The Indian Academy of Sciences and the Breakthrough Science Society have issued statements asking the ICMR to follow strict protocols when it comes to the clinical trials.

Representative image of a hand holding a small bottle with a label saying COVID19 vaccinePicxy/Representative image
news Coronavirus Monday, July 06, 2020 - 15:06

The Indian Academy of Sciences (IASc), a Bengaluru-based body of scientists, has called the Indian Council for Medical Research’s target to launch a coronavirus vaccine by August 15 "unfeasible" and "unrealistic." The IASc said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.

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," the IASc said in a statement.

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

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 welcomes the exciting development of a candidate vaccine and wishes that the vaccine is 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 is 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 require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials, it added.

The IASc said the 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," 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 is "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.

Meanwhile, the Breakthrough Science Society (BSS) has also endorsed IASc’s statement and added that scientific enterprise needs to remain committed to strict protocols, abide by scientific methods, work towards public health ensuring safety and large-scale availability of the fruits of science to the common man.

“We urge upon the ICMR not to create false hopes regarding public release of the vaccine, and to heed to the opinion of experts in the field. We sincerely hope that the ICMR and the Health Ministry would take note of the serious concerns raised by the IASc as well as scientists and medical professionals at large, allow science to take its due course by following strict protocols, rectify its misleading deadline and instead, set both optimistic and realistic deadlines,” the BSS said in a statement. 

The science organisation also voiced concern about the article published by the Ministry of Science and Technology which had earlier mentioned that the vaccines may not be ready till 2021, but later deleted the sentence from the official release.

“It is reported that a Science Ministry Statement itself stated that the two vaccines developed in India, COVAXIN and ZyCov-D that have entered the stage of human trials, are not likely to be ready by 2021. But surprisingly, those words were deleted later with the claim that ‘the grammar of the sentence was wrong’. It is unconvincing that the content is deleted instead of correcting a grammar mistake. Further, the ex-ICMR chief NK Ganguly himself has stated that a good vaccine usually takes at least 18 months before its roll-out to production after fast-tracking all the mandatory regulatory approvals,” the BSS said.

Also read: Govt publishes article that said COVID-19 vaccine unlikely before 2021, then edits it

With PTI inputs