Hyderabad: Russia’s Sputnik V trials at Dr Reddy’s

HYDERABAD: Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) has joined hands with Dr Reddy's Laboratories to conduct Phase III clinical trials for its Sputnik V Covid-19 vaccine in India and to distribute it in the country. TOI was the first to report recently that RDIF was in touch with companies in Hyderabad as part of its effort to access global markets for what is the world’s first registered Covid-19 vaccine.
Once Sputnik V gets regulatory approval in India, RDIF will supply 100 million doses to Dr Reddy’s for distribution.Deliveries are slated to begin by the end of the year but will be subject to completion of successful trials and its registration by Indian regulators, Dr Reddy’s Labs and RDIF said in a joint statement on Wednesday.
Post-registration clinical trials of 40k underway
According to the statement, post-registration clinical trials involving 40,000 volunteers are currently underway even as over 55,000 volunteers have applied for participation. The first results of the trials are expected to be published next month or in November.
Earlier this month, a research paper on the results of phase I and II clinical trials of Sputnik V were published in international journal The Lancet, stating that the vaccine demonstrated no serious adverse effects and had a stable immune response in 100% of participants.
RDIF and Dr Reddy’s said that the agreement reflects the growing awareness of countries and organisations to have a diversified anti-Covid-19 vaccine portfolio to protect their populations.
Dr Reddy’s co-chairman and managing director G V Prasad said the company will be conducting Phase-III trials in India to ensure the vaccine’s safety and efficacy for the Indian population and to meet the Indian regulatory requirements. “Phase I and II clinical trials of the vaccine have shown promising results. Sputnik V vaccine could provide a credible option in our fight against Covid-19 in India,” he said.
“India is among most severely impacted countries. 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. He added that they decided to partner with Dr Reddy’s as the company has a presence in Russia for the past 25 years.
Sputnik V, which has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the ministry of health of Russia on August 11, becoming the world’s first registered vaccine against Covid-19 based on the human adenoviral vectors platform.