CEO Erez Israeli said the Dr. Reddy’s would begin phase II trials in the next few days and would complete phase III clinical trials of its Sputnik V COVID-19 vaccine by March end. The Dr. Reddy’s Labs would forward the vaccine for approval from the Drug Controller General of India (DCGI).
1,400 subjects for phase III, as compared to 100 participants for phase II trials.
Israeli said, “I hope we will finish phase II by December, which means not just the enrolment and the trial but also compilations of results,“
This vaccine works by mimicking COVID-19 infection and will quickly build herd immunity. SARS-CoV-2 virus is fairly stable which increases the viability of a vaccine because there are no bio-chemical modifications.
Vaccines need to be tested on healthy people s and also on children, pregnant women and the elderly separately. So rigorous testing is compulsory in this regard. It usually takes five or ten years to make a vaccine. Data from India will be complemented by the global clinical trial data of the vaccine.
The vaccine, Sputnik V, will be produced in India, at a third party site in Baddi. Sputnik V vaccine is based on a modified human adenovirus as vector, which carries the protein of the SARS-CoV-2 virus. RDIF says it will suppy 100 million doses to India.