Experts recommends Dr Reddy’s for phase 2,3 clinical trial of Sputnik V

Elias Hubbard
October 17, 2020

"This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity study", said a joint statement issued by Dr Reddy's and Russian Direct Investment Fund (RDIF). The approval was given by the subject expert committee (SEC), that advises the drug regulator on clinical trials as well as drug and vaccine approvals, at its meeting held on Friday.

"We need to increase production of the first and second vaccine", he said in comments broadcast on state TV.

The Indian drug maker has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution. The vaccine, called "Sputnik V" in homage to the world's first satellite launched by the Soviet Union, is not yet in general circulation.

Russian Federation registered the new vaccine in August, before a large-scale Phase-3 clinical trial was conducted. On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russian Federation and became the worlds first registered vaccine against COVID-19 based on the human adenoviral vectors platform.

As part of the partnership, RDIF is set to supply 100 million doses of the vaccine to Dr Reddy's upon regulatory approval in India, IANS, an independent newswire, report said on Saturday.

Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine is also conducting phase 2 and phase 3 human clinical trials in India. But now DCGI has agreed to Dr Reddy's proposal. "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 from the Russian fund had earlier stated. The vaccine uses two adenovirus vectors (rAd26 and rAd5) against SARS-CoV-2 virus.

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