Bengaluru-based prestigious Indian Academy of Sciences, on Sunday, took a strong objection to the letter written by the Indian Council of Medical Research (ICMR) that attempted to set a timeline to complete the clinical trials for the COVID vaccine candidate.
The vaccine candidate is developed by Hyderabad based Bharat Biotech company.
The ICMR has joined hands with the Bharat Biotech as it is going to be the first indigenous vaccine. But, the public sector scientific agency, which is the nation’s COVID monitoring body, has unrealistically exerted pressure on the 12 hospitals involved in the clinical trials.
In the July 2 letter, signed by its DG of ICMR, Balaram Bhargava, has almost set a deadline of 42 days to roll out the production of the vaccine. He asked hospitals to fast-track the trials or face the axe.
The Indian Academy of Sciences was set up by none other than Nobel Laureate Sir CV Raman in 1934 with the objective of promoting the progress and upholding the cause of science in the country. It has not been the practice in India for science academies to issues statements on the programs of government bodies like ICMR and their activities. So, the NASc’s statement issued on Sunday is being seen as an extraordinary step.
The Academy also clarified that it resorted to issuing the public statement as it thought that the announced timeline was unreasonable and without precedent.
The statement was issued by its president Partha P Majumder, a veteran Population Geneticist, who was the founder-director of the National Institute of Biomedical Genomics at Kalyani.
“Any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India,” the IASc said.
Referring to the Prof Balarama Bhargava’s letter to the doctors the Academy said while the development of an indigenous vaccine was welcome, the timeline set up by ICMR was simply unrealistic.
In his letter, Prof Bhargava wrote that the hospitals have to complete the volunteer recruitment process by July 7 and would have to accord the “highest priority” to the project as it was being monitored at the “topmost level in government” eyeing public launch on August 15.
The letter unusually ended with a threatening note. “Kindly note that non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on the highest priority and meet the given timelines without any lapse.”
The tone and tenor of the letter created a furor in the scientific community and many wondered as to how a nation’s premier scientific agency would try to dictate terms for a scientific process just because it is being monitored by those in the “topmost” levels.
Sensing the damage done by DG’s letter, the ICMR issued a clarification stating that the letter was meant to cut red tapes in the conducting trials.
“Just as the red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement. The aim is to complete these phases at the earliest so that population-based trials for efficacy could be initiated without delay,” said the clarification issued on July 4, 2020
The IASc, which has several scientists engaged in vaccine manufacturing, said the timeline has raised unrealistic hope and expectations in the minds of our citizens.
“while administrative approval can be expedited, the scientific processes of experimentation and data collection has a natural time span that cannot be hastened without compromising standards of scientific rigor. For example, the immune response usually takes several weeks to develop and relevant data should not be collected earlier,” the IASc said.
Moreover, data collected in one phase must be adequately analyzed before the next phase can be initiated.
If the data of any phase are unacceptable then the clinical trials are required to be aborted.
For example, if the data collected from phase 1 of the clinical trial show that the vaccine is not adequately safe, Phase 2 cannot be initiated and the candidate vaccine must be discarded.