Will India Hoist Tricolour With Toast Of Covid-19 Vaccine?

Has ICMR Erred In Dictating 15 August Deadline For Its Public Use?

Mumbai : The national and international media is abuzz with two possible Indian vaccines against the COVID-19. The Drugs Controller General of India (DCGI) approved – COVAXIN of Hyderabad based Bharat Biotech and ZyCoV-D of Ahmedabad based Zydus Cadila for human clinical trials for their indigenously developed vaccine candidates against SARS-Cov-2, the virus that causes COVID-19. Going a step ahead the Indian Council of Medical Research (ICMR) Director General Dr. Balram Bhargava issued a Demi-Official (DO) letter; which was widely circulated, saying- India’s first indigenous vaccine against COVID-19 will be available for “public health use” by 15 August 2020. The global vaccine-war has over 110 independent scientific bodies in quest to find a potential COVID-19 preventive vaccine. None of them are in final stages and the earliest possibility expressed by Oxford-Astra Zeneca group is December 2020.
If successful, this could be the greatest scientific break-through in the global fight against COVID-19. If all three phases of clinical trials are completed in the record time of 40 days, then this will be the unique vaccine research and development globally. Let us take in all positive stride, keeping aside ‘science’. This will be one of the greatest leap forward by Indian Government and its ‘Make in India’ resolve. If all goes well as per Dr Bhargava’s diktats, we should ensure that:
1) The vaccine will be sold at affordable cost
2) The vaccine will be accessible by all in the length and breadth of the country as per systematic schedule
3) Senior citizens and people with co-morbidities (diabetes, hypertension, cancer, TB) will be prioritised
4) There will be fullest involvement private sectors/NGOs/social service organisations
5) There will be no exports till all Indians are vaccinated
Lots of questions remain unanswered regarding how we will deliver a safe and effective vaccine against COVID-19 by 15 August 2020, given the reality that the enrollment for the phase-I clinical trial has yet to begin and the enrollment is to be done by 7th July, 2020.After successful pre-clinical trial, human clinical trials provide gold standard scientific evidence on safety, efficacy and effectiveness of any medicine or vaccine or other medical products under study. However, there is a scientifically validated and accepted protocol for conducting clinical trials. To ensure that the product under study is safe for humans (phase 1) and effective against a disease for the general populations (phase –2 in ~ 500 people and phase –3 in ~ 5000 people) and does no harm to their health, it is of utmost importance to adhere to all scientific and ethical considerations in the protocol and guidelines of the clinical trial. The ICMR cannot be exception and in fact has to be extra strict being a regulatory body.This vaccine’s study design was registered on 1st July 2020 in the Clinical Trials Registry of India (CTRI, managed by ICMR and National Institute of Medical Sciences, Government of India). http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=45184&EncHid=&userName=vaccine
The study design shows duration of this study (for phases 1 and 2) to be 15 months. Even 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 the anti-TB drug Bedaquiline while phase-3 is in progress). But the ICMR letter says the vaccine will be made available for “public health use” by 15 August 2020. We wonder how this will be possible?
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 now well-established worldwide to ensure study participants are participating with full informed consent and all their rights are well protected and respected. As per the CTRI online status of this study design on 4 July 2020, only 6 out of 12 study centres have their ethics committees approved. Rest of the ethics committees are shows as “submitted/ under review”. Some of these seem to be small nursing homes/hospitals. The ICMR letter reads like a threat – “Get everything done by 07 July and start clinical trial participant recruitment”. Otherwise non-compliance will be viewed seriously. Thus the tone has a flavor of ‘action under the Epidemic Act’. Who will take action? We have never seen such tone earlier.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 participant nor the general population is harmed in any way. While ensuring there is no avoidable delay in scientific research, the ICMR should also be the vanguard for protecting the integrity of science and scientific rigour.COVAXIN has currently only finished animal studies and human clinical trials have not even begun yet. This is a very initial stage and declaring a date for its “public health use” is assuming the clinical trial outcomes like a match-fixing; which is bordering on being unethical for a scientific study. Such declarations raise undue expectations which may force infection prevention to take a backseat. It could also result in complacency in implementing ‘what-we-know-works’ in containing COVID-19 for example, prevention measures, etc.If India succeeds, it will be applauded globally and India as one of the most powerful countries that offered time-bound solution to prevent COVID-19 globally. Our worry is we should become a laughing stock, if we fail either in outcome or deadline. ICMR is not new to such controversies. During late 1980s ICMR DG Dr.A.S. Paintal had fallen from grace due to his controversial views on some health problems like – advocating a law to ban Indians from having sex with foreigners in order to curtail the spread of AIDS (when Mr. Rajiv Gandhi was the Prime Minister), and championing the pill as the best contraceptive for population control.It is expected that the ICMR DG will file a sworn affidavit with action plans including the Covid-19 vaccine before the Honourable Supreme Court when our application is scheduled to be heard in the Suo Motu Writ Petition on 20th July 2020.
Dr. Ishwar Gilada,
President AIDS Society of India and Governing Council Member, International AIDS Society
E-mail ID: [email protected]

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