ICMR aims to launch vaccine by Aug 15

Zydus also gets nod to start human trials for its COVID vaccine

NEW DELHI: India’s apex medical body, ICMR said Friday that it aims to launch the world’s first COVID-19 vaccine, the indigenously developed Covaxin, by August 15, and has told 12 medical institutions to fast-track its clinical trial approvals. But experts said such a timeline may not be realistic. The Indian Council of Medical Research (ICMR) has identified 12 clinical trial sites, including medical institutions and hospitals, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than July 7. The trial sites included AIIMS, New Delhi, AIIMS, Patna and SRM Medical College Hospital and Research Centre in Tamil Nadu.

COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech International Limited (BBIL) in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drug Controller General of India (DCGI). Separately, Zydus, which is part of Cadila Healthcare Ltd., in a statement on Friday said it has received approval from authorities to start human trials for its COVID-19 vaccine contender.

The vaccine candidate, ZyCoV-D, showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus said. In its letter to principal investigators of the 12 sites, ICMR Director General Dr Balram Bhargava noted that the clinical trial of Covaxin is one of the “top priority projects which is being monitored at the top-most level of the government”.

“It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project,” Bhargava said in the letter. However, it is not clear how the clinical trials can be completed and the vaccine released on August 15 when the normal period for a vaccine to be approved is 12 to 18 months.

Anant Bhan, of the Department of Forensic Medicine at Kasturba Medical College, Manipal, questioned the timeline of the announcement. “To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries. Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process,” Bhan wrote in a series of tweets. “For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on 07th July? And that the vaccine will be launched on 15th August? A vaccine trial completed in little over a month, efficacy pre-decided?”

In his letter to the 12 sites, ICMR chief Bhargava said: “You have been chosen as a clinical trial site of the BBV152 COVID vaccine. In view of the public health emergency due to COVID19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7.” Following a flurry of queries from the media about the authenticity of the letter dated July 2, ICMR spokesman Rajnikant Srivastava told PTI on Friday that “the letter is genuine and a request has been made to fast track the vaccine trials.” Even though the letter makes it seem as if the apex health research body plans to launch the vaccine by August 15, a scientist from the ICMR clarified that the aim of the letter is to fast track the human clinical trials of the vaccine so that results can come out early. “Only if the results are satisfactory only then can a vaccine be launched for public. It cannot be otherwise,” the scientist, who did not want to be named, said. The vaccine is derived from a strain of SARS-CoV2 isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the pre-clinical as well as clinical development of this vaccine, the letter said. Over seven vaccines are being researched in India and only Covaxin and Zydus’ ZyCoV-D have got the go-ahead to start human clinical trials, just this week. Globally, over 100 candidates are being tested on humans but no vaccine has yet been approved. (PTI

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