Russia, Dr Reddy’s tie up for Sputnik V trial – Times of India

NEW DELHI: Russia’s sovereign wealth fund – Russian Direct Investment Fund (RDIF) — has partnered Hyderabad-based drug maker Dr Reddy’s Laboratories to cooperate on clinical trials and distribution of Sputnik V vaccine in India with deliveries for general use potentially beginning late this year.
Once regulatory approvals are in place for conducting trials in India, RDIF will supply 100 million doses of the Covid vaccine — developed by Russian researchers — to DRL. 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. The Indian Council of Medical Research (ICMR) maintains that Russia has a good track record in development of vaccines.
AstraZeneca or Oxford vaccine is also in Phase-3 trials with India’s Serum Institute contracted to produce it and has appeared ahead in the race for public use. There are two other Indian vaccines that are being developed and are in Phase I and II stage trials and have shown no significant side-effects yet.
Dr Reddy’s will perform Phase 3 clinical trials — where a vaccine is tested on thousands of human beings to establish efficacy and safety — for Sputnik V in India, as required by Indian regulatory norms.
RDIF said deliveries could potentially begin in late 2020, subject to completion of successful trials and registration of the vaccine by regulatory authorities in India. “The Phase I and II clinical trials have shown promising results. We will be conducting Phase-III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against Covid-19 in India,” DRL co-chairman & managing director G V Prasad said.
Sputnik V is an adenovirus vector-based vaccine that was registered by the Russian ministry of health on August 11. It is the world’s first registered Covid-19 vaccine. Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “We are very pleased to partner with Dr Reddy’s in India. 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 among 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. RDIF partners will receive an effective and safe drug to fight the coronavirus,” he added.
According to Dmitriev, the platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in over 250 clinical studies over decades, and it has been found safe with “no potential negative long-term consequences”. “The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organisations to have a diversified anti-Covid vaccine portfolio to protect their populations.”
While Russia and the Indian government have been in touch with several pharmaceutical companies in India for conducting clinical trials and manufacturing of the vaccine locally, Dr Reddy’s is the first to sign an official agreement with RDIF.