U.S. Government Invests $2.1 Billion to Accelerate Sanofi/GSK COVID-19 Vaccine Development

On July 31, Sanofi and GSK announced a partnership with the U.S. government to accelerate the development and manufacturing of a recombinant protein-based COVID-19 vaccine. Under this agreement, the U.S. government will provide $2.1 billion in funding, with more than 50% allocated to support vaccine development, including clinical trials. The remaining funds will primarily be used for the large-scale production and distribution of 100 million doses.

The vast majority of the $2.1 billion in funding provided by the U.S. government will be awarded to Sanofi. The U.S. government also retains the right to secure a long-term supply of 500 million vaccine doses. This collaboration is part of Operation Warp Speed, an initiative launched by the U.S. government in May to accelerate the development and production of COVID-19 vaccines and therapies.

“Operation Warp Speed” aimed to secure at least 300 million doses of COVID-19 vaccines by January 2021, with priority given to U.S. citizens. The U.S. government invested $456 million in March in the candidate vaccine from Janssen, a subsidiary of Johnson & Johnson; $486 million in April in the vaccine from the U.S. biotechnology company Moderna; $1.2 billion in May in the vaccine developed through the collaboration between AstraZeneca and the University of Oxford; and $1.95 billion in July in the vaccine jointly developed by Pfizer and BioNTech.

Sanofi and GSK announced on April 14 that they had signed a collaboration agreement to jointly develop an adjuvanted COVID-19 vaccine. The two companies will leverage their respective innovative technological strengths to collectively address the novel coronavirus outbreak. GSK will primarily contribute its proven vaccine adjuvant technology, which has been validated in responding to epidemics, while Sanofi will contribute its recombinant DNA technology to construct antigens capable of specifically binding to the S protein on the surface of the SARS-CoV-2 virus.

Sanofi is currently responsible for the clinical development of its COVID-19 vaccine, with Phase I/II clinical trials expected to commence in September and Phase III trials to begin by the end of 2020. Pending favorable data, a marketing authorization application will be submitted in the first half of 2021. Meanwhile, Sanofi and GSK are planning to expand antigen production capacity to help achieve a global annual production target of 1 billion doses of the COVID-19 vaccine.

In addition to the recombinant protein-based vaccine developed in collaboration with GSK, Sanofi has also partnered with Translate Bio to develop messenger RNA (mRNA) vaccine candidates. Currently, several innovative vaccine platforms are under investigation in the industry, with mRNA regarded as the most promising. Sanofi expects to initiate Phase I clinical trials by the end of this year; if the data are positive, approval could potentially be obtained as early as the second half of 2021. Translate Bio already possesses mRNA production capabilities, and Sanofi anticipates an annual production capacity of 90 million to 360 million doses.

Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, stated, “There is substantial global demand for COVID-19 preventive vaccines, and no single vaccine or company can meet this demand alone. Since the onset of the COVID-19 pandemic, Sanofi has leveraged its deep scientific expertise and resources to help address this crisis. Our collaboration with the U.S. Department of Health and Human Services has paved a fast track for the development and large-scale manufacturing of pandemic vaccines. Together with our partner GSK, we expect Phase I/II studies on the recombinant adjuvant approach to commence in September.”