Dr Reddy’s, a global pharmaceutical company headquartered in India, has been granted approval by the Drug Controller General of India (DCGI) to conduct clinical trials of COVID19 vaccine Sputnik V.
Dr Reddy’s has been allowed to conduct phase 2 and 3 clinical human trials of the COVID19 vaccine made by Russia, according to media reports.
The health ministry of Russia in August said they started production of the first batch of vaccines against COVID19.
Russian President Vladimir Putin announced Sputnik V, which is named after the space satellite launched by Moscow in 1957, as the world’s first registered vaccine against COVID19.
The Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Limited on September 16 agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India.
Sputnik V, which is an adenovirus vector-based vaccine has been developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund.
The vaccine was registered on August 11.
“This is a significant development that allows us to commence the clinical trials in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic,” co-chairman and managing director of Dr Reddy’s Laboratories GV Prasad said in a statement.
“On regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic,” a statement issued by RDIF earlier said.
Earlier, it was reported that the DGCI declined the proposal of Dr Reddy’s Laboratories to conduct a large study of Russia’s Sputnik-V COVID-19 vaccine in India.
As per reports, the trials of Sputnik-V were conducted only on a small group of overseas population.
Moreover, many health experts raised concerns over the safety of the vaccine as it was rolled out within a short period of time even before large-scale trials were completed.
In September, Russian health minister Mikhail Murashko revealed that one in 7 volunteers complained of side effects, including weakness and muscle pain after taking Russia’s experimental COVID19 vaccine Sputnik V.
Union health minister Harsh Vardhan recently said the decision to conduct the third phase trial of Sputnik-V in India would be taken after much deliberation.