from their BNT162 mRNA-based vaccine development program, Project Lightspeed, against SARS-CoV-2, were published online in the journal Nature. These preliminary clinical data on BNT162b1, a nucleoside-modified messenger RNA (modRNA) candidate that encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, showed that BNT162b1 was administered in a dose that was well tolerated and generated dose-dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing.

The posted preprint version of the manuscript reported that, by 7 days after the second dose, 30 g of BNT162b1 elicited a SARS-CoV-2 neutralizing geometric mean titer (GMT) 2.8-times the GMT of a SARS-CoV-2 convalescent human serum panel. Based on new data, the final, peer reviewed paper reports that neutralizing titers continued to rise, and, by 14 days after the second dose of 30 g, the participants’ GMT was 4.6-times the convalescent serum panel GMT.

The companies were also continuing the peer review process for initial data posted to the Medrxiv preprint server for BNT162b1 from the German Phase 1/2, open-label, non-randomized, nonplacebo-controlled, dose-escalation trial.