GSK and Sanofi Collaborate with US Government for Development of COVID-19 Recombinant Protein-Based Vaccine

(Paris, France) will collaborate with the US 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. 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 US 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.

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 US for the recombinant protein-based, adjuvanted vaccine, resulting in a significant increase in capacity. The US government will provide up to USD 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 US government funding. The US government has a further option for the supply of an additional 500 million doses longer term. This helps the US 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.”

“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,” added Roger Connor, President of GSK Vaccines.

Separately, Sanofi and GSK are in advanced discussions with the European Commission (EC) 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.

“Today’s announcement helps to ensure that millions of Europeans will have access to a potential vaccine protecting against COVID-19, once proven safe and effective. It has been our steadfast commitment to provide a vaccine that is affordable and accessible to everyone, and we are grateful to the European Commission for their ongoing engagement and shared support of this effort,” said Triomphe. “Together with GSK, we are working relentlessly to develop and produce a vaccine to address this global health crisis.”

“GSK is proud to be working in partnership with Sanofi to make this vaccine available as soon as possible in Europe. Both companies have significant R&D and manufacturing capability in Europe and are already working hard to scale up production across our networks. This announcement from the EC supports our ongoing efforts,” added Connor.

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