Covid-19 vaccine controversy: Letter issued to cut unnecessary red tape, says ICMR

The Indian Council of Medical Research (ICMR) has stated that it had issued the contentious letter to participating institutes in Covid-19 vaccine trials for envisaging a vaccine launch by August 15 this year, with an intention to cut ‘unnecessary red tape’.

“The letter by Director General of ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any unnecessary process and speed up recruitment of participants,” said a press statement issued by ICMR. “The indigenous vaccine development process has 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,” the statement further says.

After the letter was issued, ICMR had faced much criticism for announcing a potential vaccine launch against Covid-19 within close to a month, while the Hyderabad-based vaccine company Bharat Biotech was yet in pre-clinical stages of vaccine development. Experts pointed out that it was impossible to conduct human trials in Phase 1 and two within a month, and the company has said that these trials will take at least over a year.

The ICMR press statement does not attribute any reason for pegging a premature vaccine launch date of August 15.

Amidst the debate of haste for vaccine launch, India recorded 6,73,165 Covid-19 cases, of which the Ministry of Health has said that 4,09,083 (up to 60 per cent) have recovered while another 19,268 persons have died.

‘Unfeasible timeline’

Meanwhile, Indian Academy of Sciences has issued a statement against ICMR’s announcement to make a vaccine available by August 15. “As a body of scientists – including many who are engaged in vaccine development – Indian Academy of Sciences (IASc) strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens,” it states.

“While there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner. These trials involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial) and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use. Clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials,” said Partha P Majumder, President, IASc.

He further said, “While administrative approvals can be expedited, the scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour. For example, immune responses usually take several weeks to develop and relevant data should not be collected earlier. Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase are unacceptable then the clinical trial is required to be immediately aborted. For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 cannot be initiated and the candidate vaccine must be discarded.”