The Winning Shot. Dr. Reddy's Join Hands with Russia's RDIF for Coronavirus Vaccine Sputnik V Trial in India


The Winning Shot. Dr. Reddy's Join Hands with Russia's RDIF for Coronavirus Vaccine Sputnik V Trial in India

Dr. Reddy’s Laboratory Ltd., the Indian pharma giant has partnered with Russia’s sovereign wealth fund - Russian Direct Investment Fund (RDIF) to conduct phase-III trials of Russian vaccine Sputnik V. Once regulatory approvals are in place for conducting trials in India, RDIF will distribute 10 crore doses of the anti-coronavirus vaccine, a press note released by RDIF said. The results of the early phases (Phase 1 and 2) of trials with the vaccine were recently published in Lancet, while both India and Russia were in talks to pursue further trials and manufacture of the vaccine in India. “We are pleased to partner with RDIF to bring the vaccine to India. The Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India,” asserted G. V. Prasad, Co-Chairman and Managing Director, Dr Reddy’s, in a statement.

The Indian Council of Medical Research (ICMR) maintains that Russia has a good track record in development of vaccines. “The Sputnik V vaccine based on the adenoviral vector platform, will be available in India as early as November this year, if the trials succeed,” stated Kirill Dmitriev, CEO of RDIF. RDIF is also in talks with four other Indian manufacturers who will be producing these vaccines for India. “The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations”, said a statement from the fund.

Pune-based Serum Institute of India and Hyderabad-based Biological-E are the two other Indian companies that have tied up with vaccine developers; Oxford-AstraZeneca and Janssen Pharmaceutica N.V., one of the Janssen Pharmaceutical companies of Johnson & Johnson, respectively, for domestic production of their vaccines. The development at Dr. Reddy’s Lab comes a week after the Indian government publicly confirmed that it was in advanced talks with the Russians on two counts; production of the vaccine in India and conducting Phase-III clinical trials of the same in the country.

Russia’s federal government had approved emergency registration of the Sputnik V vaccine last month. The vaccine has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow. The Russian government’s early approval for the vaccine, even before the commencement of the critical Phase-III trials, was met with skepticism and criticism from scientists around the world.

However, the partnership between Dr. Reddy’s and RDIF is an indication that the vaccine will have to go through the critical phase-III trials to test for efficacy and safety on a large number of people before it is approved by domestic regulators. Dr V.K. Paul, Head of the National Covid-19 Task Force, had said last week that there would be phase-III trials in the normal course of things and that the government was also facilitating conduct of the trials, according to requirements of science and domestic regulations.

“Dr. Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is amongst the most severely impacted countries from COVID-19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID-19,” Kirill Dmitriev.