July 31, 2020 – Sanofi (Paris, France) and GSK (London, UK) announced a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD) will help fund the development activities and secure scale-up of Sanofi’s and GSK’s manufacturing capabilities in the U.S. for the vaccine, which the companies say will allow them to significantly increase production capacity.
The U.S. government will provide up to $2.1 billion, more than half of which will be 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. The U.S. government has a further option for the supply of an additional 500 million doses longer term.
The companies expect to start a Phase 1/2 study in September, followed by a Phase 3 study by the end of 2020. If the data is positive, the companies can request U.S. regulatory approval in the first half of 2021. To ensure that the vaccine can be immediately available following approval, Sanofi and GSK are also currently working to scale up manufacturing of the antigen and adjuvant to produce up to one billion doses per year globally.