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,