Sanofi, GSK get DCGI's nod for Phase 3 trial of Covid-19 vaccine
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New Delhi, July 08: The Drugs Controller General of India (DGCI) has granted approval to Sanofi and Glaxo Smith Kline (GSK) to conduct a Phase-III clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in India.
The pharma giants announced the news through social media account, In a press note, Sanofi said it has received a green signal for the Phase 3 trial in India to "assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein Covid-19 vaccine candidate".
According to the company, the 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 aims to prevent symptomatic Covid-19 infections, as well as reduce severe disease and asymptomatic infection."India
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Talking about the trials, Annapurna Das, Country Head, Sanofi Pasteur India said, "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."
"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 program 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). The company said that the recent scientific evidence shows that antibodies created against the Beta variant may provide broad cross-protection 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.
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