French pharmaceutical Sanofi and its British partner GlaxoSmithKline (GSK) on Thursday said they have received the approval of the drugs controller general of India to conduct part of the global phase-3 efficacy trial of their jointly developed covid-19 vaccine in India.
This will be the first such global trial for a foreign covid-19 vaccine to be conducted in India.
We believe our covid-19 adjuvanted, recombinant vaccine can make a significant contribution to the ongoing fight against covid-19 and are committed to initiating our clinical programme in India, at the earliest,” said Annapurna Das, country head of Sanofi Pasteur India.
In total, the companies plan to globally enrol around 35,000 participants in the age group of 18-55 years for the trial. In India, they plan to recruit 3,000 participants across three trial sites—Aartham Multi Super Speciality Hospital in Ahmedabad, Maharaja Agrasen Super Speciality Hospital in Jaipur and Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad—according to the government’s clinical trial registry.
The phase 3 trial will be conducted in two stages—one will look at the efficacy of the vaccine targeting the original coronavirus strain D.614, while the second will evaluate a second formulation targeting the beta variant B.1.351.