<p>Dr Reddy's Laboratories and Russian Direct Investment Fund (RDIF) on Tuesday said they have commenced adaptive phase 2/3 clinical trials for the Sputnik V Covid-19 vaccine in India.</p>.<p>The trials have commenced after receiving the necessary clearance from the Kasauli-based Central Drugs Laboratory, they added.</p>.<p><strong>Read | <a href="https://www.deccanherald.com/national/sii-trial-adverse-event-not-to-effect-covid-19-vaccine-timeline-govt-922120.html" target="_blank">SII trial 'adverse event' not to effect Covid-19 vaccine timeline: Govt</a></strong></p>.<p>This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study, the Hyderabad-based drugmaker and RDIF said in a joint statement.</p>.<p>The clinical trials are being conducted by JSS Medical Research as the clinical research partner.</p>.<p>Further, Dr Reddy's has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC's clinical trial centres for the vaccine, it added.</p>.<p>Recently, RDIF had announced the second interim analysis of clinical trial data, which showed 91.4 per cent efficacy for the vaccine on day 28 after the first dose; and efficacy of over 95 per cent 42 days after the first dose.</p>.<p>Currently, 40,000 volunteers are taking part in phase 3 of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose and more than 19,000 with both the first and second doses of the vaccine, it added. </p>.<p>"This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India.</p>.<p>"We are working towards making the vaccine available with a combination of import and indigenous production model," Dr Reddy's Laboratories Co-Chairman and Managing Director G V Prasad said.</p>.<p>In September 2020, Dr Reddy's and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.</p>.<p>Earlier on August 11, 2020, the Sputnik V vaccine, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia. It became the world's first registered vaccine against Covid-19 based on the human adenoviral vector platform.</p>
<p>Dr Reddy's Laboratories and Russian Direct Investment Fund (RDIF) on Tuesday said they have commenced adaptive phase 2/3 clinical trials for the Sputnik V Covid-19 vaccine in India.</p>.<p>The trials have commenced after receiving the necessary clearance from the Kasauli-based Central Drugs Laboratory, they added.</p>.<p><strong>Read | <a href="https://www.deccanherald.com/national/sii-trial-adverse-event-not-to-effect-covid-19-vaccine-timeline-govt-922120.html" target="_blank">SII trial 'adverse event' not to effect Covid-19 vaccine timeline: Govt</a></strong></p>.<p>This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study, the Hyderabad-based drugmaker and RDIF said in a joint statement.</p>.<p>The clinical trials are being conducted by JSS Medical Research as the clinical research partner.</p>.<p>Further, Dr Reddy's has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC's clinical trial centres for the vaccine, it added.</p>.<p>Recently, RDIF had announced the second interim analysis of clinical trial data, which showed 91.4 per cent efficacy for the vaccine on day 28 after the first dose; and efficacy of over 95 per cent 42 days after the first dose.</p>.<p>Currently, 40,000 volunteers are taking part in phase 3 of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose and more than 19,000 with both the first and second doses of the vaccine, it added. </p>.<p>"This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India.</p>.<p>"We are working towards making the vaccine available with a combination of import and indigenous production model," Dr Reddy's Laboratories Co-Chairman and Managing Director G V Prasad said.</p>.<p>In September 2020, Dr Reddy's and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.</p>.<p>Earlier on August 11, 2020, the Sputnik V vaccine, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia. It became the world's first registered vaccine against Covid-19 based on the human adenoviral vector platform.</p>