Sanofi, GlaxoSmithKline make coronavirus vaccine deal with U.S.

HHS and the U.S. Department of Defense (DoD) announced Friday agreements with Sanofi and GlaxoSmithKline to support advanced development, including clinical trials and large-scale manufacturing of 100 million doses of an investigational adjuvanted vaccine against COVID-19.

HHS and the U.S. Department of Defense (DoD) announced Friday agreements with Sanofi and GlaxoSmithKline to support advanced development, including clinical trials and large-scale manufacturing of 100 million doses of an investigational adjuvanted vaccine against COVID-19. HHS Secretary Alex Azar explained, "Today's investment supports our latest vaccine candidate, an adjuvanted product being developed by Sanofi and GSK, 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." The manufacturing demonstration project will take place while clinical trials are being conducted, which will expedite the traditional vaccine development timeline. The Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Army Contracting Command to provide about $2 billion to support late-stage development, clinical trials including a large-scale Phase III efficacy clinical trial, and the manufacturing demonstration project. The U.S. government also has the ability to acquire up to 500 million more doses. The deal also includes fill-finish manufacturing in the United States, so that vaccine doses are packaged and ready to go immediately if clinical trials are successful and FDA authorizes the vaccine's use. If the doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the public at no cost, though as is usual with government-purchased vaccines, health care professionals could charge for the cost of administering the vaccine.