Dr Reddy’s, RDIF get drug DGCI nod to conduct clinical trials of Sputnik V vaccine in India

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Last month, RDIF and Dr Reddy’s Laboratories agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India

Pharma major Dr Reddy’s Laboratories and Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) reportedly received the India’s drug regulator’s nod for conducting late-stage clinical trials of the COVID-19 vaccine in the country, said a news report.

Dr Reddy’s announced that they the Drug Control General of India’s (DCGI) nod to conduct late-stage clinical trials for Sputnik V vaccine in India.

The clinical trials will be a multicenter and randomised controlled study, which will include safety and immunogenicity study, said a report in Mint.

“This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic," GV Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories was quoted as saying in the report on the development.

Last month, RDIF and Dr Reddy’s Laboratories agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India.

Upon 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.

RDIF reportedly reached pact with Indian manufacturers to produce 300 million doses of the vaccine.

Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

On August 11 this year, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform.

On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100 percent of participants. 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.

Image credit: The Print

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