Vaccine fixing: ICMR sets August 15 as deadline for developing anti-COVID-19 vaccine

With ‘Vaccine fixing’ ICMR has taken Indian medical research to uncharted depths of ignominy.

In a shocking letter sent by the Director General ICMR, Balram Bhargav to heads of 12 medical establishments, they have been directed to help develop a vaccine to deal with COVID-19 by August 15.

The letter states, “This is the first indigenous vaccine being developed by lndia ……... ICMR and BBIL (Bharat Biotech International Ltd.) are jointly working for the preclinical as well as clinical development of this vaccine. It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however final outcome will depend on the cooperation of all clinical trial sites involved in this project.”

It goes on to add, “You have been chosen as a clinical trial site of the BBV152 COVID vaccine. ln view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subiect enrolment is initiated no later than 7th July 2020.”

Lest there be any misgivings, a further sentence states – “Kindly note that non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse.”

Any doctor and scientist who has been trained to practice the science and art of medicine with a scientific temperament would be outraged by the exceptional audacity of the government which follows within days of ICMR having mixed fiction with the claimed results of its ‘seroprevalence’ study, in the quintessential sense of pseudo-science, for justifying government’s disastrous management of COVID pandemic.

If science really were to have its way, a Phase 3 vaccine efficacy trial would follow only after the safety and immunogenicity (the ability to invoke formation of antibodies against the pathogen) has been established through preclinical laboratory studies in tissue cultures or animals and then Phase 1 and 2 clinical trials to determine the safety of the vaccine and whether it produces the desired effect in the body.

Remarkably no data of pre-clinical or Phase 1 and Phase 2 trials of the purported vaccine has been put out in public realm.

The very fact that the commandment has been issued with the clearly stated objective of launching the vaccine “for public health use latest by 15th August 2020” implies that results are a foregone conclusion. The trial is only intended to impart a veneer of respectability.

Also remarkably, of the 12 institutes picked as trial sites, 8 are private institutes with as many as 6 being of the size of obscure nursing homes. Surprisingly, even though director AIIMS, New Delhi is a ‘distinguished’ pulmonologist, but the principal investigator from the institute is a professor of PSM, with no representation from the department of ‘Pulmonary medicine.’

One of the principal investigators is proprietor of one Prakar Hospital Pvt. Ltd., Kanpur, who it seems runs a business of conducting clinical trials. Clinical Trials Registry of ICMR mentions his name as a principal investigator for a trial of ‘Herbal Oil application in the prevention of mosquito bite.’

Another PI in Goa has no institutional affiliation. He is mentioned as located in Village Dhargal, Tal – Pernem on the Mumbai Goa Highway. Additionally, the dictat that the trial should start by 7th of July onward, is a clear signal for ethics to be thrown by the wayside, either by subverting or bypassing the process of ethical clearance all together.

AIIMS director Randeep Guleria termed the trial as a challenging task, while other have opined it as technically ‘impossible.’ Taking on challenges to make the impossible possible is an important task of science, but the question here is not of such ‘challenges’ or even the ‘technical propriety’; the question is of the very intent and mean politics that is fuelling such moves.

ICMR is a watchdog body for maintaining the standards of scientific research in India. But it seems the regulators have become the ‘regulated’ by their political masters. Between the proclamation by Vinod Paul, member NITI Aayog that the pandemic shall end in India by mid-May and the latest move of ICMR, a pattern of hubris fired by deceit and bigotry seems to have emerged that threatens greater undoing of science in the country.

Given such behaviour by leading scientific bodies one can hardly blame Baba Ramdev for his wont of making flabbergasting claims of his curative prowess every now and then. The difference is, while the Baba’s antics impact only his reputation, the misdoings of these scientific bodies lead to the undoing of the entire scientific establishment of the country. While the government may wish to add another defrauding feather to its ‘Atmnirbhar Bharat’ cap, there can be nothing more demoralising for India’s men and women of science.

It is disheartening to note that, some of the leading members of the profession have demeaned their own professional credibility and reputation to serve as willing instruments of those who currently occupy political power.

Rather than serving the cause of the people of India, these masters of scientific witchcraft have chosen to conspire against the very people they were to serve. It is time that such masters are sent packing. Their political benefactors certainly won’t do so. Its’ time that the larger scientific body speaks up lest their silence catches up with them sooner than later.

(Dr Vikas Bajpai is Assistant Professor, Centre for Social Medicine and Community Health, Jawaharlal Nehru University and Dr Harjit Bhatti is National President, Progressive Medicos and Scientists Forum)