COVID-19 Vaccine: DCGI allows Dr Reddy's Lab to conduct trials of Sputnik V

Drugs Controller General of India (DCGI) permitted Dr Reddy's Laboratories to conduct phase 2 and phase 3 clinical trials of Russia's COVID-19 vaccine Sputnik V. This came just days after DCGI denied permission to Dr Reddy's Laboratories for large scale study for testing Russian vaccine in India while asking it to examine Sputnik V in a smaller trial. Dr Reddy's Laboratories is collaborating with Russian Direct Investment Fund (RDIF) for trials and distribution of Sputnik V in India. 

DCGI permits Sputnik V trials

Earlier, Dr Reddy's lab submitted an application to DCGI seeking permission to conduct a phase 3 clinical human trials for Russian COVID-19 vaccine, Sputnik V. drugs regulator conducted a technical evaluation of application before giving permission to pharmaceutical company. According to officials, clinical trials of COVID-19 vaccine Sputnik V will be multi-centre, observer-blind and randomised controlled study and primary focus of study will be on safety and immugenicity of vaccine. According to ANI, Russia had promised to supply 100 million doses of Sputnik V to Dr Reddy's Laboratories after receiving approval from DCGI. RDIF CEO Kirill Dmitriev furr informed that Russia is in discussion with Indian government for localised production of Sputnik V in country. 

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Before India, Belarus and UAE gave approval for human trials of Sputnik V. Just a few days ago, UAE Ministry of Health and Prevention gave approval for Phase III clinical trials of Russian vaccine becoming second country after Belarus to take part in programme. trials will be supervised by Abu Dhabi Department of Health and UAE Ministry of Health and Prevention and medical protocols will be handled by a public health provider, Abu Dhabi Health Services Company. 

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In a statement CEO of RDIF said, "As part of Phase III trials of Sputnik V vaccine, we are planning to expand in several or countries over coming months, and we are delighted that UAE will be first country in which we do so in Middle East."

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Russia's COVID-19 vaccine Sputnik V 

COVID vaccine Sputnik V was developed by RDIF in collaboration with Gamaleya National Research Centre of Epidemiology and Microbiology. This vaccine became world's first registered vaccine against COVID-19 on August 11 and is currently undergoing phase 3 trials in Russia. Researchers suggest that Sputnik V is a human adeviral vector vaccine that fights against COVID-19 disease. results of phase I-II trials of Russia's vaccine were published by a medical journal Lancet. 

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(With inputs from ncies)