India’s apex drug regulator is likely to take up Serum Institute of India’s (SII) request to start human trials for AstraZeneca and the University of Oxford’s COVID-19 vaccine candidate in India in the first half of the week, The Indian Express has learnt.
On Saturday, the Pune-headquartered firm approached the Central Drugs Standard Control Organisation (CDSCO) with its application to conduct late stage clinical trials for the vaccine candidate, said a senior government official in the know. The Subject Expert Committee (SEC) for COVID-19 related proposals may meet on the matter Tuesday or Wednesday, the official added. If the SEC approves the application, SII will be able to conduct trials on thousands of Indian participants in August to test the safety and effectiveness of the vaccine candidate.
When contacted, the institute’s CEO Adar Poonawalla declined to comment on the development. SII has a tie up with Swedish-British pharmaceutical company AstraZeneca to manufacture at least a billion doses of this vaccine for low- and middle-income countries.
Last Monday, encouraging preliminary data from early stage trials of the vaccine candidate, developed by University of Oxford in collaboration with AstraZeneca, was published in the Lancet medical journal. Poonawalla said at that time that SII would approach CDSCO for approval to conduct licensure trials the following week.
He had also told The Indian Express earlier that the firm intended to conduct these phase III trials on around 5,000 participants in hotspot cities like Mumbai and Pune, as it would give the firm a better idea of the effectiveness of the vaccine candidate.
“With the government fast tracking everything, we are hoping to get approvals soon, post which we will begin Phase III human trials in India around August. For the phase III trials, we plan to have 4,000-5,000 people in India.
“Based on the success of the trials, we are hoping to have the vaccine by the end of this year. However, it will start reaching out to masses properly by the first quarter of the next year,” Poonawalla said. SII intends to manufacture around 60-70 million doses a month of the vaccine, which it is calling Covishield, and plans to manufacture around 300-400 million doses by the year’s end.
Based on Serum’s agreement with AstraZeneca, the firm will be distributing 50 per cent of the vaccine to India, while the remaining will be given to GAVI countries.
📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines