Sputnik Light single-dose vaccine by Dr Reddy's launch in India may get delayed
image for illustrative purpose
The launch of Sputnik Light single-dose vaccine by Dr Reddy's in India may take some more time as the company will have to conduct Phase-3 immune-bridging clinical trials on the Indian population.
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has approved the company proposal to conduct the trials.
Sputnik Light is the first dose of Sputnik V vaccine, which uses the human adenovirus ad26 vector. A Dr Reddy's spokesperson declined to say when the trial will start.
The SEC asked Dr Reddy's to assess the primary endpoint at days 42, 90 and 180 and do an interim analysis at day 42 as this data was not generated during Sputnik V trial in India after the first dose, as this data was not generated during the Sputnik V trial in India after the first dose, as its duration was for 21 days.
The minutes of the 172 SEC meeting, which was held on August 8, said that Dr Reddy's presented the updated safety, immunogenicity and efficacy data of the Phase 3 clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct it in India.
