Start of Phase 2b/3 clinical trials in Bahia and São Paulo expected in early August

São Paulo, July 21, 2020 – Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today the selection of Brazil as one of the global locations for the impending Phase 2b/3 global clinical trial of its BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2.

The selection of Brazil as one of the global hosts of the study was based on the local scientific expertise and capabilities, the epidemiology of the disease, and Brazil’s prior experience running clinical trials. The study will be conducted in two sites - one in São Paulo (CEPIC - Centro Paulista de Investigação Clínica) and the other in Bahia (Instituição Obras Sociais Irmã Dulce). The trials received regulatory approval on Monday by Brazil’s Health Authority, ANVISA.

Dr. Edson Moreira, PhD in epidemiology from Columbia University in New York and post-doctoral fellow at McGill University in Montreal, will be the study’s Lead Principal Investigator.

“We are proud to have Brazilian patients enrolled in this global research effort, which may play a critical role in the fight against COVID-19. We are confident in the success of our trials and that science will win against this pandemic,” said Dr. Moreira.

Pfizer and BioNTech have previously stated that they expect the Phase 2b/3 clinical trial of BNT162 to begin in late July in select global markets, pending the appropriate regulatory clearances.  

Both companies will continue to evaluate the clinical development plan over time and assess the need for and feasibility of additional sites.