COVID-19 vaccine candidates being developed by Cadila Healthcare and Bharat Biotech have completed the phase one of the study while Pune-based Serum Institute of India (SII) will begin with Phase 3 clinical trial after getting regulatory nod, says ICMR chief
The Indian Council of Medical Research (ICMR) on Tuesday said three potential COVID-19 vaccines are in different phases of the clinical study, while one of them is set to begin phase 3 trials after getting regulatory nod.
COVID-19 vaccine candidates being developed by Cadila Healthcare and Bharat Biotech have completed the phase one of the study while Pune-based Serum Institute of India (SII) will begin with Phase 3 clinical trial after getting the nod, said Balram Bhargava, ICMR's director general, while addressing the media as part of the Health Ministry's briefing in Delhi.
Covaxin, which is being developed by Hyderabad-based Biotech International Limited in collaboration with the ICMR, is touted as India's first indigenous COVID-19 vaccine. In July, Bharat Biotech had started clinical trials for Covaxin on 1,125 patients at 12 hospitals across the country including All India Institute of Medical Sciences in Delhi. The company is yet to announce when it will launch the vaccine, though Bharat Biotech's CMD Krishna Ella had said that to ensure safety and efficacy it would not expedite the vaccine with short-cuts.
Similarly, Zydus Cadila's ZyCoV-D COVID vaccine, which has successfully cleared the first phase of clinical trials, has entered second phase of the study. While the second phase of human clinical trials, involving 1,000 volunteers, begun on August 6, the vaccine is targeted to hit markets by early next year. The vaccine, using the platform of plasmid DNA, was found to be safe and well-tolerated in the Phase I, which began on 15 July, said Zydus Cadila.
Serum Institute's 'Covishield' has received approval from the Drugs Controller General of India (DCGI) to conduct phase 2 and phase 3 clinical study in the country.
The ICMR chief said that Serum Institute vaccine candidate will conduct the phase 3 trial on 1,500 volunteers across 14 locations, Bhargava added.
Earlier on Monday, Adar Poonawalla, CEO of Serum Institute (SII), said there won't be enough vaccines to combat the novel coronavirus for everyone in the world till 2024. "It's going to take four to five years until everyone gets the vaccine on this planet," he told the Financial Times.
Last week, Union Health Minister Harsh Vardhan had said that even though no date was fixed for launching the coronavirus vaccine, it may be ready by first quarter of 2021.
By Chitranjan Kumar