3 vaccines in clinical trial stage in India, IBS to start phase 3 trial soon: ICMR


The Indian Council for Medical Research (ICMR) said on Tuesday that three candidate vaccines against the coronavirus disease (Covid-19) are in the clinical stage of trials in India and one of them will soon begin Phase 3 trials after obtaining authorizations.

The Covid-19 vaccine candidates made by Cadila Healthcare and Bharat Biotech have completed the first phase of the trial, while the Serum Institute of India (SII) will start the phase 3 trial after obtaining approval, said Balram Bhargava, Director General of ICMR, during the information session of the Ministry of Health.

The Pune-based Serum Institute will carry out the phase 3 trial with 1,500 volunteers at 14 locations, Bhargava added.

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The ICMR statement comes a day after IBS said there won’t be enough vaccines to immunize everyone in the world by 2024. “It will take four to five years for everyone on this planet to receive the vaccine,” Adar Poonawalla, CEO of the Serum Institute of India, he had told the Financial Times.

Hours earlier, Health Minister Ashwini Choubey had informed the Lok Sabha that phase II clinical trials of Bharat Biotech and Cadila Healthcare are underway. He also informed the House that discussions on collaborations on the recombinant vaccine developed by Russia are ongoing. However, no formal studies have been initiated.

On the association of IBS and ICMR for the clinical development of two global candidate vaccines, Choubey said, the first is ChAdOx1-S, a non-replicating viral vector vaccine developed by the University of Oxford and AstraZeneca. This vaccine is in phase 3 clinical trials in Brazil. She added that the ICMR has initiated phase 2/3 bridging studies at 14 clinical trial sites. The ICMR-National Institute for Tuberculosis Research, Chennai is the leading institution.

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He also told the lower house of Parliament that testing of the second candidate vaccine being clinically developing ICMR and IBS will begin in the second half of October after the US Novavax vaccine is manufactured by the company with headquarters in Pune. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune, he said.

The Union Health Minister Harsh Vardhan had said last week that a vaccine could be ready by the first quarter of 2021.

India’s Covid-19 count will approach the grim milestone of five million cases, while the toll from the viral disease has surpassed 80,000.

(With contributions from the agency)

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