The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) awarded a contract of up to $2.1 billion to Sanofi and GlaxoSmithKline (GSK) to help accelerate development and manufacturing of a COVID-19 vaccine candidate, according to press releases from HHS and Sanofi.
The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology, Sanofi said.
Of the $2.1 billion, more than half will 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. HHS has a further option for the supply of an additional 500 million doses longer term.
The Biomedical Advanced Research and Development Authority (BARDA), 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 negotiate the contract.
The project also includes fill-finish manufacturing in the United States, so that vaccine doses are packaged and ready to ship immediately if clinical trials are successful and the U.S. Food and Drug Administration (FDA) authorizes the use of the vaccine, HHS said. If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is also developing a messenger RNA vaccine candidate in partnership with Translate Bio, of Lexington, MA. Sanofi expects a Phase 1 study to start by the end of the year, and, if the data are positive, an approval at the earliest in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.
