Sanofi and GSK Announce Collaboration to Develop Adjuvanted Recombinant COVID-19 Vaccine Targeting Second-Half 2021 Approval

On April 14, Sanofi and GlaxoSmithKline announced that they had signed a letter of intent to collaborate on the co-development of an adjuvanted COVID-19 vaccine. The two companies will leverage their respective innovative technological strengths to jointly address the ongoing novel coronavirus outbreak.

Sanofi will contribute its recombinant DNA technology to construct antigens that specifically bind to the S protein on the surface of the SARS-CoV-2 virus. Several recombinant vaccine products currently approved by Sanofi in the United States are based on this technological platform, which involves integrating DNA sequences encoding specific antigens into baculovirus DNA for expression.

GSK will contribute its proven vaccine adjuvant technology, which has been validated in responding to epidemics. Adjuvants added to vaccines can enhance the body’s immune response, generating stronger and more durable immune protection. Reliable vaccine adjuvants are critical in addressing large-scale epidemics, as they reduce the amount of protein required per vaccine dose. This significantly scales up vaccine production capacity, enabling the manufacture of more doses and helping to protect more people.

Sanofi CEO Paul Hudson stated, “As the world grapples with this unprecedented health crisis, it is clear that no company can address it alone. This is why Sanofi continues to collaborate with industry peers, such as GSK. By leveraging complementary technological capabilities and specialized resources, our goal is to manufacture and supply sufficient quantities of vaccines to help halt the spread of the virus.”

GSK CEO Emma Walmsley stated, “This collaboration brings together the world’s two largest vaccine companies. By combining our scientific expertise, technologies, and capabilities, we are confident that we can accelerate the development of COVID-19 vaccines and protect as many people as possible from COVID-19.”

The two companies have established a joint task force, co-led by David Loew, Global Head of Sanofi Vaccines, and Roger Connor, President of GSK Vaccines. The task force will mobilize resources from both companies to identify all possible opportunities to accelerate vaccine development. The two companies plan to initiate Phase I clinical trials in the second half of 2020. If successful, they expect to complete all clinical development of the vaccine and obtain formal regulatory approval for market launch by the second half of 2021.

Given the immense humanitarian and financial challenges posed by the COVID-19 pandemic, both companies recognize that vaccine research and development is an urgent priority, and are committed to ensuring equitable access to vaccines for populations in all countries through affordable collaborative arrangements. The two companies have signed a Material Transfer Agreement to enable immediate commencement of work, with the final terms of the collaboration expected to be finalized in the coming weeks.

Sanofi previously announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA), under the U.S. Department of Health and Human Services, to develop a recombinant COVID-19 vaccine, securing financial support in the process. Sanofi and GSK plan to engage with additional government agencies worldwide to seek further funding.

Dr. Rick A. Bright, Director of BARDA, stated: “Strategic alliances among leading vaccine manufacturers are critical to the successful and rapid development of coronavirus vaccines. The development of adjuvanted recombinant COVID-19 vaccines will expand production capacity to meet the vaccination needs of a larger population, helping to bring the current pandemic to an end as quickly as possible, improve global health, and strengthen preparedness against future outbreaks of coronavirus diseases.”