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

Indian Acemy of Sciences, a Bengaluru-based body of scientists, has said Indian Council for Medical Research's (ICMR) target to launch a coronavirus vaccine by August 15 is "unfeasible" and "unrealistic".

IASc said while re is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.

While ministrative approvals can be expedited, "scientific processes of experimentation and data collection have a natural time span that cant be hastened without compromising standards of scientific rigour", IASc said in a statement.

In its statement, IASc referred to ICMR's letter which states that "it is envisd to launch vaccine for public health use latest by 15th August 2020 after completion of all clinical trials".

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

IASc welcomes exciting development of a candidate vaccine and wishes that vaccine is quickly me available for public use, statement said.

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

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

Experts have also cautioned against rushing process for developing a COVID-19 vaccine and stressed that it is t in accordance with globally accepted rms to fast-track vaccine development for diseases of pandemic potential.

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 require participation of healthy human volunteers. refore, many ethical and regulatory approvals need to be obtained prior to initiation of trials, it ded.

IASc said immune responses usually take several weeks to develop and relevant data should t be collected earlier.

"Moreover, data collected in one phase must be equately analysed before next phase can be initiated. If data of any phase are unacceptable n clinical trial is required to be immediately aborted," it said.

For example, if data collected from Phase 1 of clinical trial show that vaccine is t equately safe, n Phase 2 cant be initiated and candidate vaccine must be discarded.

For se reasons, Indian Acemy of Sciences believes that anunced timeline is "unreasonable and without precedent", statement said.

" Acemy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term verse impacts of unforeseen magnitude on citizens of India," it said.