The search for a COVID-19 vaccine is well underway in India. However, the Indian Council of Medical Research (ICMR) has sparked controversy with what some experts have suggested are dubious claims.
The ICMR announced last week that an indigenously-manufactured vaccine may be ready by mid-August. ICMR Director-General Dr Balram Bhargava said “it is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials. Bharat Biotech is working expeditiously to meet the target. However, the final outcome will depend on the cooperation of all clinical trial sites involved.” The letter was addressed to twelve institutes earmarked as clinical trial sites for the COVID-19 vaccine trials.
The prospective vaccine is Covaxin, being developed by Bharat Biotech in collaboration with the National Institute of Virology (an ICMR body). “The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility,” Bharat explains on its website. “The vaccine received DCGI [Drug Controller General of India] approval for Phase I & II Human Clinical Trials and the trials will commence across India from July, 2020.” Reports indicate that more 1,100 people are anticipated to be enrolled for Covaxin trials.
Of the 140 global COVID-19 vaccine candidates, eleven are beginning the human trial phase including two from India (Covaxin and ZyCov-D vaccine, produced by the Cadila Healthcare Ltd.-owned Zydus).
However, the prospective timeline for “public health use” of the COVID-19 vaccine candidate has been questioned by commentators. In a statement, the Indian Academy of Sciences (IASc) warned against “any hasty solution that may compromise rigorous scientific processes and standards.” The statement outlined that “IASc welcomes the exciting development of a candidate vaccine and wishes that the vaccine is quickly made available for public use. However, as a body of scientists-including many who are engaged in vaccine development-IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens.”
The IASc asserted that “clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the indication of the trials. While administrative approvals can be expedited, the scientific process of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour.”
It has been pointed out that a Ministry of Science and Technology release earlier said “now with the nod given by the Drug Controller General of India CDSCO (the Central Drugs Standard Control Organisation) for the conduct of the human trial, it will take anywhere between fifteen to eighteen months before licence are issued for the vaccines. Nonetheless this marks the beginning of the end.” This line has since been redacted from the version published by the Press Information Bureau, as was a line that said that vaccine candidates would not be ready before 2021, per a report published by The Wire.
The announcement has dampened the credibility of the ICMR, suggest experts cited by The Hindustan Times. “It is good to be ambitious and aspirational but it should not be done at the cost of due diligence for ensuring the safety and efficacy of the vaccine,” said K. Sujatha Rao, a former secretary in the Union Ministry of Health and Family Welfare. “I would like to believe that it is a typographical error of saying 2020, instead of 2021. If not, the implications are serious as the proposed vaccine can only be ready by August 15 by fudging data or incomplete documentation. There is no other way.”
Rao tweeted that “someone should brief [the Director-General of the] ICMR about the processes involved in comming [sic] out with a vaccine…which magic wand does ICMR have to produce it in six weeks?”
The Hindustan Times also quotes virologist Dr T. Jacob John, formerly a professor at Vellore’s Christian Medical College, who said “it has lowered the credibility of ICMR, and along with that of India’s scientific community, regulatory system government, and the potential vaccine… its reputation is dented before it is even ready…ICMR should, like Caesar’s wife, not just be above reproach but should also be perceived as infallible. That reputation has taken a beating.”
WHO Deputy Director-General and Bhagrava’s predecessor as ICMR Director-General Dr Soumya Swaminathan also raised concerns about the proposed timeline in an interview with The Wire.
For its part, the ICMR has sought to clarify its statement in the wake of the controversy. It has said that August 15th does not represent a deadline, but rather an indication that the process would be expedited in accordance with global norms.
“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine,” read an ICMR statement. “Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of…normal life, all other vaccine candidates across the globe have been similarly fast-tracked.
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…just as 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. The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.”