Clinical trials are extremely important to ensure safety, efficacy and efficiency levels of a vaccine, says K Sujatha Rao, former secretary in the Ministry of Health and Family welfare. The recent directions from Indian Council of Medical Research (ICMR) to all 12 trial sites for the Covid-19 vaccine candidate, Covaxin, to complete clinical trials by August 15, has kicked up a row. In an interview with Outlook's Preetha Nair, Rao warns that if norms are not followed, a bad vaccine can be ineffective and such reputation will end in people not buying it.
ICMR said that it aims to launch the world's first Covid-19 vaccine Covaxin by August 15, and asked 12 medical institutions to fast-track its clinical trial approvals. Do you think the timeline is a realistic one?
No. Not if all procedures are followed diligently and scrupulously as they are quite rigorous.
Randomised controlled clinical trials are considered to be the gold standard of vaccine tests. ICMR has asked the trial sites to fast track the process. How important are clinical trials to test the vaccine’s efficacy and safety?
They are extremely vital, as it is not enough to administer vaccines on humans without testing them on large samples to ensure safety, efficacy, and efficiency levels. And so important are these that the sample tests are phased out over 4 phases, each phase necessitating extensive and detailed documentation.
Last week, the World Health Organization (WHO) said that a vaccine may only be available in the next 12-18 months. This contradicts ICMR’s claim of the August 15 deadline. How challenging the task would be? Can vaccines be worked on pre-decided dates and deadlines?
No. Based on results obtained in Phase I and II trials, permission will be accorded for conducting the extremely critical Phase III. No one can predict results beforehand and so giving deadlines is futile.
Even globally, the front-runners in the development of Covid-19 vaccine have set a longer time-frame. The phase III trial of US’s top vaccine candidate Moderna is expected to begin only this month. In this scenario, will India be able to cover all the bases while developing the vaccine?
Medical experts say that in any vaccine trial, it’s the manufacturer who arranges the permission of the trial and the hospitals conduct the trial. Most of the 12 hospitals, which are selected for the trial, are not very well-known. Do you think the due process is being followed here?
I haven’t seen the list of the 12 hospitals. I do hope that good institutions with proven research capacity, excellent laboratories, and credibility for adhering to ethical norms and processes have been selected. This would be essential for the credibility of the vaccine and building public trust and confidence.
Experts also point out that there have been no such expedited vaccine trials like these in the last two decades. And if there is any lapse in process, what would be the potential risks?
Well, if there is any compromise in the quality of documentation, the company may not get the license to manufacture. Even assuming the Regulator is compromised in India, the company will never be able to qualify for export purposes and internationally India can lose credibility. But more importantly, a bad vaccine can harm or be ineffective and any such reputation will end in people not buying it.
Even if assuming that the vaccine is produced, who will evaluate the evidence? Normally, a vaccine is evaluated in terms of its evidence by the Drug Controller General of India (DCGI). What is ICMR’s role in this?
ICMR has no role in evaluating evidence or licensing. That comes under the Regulator's purview.
Many say that the hurried announcement should be seen in the backdrop of ‘vaccine nationalism’ and political compulsions. Your comments?
I hope not. It will be immensely unfortunate if political parties or political motivations or agendas are linked to the issue of vaccine production that is desperately needed by us all in the world. It is science and it should be just that.