Sanofi and GlaxoSmithKline (GSK) have reached an agreement, subject to a final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 vaccine developed by Sanofi in partnership with GSK. The vaccine is based on Sanofi’s recombinant protein-based technology used to produce an influenza vaccine and GSK’s adjuvant technology.

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 the 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.

The companies say that active discussions on the supply of the vaccine are ongoing with global organizations, the US, and the European Commission, with France and Italy on the negotiation team. The partners say they plan to provide a “significant” portion of total global available supply capacity in 2021/2022 to the global initiative, Access to COVID-19 Tools (ACT) Accelerator, a global mechanism co-chaired by the Bill & Melinda Gates Foundation and the World Health Organization focused on accelerating development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

GSK is also collaborating with other companies and research groups that are working on COVID-19 vaccine candidates through the use of its vaccine adjuvant technology. The company says it does not expect to profit from COVID-19 vaccines during the pandemic phase and will invest any short-term profit in COVID-19-related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.

In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is also developing a messenger RNA vaccine candidate in partnership with Translate Bio, a Lexington, Massachusetts-based company developing mRNA therapeutics. Sanofi expects a Phase I study to start by the end of the year, and, if the data are positive, an approval at the earliest in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 million to 360 million doses.

Source: GlaxoSmithKline and Sanofi