The Russian COVID-19 vaccine Sputnik V will be tested on 100 volunteers in India, the Drug Controller General of India (DCGI) on Thursday told Sputnik.
DGCI had given permission to Dr Reddy's Laboratories, the pharma company that will supply the vaccine in the country, to conduct tests. However, the date and time of the test will be determined by the company.
Last week, an expert panel of the Central Drugs Standard Control Organisation (CDSCO) rejected a proposal by Dr Reddy's Laboratories to conduct large scale trials for Sputnik V in India. It had suggested that the Russian COVID-19 vaccine be first tested for safety and efficacy in a smaller trial.
Coronavirus vaccine Sputnik V, which is based on a human adenoviral vector platform with proven safety, is undergoing Phase 2 of clinical trials before moving on to Phase 3.
Dr Reddy's and Russian Direct Investment Fund (RDIF) have joined hands to carry out clinical trials and distribute 100 million doses of Sputnik V vaccine in India. A joint statement by the companies last month stated that deliveries of the vaccine could begin in late 2020, depending on the completion of trials and registration of the vaccine by regulatory authorities.
"Deliveries could potentially begin in late 2020, subject to completion of successful trials and registration of the vaccine by regulatory authorities in India," Dr. Reddy's said in a regulatory filing.
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Ministry of Health and became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Post-registration, clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020.
By Chitranjan Kumar