The U.S. government has earmarked $2.1B in total funds to support the development and production of a potential COVID-19 vaccine from pharmaceutical companies Sanofi Pasteur and GlaxoSmithKline (NYSE: GSK).
Sanofi said Friday the money will help the drugmakers put a recombinant protein-based vaccine candidate through clinical trials and manufacture the first 100M doses for the Trump administration’s Operation Warp Speed.
Phase 1 and 2 tests of the adjuvanted vaccine are scheduled to commence in September and a phase 3 study is slated to begin by the end of the year.
The two companies expect to receive regulatory approval to conduct large-scale and additional manufacturing efforts in the first half of 2021 if the trials are successful.
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said Alex Azar, secretary at the Department of Health and Human Services.
Discussions with the EU Commission are underway regarding global access to the Sanofi-GSK vaccine over the next two years.
Sanofi is also working with Translate Bio to develop a messenger RNA-based vaccine and expects to initiate phase 1 trials by the end of the year.