Sanofi SA and GlaxoSmithKline Plc have received an approval from Indian authorities for a late-stage clinical trial of their protein-based COVID-19 vaccine candidate, the drugmakers said today.
France’s Sanofi and Britain’s GSK in May kicked off global trials to include more than 35,000 adults to test the shot. They hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response.
The Indian arm of the studies will enroll roughly 3,000 adults between the ages of 18 years and 55 years, according to India’s clinical trial registry.
The assessment is expected to run for a year and the first enrollment in India is shown to have been made on Tuesday.
The Indian drug regulator did not immediately respond to a request for comment.
As the virus continues to evolve, we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program, Annapurna Das, Sanofi’s India head, said in a statement.
The companies said study participants can get vaccinated with an approved COVID-19 shot during the study if they wish to.