GSK & Sanofi Jointly Launch Coronavirus Vaccine Study

Sanofi and GSK jointly announced on September 3, 2020, they are launching a Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine candidate. This protein-based adjuvanted vaccine development uses the same technology as one of Sanofi’s seasonal influenza vaccines, with GSK’s established pandemic adjuvant technology.

The Phase 1/2 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of the COVID-19 vaccine candidate with a total of 440 healthy adults, who are being enrolled in the trial across 11 investigational sites in the USA. The companies anticipate first results early December 2020 which will support the initiation of a Phase 3 trial in December 2020.

If data from these studies are sufficient for licensure application, these companies plan is to request regulatory approval in the first half of 2021.

The development of the adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.