GSK and Sanofi are in negotiations with the European Commission ( EC) to supply up to three-hundred million doses of a COVID-19 vaccine. The vaccine candidate, developed in collaboration with GSK by Sanofi, is based on Sanofi's recombinant protein-based technology used to create an influenza vaccine, and GSK's adjuvant technology.
The clinical development and registration of the vaccine is being led by Sanofi and expects a Phase I/II study to begin in September, followed by a Phase III study nearer the end of 2020. If the data are positive, regulatory approval by the first six months of 2021 may be achieved. Furthermore, GSK and Sanofi are ramping up their manufacturing of the adjuvant and antigen to create up to one-billion doses every year.
“GSK and Sanofi in discussions with EC on the supply of up to three-hundred million doses of a COVID-19 vaccine.“
Global Head and Executive Vice President of Sanofi Pasteur, Thomas Triomphe, stated: "Today's announcement helps to ensure that millions of Europeans will have access to a potential vaccine protecting against COVID-19, once proven safe and effective. It has been our steadfast commitment to provide a vaccine that is affordable and accessible to everyone and we are grateful to the European Commission for their ongoing engagement and shared support of this effort. Together with GSK, we are working relentlessly to develop and produce a vaccine to address this global health crisis."
President of GSK Vaccines, Roger Connor, stated: "GSK is proud to be working in partnership with Sanofi to make this vaccine available as soon as possible in Europe. Both companies have significant R&D and manufacturing capability in Europe and are already working hard to scale up production across our networks. This announcement from the EC supports our ongoing efforts."