Agreements relate to vaccine candidate using Sanofi’s recombinant protein-based technology and GSK’s pandemic adjuvant
Sanofi and GSK have signed agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021.
Both companies have vaccine manufacturing sites in Canada contributing to overall global COVID-19 vaccine development.
The companies initiated a Phase I/II study on September 3 with a total of 440 subjects being enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year. If these data are sufficient for licensure application, its planned to request regulatory approval in the first half of 2021.
In parallel, the companies are are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally.
On September 18, Sanofi and GSK signed a final agreement with the European Commission to supply European countries with up to 300 million doses from their European industrial network. In July 2020, Sanofi and GSK announced a collaborative effort with the US government to supply up to 100 million doses of their vaccine to meet the US government’s Operation Warp Speed goal of making hundreds of millions of doses of COVID-19 vaccines available in the United States as quickly as possible. Both companies also agreed (subject to final contract) with the UK government to supply up to 60 million doses.
In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. Preclinical data shows that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase I/II study to start in November, with earliest potential approval in the second half of 2021. Translate Bio has mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.
“Today’s announcement showcases our unwavering commitment to develop a COVID-19 vaccine that is available to everyone when it comes to market,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. “To address a global health crisis of this magnitude, it takes partnerships and we are grateful to Canada for its collaboration, and to GSK for partnering with us to develop a safe and effective vaccine.”
Roger Connor, President of GSK Vaccines added, "GSK is proud to be working in partnership with Sanofi to make this vaccine available as soon as possible in Canada. Both companies have significant R&D and manufacturing capability world-wide and are already working hard to scale up production. This announcement from the Government of Canada supports our ongoing efforts.”