BackSanofi, GSK get nod for phase 3 trial of covid-19 vaccine in India
This will be the first global trial for a foreign covid-19 vaccine to be conducted in IndiaIn India, the pharma majors plan to recruit 3,000 participants across three trial sites in Ahmedabad, Jaipur and Hyderabad
PremiumFrench 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.
“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. 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.
The partnership between rivals Sanofi and GSK is unprecedented in the global pharma industry. While Sanofi has developed the antigen—the main component of the vaccine that contains spike proteins of the coronavirus—GSK is supplying its ‘pandemic adjuvant’, which will be used to boost the immune response of the antigen.
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.
So far, the trial sites in Ahmedabad and Jaipur have received approval from their respective non-independent institutional ethics committees, while Hyderabad’s NIMS is still awaiting it, according to the registry.
Sanofi, which is leading the trial, and its British partner had already started recruiting participants for its phase 3 trial in the US in late May and have plans to initiate the process in several countries in Asia, Africa and Latin America in the coming weeks.
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.
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