How will India deliver COVID-19 vaccine for "public health use" by 15 August 2020?

The news gives us tremendous hope that the Indian Council of Medical Research (ICMR) is aiming to introduce India's first indigenous vaccine against COVID-19 for "public health use" by 15 August 2020 (India's Independence Day). This could be a scientific breakthrough in the global fight against COVID-19. But a lot of questions remain unanswered regarding how we will deliver a safe and effective vaccine against COVID-19 in such a short time, given the reality that the enrolment for the phase-I clinical trial is yet to begin and the enrolment is to be done by 7 July 2020).

Noted infectious diseases expert Dr Ishwar Gilada, who is the President of AIDS Society of India (ASI) and Governing Council member of International AIDS Society (IAS), said that as per the news, there are two possible Indian vaccines against the COVID-19 under research and development. 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, 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 their final stages and the earliest possibility expressed by Oxford-Astra Zeneca group is December 2020, said Dr Ishwar Gilada.

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, added Dr Ishwar Gilada.

This vaccine's study design was registered on 1st July 2020 in the Clinical Trials Registry of India (CTRI), which is managed by ICMR and National Institute of Medical Sciences, Government of India. The study design shows that the duration of this study (for phases 1 and 2) is 15 months. Even if all goes well in phases 1 and 2 human clinical trials, it cannot 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 while phase-3 is in progress (like has happened for the anti-TB drug Bedaquiline). However, the ICMR letter says the vaccine will be made available for "public health use" by 15 August 2020 (in a record time of 40 days). It is anybody's guess as to 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 that study participants give their informed consent to participate and all their rights are well protected and respected. As per the CTRI online status of this study design on 4 July 2020, of the 12 institutional ethics committees approvals required, only 6 are marked "approved" and the status of the remaining is shown as "submitted/ under review".

Dr Ishwar Gilada rightly states that "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 could result in complacency in implementing 'what-we-know-works' in containing COVID-19, for example, infection prevention measures may take a backseat. 

Dr Gilada shares a leaf from the institutional memory: 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 and championing the pill as the best contraceptive for population control.

Dr Gilada said that "it is expected that the ICMR Director General 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."

4 July 2020

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