DGCI approves Sanofi and GlaxoSmithKline to conduct Phase-3 clinical study

French pharma major Sanofi is developing with UK firm GlaxoSmithKline (GSK) to conduct a part of the 35,000-participant global Phase 3 trial for a COVID vaccine in India. DGCI (Drugs Controller General of India) has approved both the companies to conduct Phase-III clinical study to assess the safety, efficacy and immunogenicity of its adjuvant recombinant-protein COVID-19 vaccine candidate in India , the pharma giants announced on Thursday.

As per reports, the global, randomized, double-blind phase-III study will involve over 35,000 volunteers aged 18 years and above from the Americas, Asia, Africa and Latin America as well as India. The aim of the trial is to prevent symptomatic COVID-19 infection as well as reduce severe disease and asymptomatic infections.

Sanofi aims to prevent covid in uninfected adults who have not previously been infected and to conduct a parallel global study with a variety of formulations to assess the ability of low doses to produce a strong booster response in those are planning, who have already received another vaccine.

The partnership between Sanofi and GSK is unprecedented in the global pharma industry. Sanofi and its British partner began recruiting participants for their Phase 3 trial in the US in late May and plan to roll out the process in several countries in Asia, Africa and Latin America in the coming weeks.


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