DGCI grants approvals to Sanofi and Glaxo Smith Kline to conduct Phase-3 clinical study

French pharma major Sanofi mulls to conduct a part of the 35,000-participant global phase 3 trial in India for the covid vaccine it is developing with UK firm GlaxoSmithKline (GSK). The DGCI (Drugs Controller General of India) has granted approval to both the companies to conduct 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 on Thursday.

According to reports, 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 aims to prevent symptomatic Covid-19 infections, as well as reduce severe disease and asymptomatic infection.

Sanofi aims to prevent covid in unvaccinated adults who have not been infected earlier and also plans to conduct a parallel global study with various variant formulations to assess the ability of a lower dose to generate a strong booster response in people who have already received another vaccine.

The partnership between Sanofi and GSK is unprecedented in the global pharma industry. Sanofi 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.

 

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