Indian Academy of Sciences pulls up ICMR for its Covid-19 vaccine rollout timeframe

Indian Academy of Sciences, a top science body in the country, on Sunday strongly criticised the Indian Council of Medical Research (ICMR) for setting up a target of 42 days to roll out the first indigenous Covid-19 vaccine from the preclinical stage.

Read: ICMR aims to launch indigenous Covid-19 vaccine by August 15

"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," IASc said in a press statement.

The Academy said it issued the public statement as it believed that the announced timeline was unreasonable and without precedent.

Also Read: ICMR's vaccine rush raises eyebrows

On behalf of the Academy, 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.

The statement from the Bengaluru-based Academy is unprecedented because science institutes in India rarely issue public statements criticising government efforts or scienctific agencies.

Read: ICMR issues clarification on 40-day target to roll out Covid-19 vaccine

Taking a note of the July 2 letter by the ICMR director general Balaram Bhargava to the doctors in 12 hospitals involved in the Covid-19 vaccine trial, the Academy said while development of an indigenous vaccine was welcome, the time-line set up by the ICMR was simply unrealistic.

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 that was being monitored at the “topmost level in government” eyeing a public launch on August 15.

A day later it issued a clarification saying that the letter was meant to cut red tapes and patient safety would be the council's priority.

"As a body of scientists – including many who are engaged in vaccine development – IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens," it said.

Also Read: Short timeline for India Covid-19 vaccine test raises doubts among health experts

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.

Also Read: Fast-tracking Covid-19 vaccine for PM Modi's announcement horrendous: Sitaram Yechury

"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," it said.

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.

Hyderabad-based Bharat Biotech manufactured the indigenous Covid-19 vaccine using a strain isolated by the National Institute of Virology, Pune.

IASc is one of the three leading science academies of India, the other two being Indian National Science Academy, Delhi and National Science Academy, Allahabad.