Mumbai: French pharmaceutical giant Sanofi and its British partner GlaxoSmithKline plc have received approval from the Drugs Controller General of India to conduct a part of the global phase-3 efficacy trial of their jointly-developed covid-19 vaccine in India, the two companies on Thursday said.
The approval by DCGI V.G. Somani marks the first such global trial for a foreign covid-19 vaccine to be conducted in India.
The global, randomised, double-blind Phase-III study will include more than 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America as well as from India.
The trial also aims to prevent symptomatic Covid-19 infections, as well as reduce severe disease and asymptomatic infection.
"India is participating in Sanofi Pasteur's pivotal Phase-III study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country," said Annapurna Das, Country Head, Sanofi Pasteur India, in a statement.
"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 programme. 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" she added.
In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain (D614), while a second stage will evaluate a second formulation targeting the Beta variant (B1351).
Recent scientific evidence shows that antibodies created against the Beta variant may provide broad crossprotection against other more transmissible variants.
Sanofi and GSK will also run clinical studies to assess the ability of the adjuvanted recombinant-protein Covid-19 vaccine candidate to generate a strong booster response regardless of the type of vaccine initially received.
The Phase 3 study initiation follows the global interim Phase 2 results which showed that the adjuvanted recombinant Covid-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups.
The French pharma company Sanofi and its British peer GSK aim to produce up to one billion doses in 2021.