Russia’s Sputnik vaccine will be tested on 100 participants in India before proceeding for a larger trial, the Dr Reddy’s, the pharma company that will supply the vaccine in the country.
The Russian Direct Investment Fund , Moscow’s sovereign wealth fund, twith the Indian drug maker last month to supply 100 million doses of Sputnik V — the vaccine which has been found to produce an immune response with no serious adverse effects . in India after receiving the necessary regulatory clearances.
On Saturday, the company along with RDIF, announced that they have aproved from the Drug Control General of India (DCGI) to conduct phase 2 and 3 human clinical trials.
“The firm should generate safety and immunogenicity data on 100 subjects in Phase II clinical trial and submit for evaluation before proceeding to Phase III clinical trial,” the SEC decided in a meeting on 16 October.