Sanofi and GSK Selected for Operation Warp Speed

Sanofi and GSK have formed an agreement 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 technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.
 
Collaborating with the U.S. 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.
 
The U.S. government will provide 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 an initial 100 million doses of the vaccine. Sanofi will receive the majority of the U.S. government funding. The U.S. government has a further option for the supply of an additional 500 million doses longer term. This helps the U.S. government’s Operation Warp Speed goals of providing millions of doses of a safe and effective COVID-19 vaccine.
 
“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,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. “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. With our partner GSK, we expect our Phase 1/2 study for the recombinant adjuvanted approach to start in September.”
 
Roger Connor, President of GSK Vaccines added, “GSK is proud to be working in partnership with Sanofi to make this vaccine available at scale as soon as possible. We thank the U.S. government for playing a very important role in providing early, significant funding to enable the development and scale-up of this potentially important vaccine.”
 
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar. “Today’s investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
 
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 data are positive, the companies can request U.S. regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year globally.