Indian pharma giant Dr. Reddy’s Laboratory Ltd. has partnered with the Russian Direct Investment Fund (RDIF) to conduct phase-III trials of Russian vaccine Sputnik V and will distribute 10 crore doses of the anti-coronavirus vaccine, a press note released by RDIF said.
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 NV (“Janssen”), 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 VK 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 Lab co-chairman and managing mirector GV Prasad said, “We are pleased to partner with RDIF to bring the vaccine to India. Phase I and II results have shown promise, and we will be conducting phase-III trials in India to meet the requirements of Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID-19 in India.”
The Sputnik V vaccine is based on the human adenoviral vector platform and phase-III trials are underway in Russia. “Deliveries could potentially begin in late 2020, subject to completion of successful trials and registration of the vaccine by regulatory authorities in India,” the RDIF press note stated.
“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,” said RDIF CEO Kirill Dmitriev.