New Delhi:
After medical experts cautioned against rushing a COVID-19 vaccine, the ICMR on Saturday defended its move to fast-track clinical trials for a planned launch by August 15, saying the process was exactly in accordance with globally accepted norms. The premier medical research body said the letter by its Director-General Dr Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.
“Trials will be done following the best practices and rigour,” the Indian Council for Medical Research(ICMR) said in a statement, seeking to address concerns voiced by several experts who said the timeline set by the research body may not be realistic. “ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.” The statement further said that in the larger public health interest, it is important for the ICMR to expedite the clinical trials with a promising indigenous vaccine, adding it is committed to treating the safety and interest of people of India as a topmost priority.
“While issues raised in the public domain from time-to-time by commentators are welcome, as they form an important part of the feedback loop, the best of India’s medical professionals and research scientists should not be second-guessed for their professionalism or adherence to the highest scientific rigour.” Bhargava had on July 2 written to principal investigators of select medical institutions and hospitals to fast-track human clinical trial approvals for the vaccine candidate ‘Covaxin’ being developed in collaboration with Bharat Biotech International Limited(BBIL). Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of the normal life, all other vaccine candidates across the globe have been similarly fast-tracked, the ICMR statement said.
The Drugs Controller General of India has accorded permission to conduct phase 1 and 2 (human) clinical trial of ‘Covaxin’ based on in-depth scrutiny of the available data from pre-clinical studies, it added. Just as the red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement, it said.
“The aim is to complete these phases at the earliest so that population-based trials for efficacy could be initiated without delay.” After intense characterization and review of all data from BBIL, ICMR said it is supporting the clinical development as the vaccine candidate appears to be promising. Separately, Zydus, which is part of Cadila Healthcare Ltd., has said it has received approval from authorities to start human trials for its COVID-19 vaccine contender.
Underlining that ICMR was among the world’s most reputed organisations in the field of medical research and its track record of facilitating India’s globally respected and acknowledged vaccine and drug industry speaks for itself, the research body said trials will be reviewed, as required, by a Data Safety Monitoring Board (DSMB). Anant Bhan, of the Department of Forensic Medicine at Kasturba Medical College, Manipal, among others had 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. Virologist Upasana Ray noted while an accelerated launch or promise for launch for a vaccine against novel coronavirus deserves applause, we also have to think if we are rushing too much.
“We must rush albeit carefully. Giving this project high priority is absolutely important. However, excess pressure might not necessarily lead to a positive product for public use,” Ray, senior scientist at CSIR-IICB, Kolkata, told PTI. The ICMR statement came on a day when India’s COVID-19 tally neared 6.5 lakh cases with a record single-day spike of 22,771 new infections.
While the caseload climbed to 6,48,315, the death toll rose to 18,655 with 442 new fatalities, according to the Union Health Ministry data. The 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.
Noting that this was the first indigenous vaccine being developed by India, Bhargava in his letter to principal investigators of the 12 sites said that it 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…
“You have been chosen as a clinical trial site of the BBV152 COVID vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7,” the letter stated. The letter further warned that any non-compliance will be viewed very seriously.
“Kindly note non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on the highest priority and meet the given timelines without any lapse,” the letter stated.
