Sanofi-GSK Covid-19 vaccine gets nod to start phase-3 trials in India

India part of 35,000 volunteer global efficacy trial

French pharmaceutical giant Sanofi and its British partner GlaxoSmithKline (GSK) plc have received approval from the Drugs Controller General of India (DCGI) to conduct a part of the global Phase 3 efficacy trial of their jointly developed Covid vaccine in India.

 The approval by DCGI marks the first such global trial for a foreign Covid vaccine to be conducted in India — the enrolments are expected to begin soon.

India will be part of the global randomised, double-blind Phase 3 study to assess the safety, efficacy, and immunogenicity of their vaccine. This will include more than 35,000 adult volunteers across the US,