While the world waits for the Covid-19 vaccine, on July 2 the Indian Council of Medical Research (ICMR) had stated that it may launch one by August 15. The ICMR claim had left the scientific community baffled at the proposed deadline, which is little over a month awaygo, many had called it unrealistic and near impossible. The Indian Express reported that this surprised even AIIMS Director Randeep Guleria, who heads the clinical research group of the national task force on COVID-19. “It will be a very challenging and difficult task, considering that we have to look at both efficacy and safety of any vaccine that is introduced. Also, if we get the desired results, the other challenge is the process of mass production of the vaccine,” Guleria told The Indian Express.
“I fear the global scientific community would be laughing at us for this. It should not have happened. India is a serious player in science. Who is going to trust us if we behave like this? Who is going to believe us even if we indeed come up with a good vaccine tomorrow?… And I am appalled at the kind of language used in the letter. It is not a letter, it reads like a threat,” Shaheed Jameel, virologist and chief executive of the Wellcome Trust-DBT Alliance that funds health research in India told IE, adding that the August 15 timeline was “ridiculous”.
In fact according to a report in the Hindu Business Line the ICMR announcement that the “vaccine for Covid-19 by Hyderabad-based Bharat Biotech International Ltd (BBIL) will be launched on Independence Day 15 has left the vaccine company and experts equally baffled.” According to the news report in the clinical trial protocol registered with the Clinical Trial Registry of India (CTRI), the BBIL has said the estimated duration of the trial is at least 15 months.
If this letter is genuine, then ICMR really has much to answer. Vaccines don’t work to threats and deadlines (not six week deadlines for sure) only because netas may like to do chest thumping on August 15. Please take medical science seriously ICMR/GOI. pic.twitter.com/7NOXhh4ztF
— Rajdeep Sardesai (@sardesairajdeep) July 3, 2020
However, hours after its announcement had come under criticism that it had perhaps ‘jumped the gun’ the ICMR issued a clarification on Saturday, July 4.
On Thursday, stated news reports, ICMR Director-General Balram Bhargava had written to 13 institutes — including AIIMS in New Delhi and Patna — that approvals and clinical trial processes need to be “fast tracked”, and that “non-compliance” would be viewed seriously. Volunteers for the clinical trial had to be enrolled latest by July 7, stated the ICMR.
“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?” Anant Bhan, a bio-ethics and policy Researcher-Bioethics raised many pertinent points on social media.
This is a letter which has been sent out by the ICMR DG yesterday. Now that multiple folks have confirmed genuineness, let me raise some issues with this letter on #vaccine #trials during a pandemic, in this case #COVID19
What are the ethical issues in this letter? Read on. pic.twitter.com/EaJkeaHjmV— Anant Bhan (@AnantBhan) July 3, 2020
The tone of the letter too was said to be objectionable: “It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials… 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, 2020,” Bhargava said in the letter, before sounding a warning. “Kindly note that non-compliance will be viewed very seriously.”
According to the IE report the approval for clinical trials had been given on June 29, and no one, not even the company itself, believes that the vaccine will be ready by August 15.
In a background note circulated the day it received approval for clinical trials, vaccine developer Bharat Biotech said that the results of Phase I and Phase II trials would be out only by October, stated IE.
The vaccine may still take some time to be freely available, but the ICMR clarification was quick. It stated that an “inactivated COVID-19 vaccine candidate has been developed by Bharat Biotech International ltd. in collaboration with ICMR – National institute of Virology, Pune.” And that the “ICMR is supporting the clinical development as the vaccine candidate appears to be promising, “and that the Drugs Controller General of India has permitted phase 1 and 2 clinical trials.”
It added that it was in the “larger public health interest,” for the clinical trials with a promising indigenous vaccine to be expedited. Adding that in the wake of the Covid-19 pandemic, “all other vaccine candidates across the globe have been similarly fast-tracked” and that “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.” According to the ICMR statement the “preclinical studies have been completed successfully, the phases 1 and 2 human trials are to be initiated.”
It goes on to clarify that the earlier letter by DG-ICMR “was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.” It stated that its aim was to “complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.”
The ICMR has reacted sharply to the criticism of its earlier claim and stated that it was “among the world’s most reputed organisations in the field of medical research and regulation” and its “trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB). While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of 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.”