COVID-19: India declines proposal to test Russia's Sputnik-V vaccine in a large scale

The Drugs Controller General of India has denied permission to Dr Reddy's Laboratories Ltd to conduct large scale study in the country for testing Russia's Sputnik-V COVID-19 vaccine and asked it to first examine the vaccine in a smaller trial.

An expert panel of the Central Drugs Standard Control Organisation (CDSCO) remarked that safety and immunogenicity data from early-stage studies conducted overseas is small, with no inputs are available on Indian participants.

The Indian pharma giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V as well as its distribution. India's move comes as a setback for Russia's plan to roll-out the vaccine even before full trials prove its effectiveness. The decision pushes back its efforts to win approval for Sputnik-V in the country that leads the world on the average number of daily positive cases. India is expected to overtake the United States over the next several weeks with the world's largest number of cases.

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Coronavirus vaccine update

Russia was the first country to approve a vaccine for novel coronavirus even before large-scale trials were complete, raising concerns among scientists and doctors about the safety and efficacy of the shot. The phase-3 trial of Sputnik-V is underway in Russia since September 1 on around 40,000 subjects. The vaccine has been developed by Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF. 

Currently, two vaccine candidates, the indigenously developed by Bharat Biotech in collaboration with ICMR and the one developed by Zydus Cadila Ltd, are in phase 2 of human clinical trials. The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials in India. 

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India's COVID-19 cases top 68 Lakh

India saw a single-day rise of 78,524 COVID-19 cases taking the virus caseload to over 68 lakh, while the number of people who have recuperated surged to 58,27,704,  according to the Union Health Ministry data updated on Thursday. The national recovery stands at 85.25%

The total coronavirus cases mounted to  68,35,655, while the death toll climbed to  1,05,526  with 971 people succumbing to the disease in a span of 24 hours, the data updated at 8 am showed. The total recoveries have surged to  58,27,704 while there are 9,02,425 active cases of coronavirus infection in the country which comprises 13.20% of the total caseload, the data stated. The COVID-19 case fatality rate due to the coronavirus infection has dropped to 1.54%

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