Indian pharmaceutical giant Dr. Reddy’s Laboratory Ltd. has partnered with Russia’s Direct Investment Fund (RDIF) to conduct phase III trials of the Russian Sputnik V vaccine and will distribute 10 crore doses of the coronavirus vaccine, a note. published by RDIF. said.
Pune-based Serum Institute of India and Hyderabad-based Biological-E are the other two Indian companies that have partnered with vaccine developers; Oxford-AstraZeneca and Janssen Pharmaceutica NV (“Janssen”), one of Johnson & Johnson’s Janssen pharmaceutical companies, respectively, for the domestic production of their vaccines.
The development in Dr. Reddy’s lab comes a week after the Indian government publicly confirmed that it was in advanced talks with the Russians for two reasons; production of the vaccine in India and phase III clinical trials of the same in the country.
Russia’s federal government had approved the Sputnik V vaccine emergency registry last month. The vaccine has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow. The Russian government’s prompt approval of the vaccine, even before the start of critical Phase III trials, was met with skepticism and criticism from scientists around the world.
However, the association between Dr. Reddy’s and RDIF is an indication that the vaccine will have to go through critical phase III trials to test its efficacy and safety in large numbers of people before it is approved by national 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 the conduct of the trials, according to the requirements of science and national regulations.
Dr. Reddy’s Lab Co-President and Managing Director GV Prasad said: “We are pleased to partner with RDIF to bring the vaccine to India. The results from phases I and II have shown promise, and we will conduct phase III trials in India to meet the requirements of Indian regulators. The 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 the completion of successful trials and registration of the vaccine by regulatory authorities in India,” the RDIF press release said.
“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 the countries most affected by COVID-19 and we believe that our vector platform Human adenovirus dual will provide a scientifically validated and safe option for India in the battle against COVID-19, ”said RDIF Executive Director Kirill Dmitriev.
.
