The letter dated 2 July 2020 by the Indian government’s apex medical research body ICMR (Indian Council of Medical Research) with a directive to begin and finish all human clinical trials of COVAXIN – an indigenously developed vaccine for COVID-19 – by 15 August 2020 (India’s Independence Day) so that the vaccine can be launched for “public health use” on that day (preceding midnight?), has raised critical questions about whether science has been compromised and/ or is on its way out of the window.
ICMR gave a clarification later that the letter was intended to cut red-tapism and avoid delays. But the burning question remains: Why did ICMR, knowing very well that it is fundamentally unethical to pre-determine research outcomes and also that it is principally impossible to do a robust clinical trial in 5-6 weeks, try to force researchers to begin and finish research and make a vaccine available for “public health use” by Independence Day? This letter stated that vaccine research is “being monitored at the topmost level of the government”. So, was it the Prime Minister’s Office that made such a demand with scant regard to science? Was it not the duty of ICMR to uphold the highest levels of science and integrity and decline such unjustifiable requests?
The news initially gave us tremendous hope that ICMR is working towards producing India’s first indigenous vaccine against COVID-19. But a lot of questions remain unanswered regarding how it will deliver a safe and effective vaccine against COVID-19 as early as 15 August 2020.
There is a scientifically validated and accepted protocol for conducting clinical trials to provide strong evidence on the safety, efficacy and effectiveness of the medicine, vaccine or any other medical product under study, before it can be put to public use. To ensure that the product under study is safe for humans (phase 1 study) and effective against a disease for the general populations and no harm to their health is caused by it (phases 2 and 3 studies), it is of utmost importance to adhere to all scientific and ethical considerations in the protocol and guidelines of the clinical trials.
As per the study design registered in CTRI (Clinical Trials Registry of India), the duration of this study (for phases 1 and 2) for COVAXIN is stated to be 1 year 3 months (15 months). In other words even if (and that is a big IF) all goes well in phases 1 and 2 human clinical trials, it will not be before September 2021 that we will learn if the vaccine is safe and effective, and ready to enter phase-3 (or for conditional roll-out like new anti-TB drug Bedaquiline while phase-3 study progresses ahead).
Human clinical trials have had a very bad history of abuses and human rights violations in the past century. That is why scientific protocols, guidelines and processes are well-established now worldwide to ensure that study/ trial participants give their informed consent to be part of the study, and all their rights are well protected and respected. We all want a vaccine at the earliest but it is equally important to ensure science is respected and all protocols and safeguards are in place so that neither the study participants nor the general population is harmed in any way.
The vaccine candidate COVAXIN has currently cleared only animal studies (or pre-clinical stage) and human clinical trials have yet to begin. This is a very initial stage and declaring a date for its “public health use” is assuming that the clinical trial outcomes will be positive, which is principally unethical for a scientific study. Such declarations will not only raise undue expectations but can also result in complacency in implementing ‘what-we-know-works’ (including prevention measures) in containing the spread of the virus.
In an interview, Dr Soumya Swaminathan, WHO Chief Scientist and former DG of ICMR, raised serious questions about this timeline (of 15 August 2020) and cautioned that speed may be important but could not come at the cost of scientific and ethical standards
If the ICMR is so confident of producing a vaccine within a month and a half why did it not announce such a measure in March itself so that the vaccine could have been developed at the earliest and saved much human suffering? The history of Indian medicine research is not very encouraging with only one Nobel prize in this field to Har Gobind Khorana for his research done in the United States when he had become US citizen.
Another important question is that though the strain of coronavirus was isolated by ICMR National Institute of Virology, then why is a government entity not doing further research and development of the vaccine? Why (as per the letter of ICMR) has it joined hands with a private biotech company (Bharat Biotech) for preclinical and clinical research development of the vaccine? If it is joint research of ICMR and Bharat Biotech then why is ONLY Bharat Biotech listed as the Principal Investigator, trial coordinator, primary sponsor (there is no other secondary sponsor), source of monetary or material support, scientific query lead, etc? If a private company (let’s say a soft drink company) is the only sponsor, funder, principal investigator etc of a research which shows the benefit of its product, then will we not call it junk science? Also, it is important to note that no ICMR institute is included in the list of the 12 centres of this multi-centric study. Instead, we see a host of private centres too. Why is ICMR not collaborating with only public healthcare institutions when it is the public healthcare centres that have been majorly managing COVID-19 and non-COVID-19 illnesses since the lockdown? Also, why has the government not leveraged the Epidemic Act to nationalize all health services including biotechs?
We should remember that right at the onset of lockdown in India, ICMR had landed itself in a controversy of negotiating a maximum price cap for the private sector for COVID-19 test which was way high, allowing the private sector to reap profits when the nation was reeling under a public health emergency and cascading humanitarian crisis. With this background, ICMR must come out clean on intellectual property and price negotiations, if at all the vaccine sees the light of the day. In addition to this, the government of India must fully support the proposal of the government of Costa Rica, for the development of a ‘global COVID-19 commons’ for all research, data, technology, treatments and vaccines relating to COVID-19 as a non-proprietary shared global resource.
While ensuring that there is no avoidable delay in scientific research, ICMR should not forget that it is also the vanguard for protecting the integrity of science and scientific rigour in the country.
In 2015 only 62% of newborn children received basic vaccinations in India. It is important to realize that vaccine-preventable illnesses are a significant cause of unnecessary human suffering and untimely deaths. We have failed to ensure zero-delay in making even the existing healthcare technologies (diagnostics, drugs, vaccines and other healthcare lifesaving procedures and care) available to everyone. While ICMR must ensure absolute adherence to all scientific norms and standards in conducting all research studies, the government also has to ensure that once these scientific breakthroughs come out of the research pipeline, they reach the people in need without any delay – where the ‘last person in the queue’, as per Mahatma Gandhi’s talisman, must come first.
Shobha Shukla, Bobby Ramakant, Sandeep Pandey
Shobha Shukla is the founding head of Citizen News Service, Sandeep Pandey is national Vice President of Socialist Party (India) and Bobby Ramakant is both with CNS and Socialist Party (India). Follow the authors on Twitter: @Shobha1Shukla, @Sandeep4Justice, @bobbyramakant
