Russia's COVID-19 vaccine Sputnik V makes headway in India
The Drug Controller General of India on October 17 gave Dr Reddy's Laboratories the permission to conduct late-stage clinical trials for Russia's COVID-19 Sputnik V vaccine in the country.
The nod came after the Hyderabad-based company submitted a reworked application to the Drugs Controller General of India (DCGI) on October 13 with more information on phase 2 and 3 trials.
Developed by Moscow’s Gamaleya Institute, the Russian Defence Ministry and the Russian Direct Investment Fund (RIDF), Sputnik V is based on a modified human adenovirus as the vector which carries the SARS-CoV-2 virus protein.
Also read: Gamaleya Institute's chief defends pace of Russian vaccination, says public-use of Sputnik V ethical
Dr Reddy’s trials will be a multi-centre and randomised controlled study on 1,500 volunteers and will include safety and immunogenicity study.
The same day, it was reported that Delhi-based Mankind Pharma had signed an agreement with the Russian Direct Investment Fund (RIDF) for the distribution and sale of Sputnik V in India.
The companies are yet to officially confirm the development that will make 300 million doses of Sputnik V available for distribution in India.
Sputnik, named after the world’s first satellite launched by the erstwhile Soviet Union, is now a top vaccine contender along with those of AstraZeneca-Serum Institute of India, Bharat Biotech and Zydus Cadila that are undergoing clinical trials.
In September, Dr Reddy’s and RDIF, which is marketing the vaccine overseas, entered into a partnership to conduct trials for Sputnik V and its distribution ...
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