Aug 15 target for COVID-19 vaccine launch ‘unfeasible’: Indian Academy of Sciences

New Delhi, July 6

The Indian Academy of Sciences (IASc), a Bengaluru-based body of scientists, has said the Indian Council for Medical Research’s (ICMR) target to launch a coronavirus vaccine by August 15 is “unfeasible” and “unrealistic”.

The IASc said while there was an unquestioned urgent need, vaccine development for use in humans required scientifically executed clinical trials in a phased manner.

While the administrative approvals could 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”, the IASc said in a statement.

In its statement, the IASc referred to the ICMR’s letter which states: “It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trial.”

The ICMR and Bharat Biotech India Limited, a private pharmaceutical company, are jointly developing the vaccine against the novel coronavirus — SARS-CoV-2.

The IASc welcomed the exciting development of a candidate vaccine and wished that the vaccine was quickly made available for public use, the statement said.

“However, 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.

Aiming to launch an indigenous COVID-19 vaccine by August 15, the ICMR had written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate, COVAXIN.

Experts have also cautioned against rushing the process for developing a COVID-19 vaccine and stressed that it was not in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.

The IASc said: “Trials for a vaccine 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 required the participation of healthy human volunteers. Therefore, many ethical and regulatory approvals needed to be obtained prior to the initiation of the trials, it added.

The IASc said the immune responses usually took 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,” it said.

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.

For these reasons, the Indian Academy of Sciences believes that the announced timeline was “unreasonable and without precedent”, the statement said.

“The Academy strongly believes that 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,” it said. PTI