“No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.” – Nuremberg Code
The ABVA (AIDS Bhedbhav Virodhi Andolan) views with serious concern the manner in which the alleged n-coronavirus vaccine in India is being launched for public use latest by 15 August, 2020. The topmost medical scientist at the Indian Council of Medical Research (ICMR) is forcing Phase I and II trials of this vaccine to be over by then. It is the most unscientific and dangerous way to proceed on with human trials. The speed with which the entire exercise has been surreptitiously undertaken is matched by the fast-tracking of Typhus vaccine in Nazi Germany, which had resulted in a disaster as Hitler’s very own German soldiers on whom the vaccine was used suffered tremendous morbidity and mortality. This happened because the vaccine was prepared with the Nazi SS men breathing down the necks of the medical scientists and with unpractical deadlines.
The canvassing for volunteers needed for the first two phases of the trial has started; about 1100 are needed in all. If the Government of India indeed feels that the vaccine is safe and efficacious for human trials to be started then why can’t it enlist all members of the present Lok Sabha & Rajya Sabha; Judges of the Supreme Court; Secretaries, Union Ministries & Chief Secretaries, States/Union Territories; Scientists at ICMR, AIIMS, NIV and Chair Persons, National Commissions who could voluntarily consent in writing to become subjects of the trials. Of course all of them will have to be explained the risks inherent in any clinical trial of a new drug; in case any mishap happens then compensation is already inbuilt in The New Drugs and Clinical Trials Rules, 2019.
However, if any one or all of them have reservations about being volunteer-subjects then an independent peoples’ commission should be constituted to ensure whether such a scheme as envisaged by ICMR is indeed scientific, safe and in consonance with the medical ethics as also WHO guidelines on vaccine trials.
Dr. P. S. Sahni & Shobha Aggarwal
Members, AIDS Bhedbhav Virodhi Andolan
Email: [email protected]
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