BRIEF—Sanofi and GSK initiate Phase I/II COVID-19 vaccine trial

Sanofi and GlaxoSmithKline announce today the start of the Phase I/II clinical trial for their adjuvanted COVID-19 vaccine.

The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi's seasonal influenza vaccines with GSK's established pandemic adjuvant technology.

A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the USA.

The companies anticipate first results in early December 2020, to support the initiation of a Phase III trial in December 2020.

If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021.

In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 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 (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.