Sanofi and GlaxoSmithKline (GSK) has formed a $2.1-billion pact with the US government for the development and manufacturing of their COVID-19 vaccine candidate and are in advanced discussions with the European Commission for the supply of up to 300 million doses of the vaccine.

Sanofi and GSK are partnered to develop a recombinant protein-based vaccine against COVID-19 based on Sanofi’s recombinant protein technology that it used to produce an influenza vaccine and GSK’s adjuvant technology.

The US government (the US Department of Health and Human Services and the US Department of Defense) will provide up to $2.1 billion to the companies with more than half being used to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. Sanofi will receive the majority of the US government funding. The US government has a further option for the supply of an additional 500 million doses longer term. The funding is part of Operation Warp Speed, a US government initiative to accelerate the development of vaccines and treatments against COVID-19.

Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase I/II study to start in September (September 2020) followed by a Phase III study by the end of 2020. If data are positive, regulatory approval could be achieved by the first half of 2021, according to the companies. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.

In a separate development, Sanofi and GSK are in advanced discussions with the European Commission for the supply of up to 300 million doses of their COVID-19 vaccine. The doses would be manufactured in European countries, including France, Belgium, Germany, and Italy.

In addition, GSK and Sanofi say they also plan to provide a significant portion of total global available supply capacity in 2021/22 to Access to COVID‐19 Tools (ACT) Accelerator, a global collaboration of governments, global health organizations, businesses, and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

Source: Sanofi (US government), GlaxoSmithKline (US government), Sanofi (European Commission), and GlaxoSmithKline (European Commission)