The vaccine candidate, Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce influenza and GSK’s established pandemic adjuvant technology.
The doses would be manufactured in European countries including France, Belgium, Germany, and Italy. This marks a key milestone in protecting and serving the European population against the pandemic.
“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 providing 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,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.
“Together with GSK, we are working relentlessly to develop and produce a vaccine to address this global health crisis,” he added.
President of GSK Vaccines, Roger Connor added “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.”
Sanofi, which leads the clinical development and registration of the COVID-19 vaccine expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020.
If the data are positive, regulatory approval could be achieved by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.
GSK and Sanofi have been already selected by the U.S. government’s Operation Warp Speed to supply with 100 million doses of COVID-19 recombinant protein-based vaccine.
The companies also signed an agreement with the United States where they have a longstanding partnership with the Biomedical Advanced Research and Development Authority.