Russia’s sovereign wealth fund, the Russian Direct Investment Fund or RDIF, and global pharmaceutical company Dr Reddy’s Laboratories have agreed to collaborate on clinical trials and distribution of the Sputnik V vaccine in India, they said in a joint statement on Wednesday.
“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,” the statement from the RDIF and Dr Reddy’s read.
The RDIF will provide 100 million doses of the vaccine to Dr Reddy’s. The delivery of the Sputnik V, currently undergoing clinical trials, could potentially begin in late 2020 if the vaccine successfully passes trials and get a nod from the regulatory authorities in India, it added.
The pharmaceutical company will conduct the Phase III clinical trials of the vaccine in India, pending regulatory approval, according to the statement.
“We will be conducting [the] Phase III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian regulators,” GV Prasad, co-chairman and managing director of Dr. Reddy’s, said.
Professor Sergey Tsarenko, the deputy chief physician for anesthesiology and reanimation at a Moscow hospital, said that establishing the efficacy and safety of a vaccine was important. “In Sputnik V, safety is ensured by the use of human adenoviral vectors, which we repeatedly encounter throughout our lives,” he said. “Efficacy is achieved by using two different human adenoviruses sequentially, which differentiates this platform.”
Russia had on September 10 started inoculating volunteers with the “Sputnik V” vaccine against the coronavirus in Moscow, AFP reported
Moscow had rolled out the first batch of the vaccines for public use on September 8. The vaccine was found to produce an antibody response in all participants in early-stage trials, according to results published in the medical journal The Lancet on Friday.
Russia, which on August 11 announced that it has developed the world’s first coronavirus vaccine, had been criticised by scientists and experts for not conducting Phase 3 trials to determine its safety. A vaccine is deemed safe to be commercially available only after Phase 3 – a much larger efficacy trial involving thousands of participants. The advanced trial for the vaccine began on August 26. Russian Healthcare Minister Mikhail Murashko said on Wednesday that about 31,000 volunteers out of planned 40,000 have already been selected for the clinical trials, according to TASS.