GSK, Sanofi were selected by US Operation Warp Speed to provide a large supply.
The US government has reached a deal with pharmaceutical companies, GSK and Sanofi, to deliver 100 million doses of the vaccine they are working on.
“GSK is proud to be working in partnership with Sanofi to make this vaccine available at scale as soon as possible,” Roger Connor, president, GSK Vaccines stated. “We thank the US government for playing a very important role in providing early, significant funding to enable the development and scale-up of this potentially important vaccine.”
Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year globally.
“With our partner GSK, we expect our Phase 1/2 study for the recombinant adjuvanted approach to start in September,” Executive Vice President and Global Head of Sanofi Pasteur Thomas Triomphe said.
The US will fund up to $2.1 billion—more than half of which is to support further development of the vaccine, including clinical trials—with the remainder used for manufacturing scale-up and delivery of the initial 100 million doses of the vaccine. There is an option to buy additional 500 million doses longer term.
This initiative falls under the US government's Operation Warp Speed.
Collaborating with the US Department of Health and Human Services (HHS) and Department of Defense will help fund the development activities and secure scale-up of Sanofi’s and GSK’s manufacturing capabilities in the United States for the recombinant protein-based, adjuvanted vaccine, resulting in a significant increase in capacity.
Sanofi is leading the clinical development and registration of the COVID-19 vaccine and 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, the companies can request US regulatory approval in the first half of 2021.
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. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising.
Sanofi expects a Phase 1 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 to 360 million doses.
“The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone,” Triomphe said. “From the beginning of the pandemic, Sanofi has leveraged its deep scientific expertise and resources to help address this crisis, collaborating with the U.S. Department of Health and Human Services to unlock a rapid path toward developing a pandemic vaccine and manufacturing at large scale.”