Jahnavi Sarma
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Written By: Jahnavi Sarma | Published : February 20, 2021 8:55 AM IST
Sputnik V is one of only three vaccines in the world with an efficacy of 91.6 per cent and has most authorizations granted with 26 countries globally.
India's vaccination drive is well under way. Two COVID-19 vaccines are approved for use in the country. One is Serum Institute of India's Covishield and the other is Bharat Biotech's Covaxin. Now, we may soon have a third option if things go according to plan. Pharma major Dr. Reddy's Laboratories Ltd on Friday announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V. This Russian vaccine is the first registered vaccine against COVID-19 in the world. As part of the review process, Dr. Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to conclude by February 21, according to the Hyderabad-based firm said. Dr. Reddy's had inked an agreement for partnership with the Russian Direct Investment Fund (RDIF) in September 2020. According to this agreement, Dr Reddy's will conduct the clinical trials of Sputnik V and get its distribution rights in India. At present, this vaccine is undergoing phase 3 clinical trial in India.
According to the interim results of the phase 3 trials, Sputnik V has an efficacy rate of 91.6 per. This trial included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine. This vaccine has maintained a consistent efficacy rate at 91.8 per cent even among the group of 2,144 volunteers who are over 60 years of age. The Lancet had also reported that the efficacy of this vaccine is 91.6 per cent. This is said to be an impressive development in the global fight against COVID-19. The initiation of the emergency use authorization process will be a critical step forward for Dr Reddy's in ensuring speedy access to the Sputnik V vaccine in India.
Sputnik V, which is developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020, became the world's first registered vaccine against COVID-19. This vaccine is based on the human adenoviral vector platform.
More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines. Sputnik V is one of only three vaccines in the world with an efficacy of 91.6 per cent and has most authorizations granted with 26 countries globally. The vaccine has already been administered to more than two million people worldwide.
(With inputs from IANS)
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