Sanofi and GSK have received the approval to conduct the phase 3 trial of their Covid-19 vaccine in India. The study will estimate the safety, effectiveness, and immunity of their assistant recombinant-protein vaccine candidate.
“India is participating in Sanofi Pasteur’s phase 3 study, and subject to following approvals, we should soon begin enrollment of study participants in the country,” said Annapurna Das, Country Head, Sanofi Pasteur India. The phase 3 study will include more than 35,000 volunteers from age 18 and more across sites in the United States, Asia, Africa, and Latin America, Sanofi said in a statement. As the coronavirus continues to grow, “we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program,” Das added.

The primary endpoint of the study is the prevention of Covid-19 in SARS-CoV-2 in adults, with secondary endpoints being the prevention of severe Covid-19 infections and prevention of asymptomatic infection, Sanofi said.
The study will first examine the efficacy of a vaccine formulation targeting the original virus strain, while a second stage will estimate a second formulation targeting the Beta variant, it added. In addition to the adjuvanted recombinant protein-based vaccine in collaboration with GSK, Sanofi is also developing a messenger RNA vaccine in partnership with Translate Bio.