After striking down the first proposal, the Drug Controller General of India has finally allowed Dr Reddy’s to conduct phase 2/3 clinical human trial of Sputnik V, the COVID-19 vaccine that makes Russia the first country to have come up with a vaccine. Since Sputnik V was tested on a small number of people in Russia before it got registered as a vaccine, the DCGI raised questions over DR Reddy’s initial proposal of testing it among a bigger population in India. At present, Sputnik V is currently undergoing post-registration phase 3 clinical trial engaging 40,000 participants. In September, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, India will get 100 million doses of Sputnik. Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval, Health Minister Dr Harsh Vardhan said on October 18. Vardhan said the late-stage trial generally involves thousands of participants, sometimes 30,000 to 40,000. India will get 60-70 million doses of Oxford vaccine Covishield by December but the vaccines will come to the market in March 2021, Pune’s Serum Institute of India (SII) has said revealing its latest updates on the ongoing trial of AstraZeneca-Oxford vaccine. Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO). The number of cases in the country now stand at 75,50,273. In the 24-hour period, India, which is the second worst-hit country, reported 579 deaths linked to the COVID-19, taking the total number of fatalities to 1,14,610.
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