BARDA and Sanofi Pasteur, the vaccines global business unit of Sanofi, are expanding their collaboration to develop a SARS-CoV-2 vaccine. The previously announced research for a COVID-19 vaccine using a recombinant DNA platform will accelerate into non-clinical studies and a Phase 1 clinical trial to demonstrate initial safety and efficacy of the vaccine candidate.
The recombinant DNA vaccine technology produces an exact genetic match to proteins of the virus. The protein’s DNA is combined with DNA from a virus harmless to humans, and used to rapidly produce large quantities of antigen which stimulate the immune system to protect against the virus. The antigens are separated and collected from these cells and purified to create working stocks of vaccine for advanced development.
The technology was developed with BARDA support to make millions of doses of vaccine quickly in an influenza pandemic, and Sanofi uses the platform for its FDA-licensed seasonal influenza recombinant vaccine. Activities also include regulatory support and process development for manufacturing large scale manufacturing in the United States, and planning for advanced stage clinical trials.