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According to the Indian Academy of Sciences, the aim of the Indian Council of Medical Research to launch the Covid-19 vaccine on August 15 is simply “unfeasible” and “unrealistic,” as per media reports.
“Administrative approvals can be expedited, but 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 on Monday.
The Bengaluru-based institute admitted that the need for the vaccine at this stage is urgent and dire. However, the development of a vaccine for use on human beings needs scientifically-done clinical trials conducted in a sequential manner.
The IASc also referred to the ICMR’s letter, which stated: “It is envisaged to launch the vaccine for public health use latest by August 15th, 2020 after completion of all clinical trials”.
Though the scientists’ body has welcomed the development of a candidate vaccine, it feels that the idea is “unrealistic”, 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 hopes and expectations in the minds of our people,” the statement read.
The vaccine against Covid-19 is being jointly developed by The ICMR and the Bharat Biotech India Limited, a private pharma company.
The ICMR had also written to high-profile medical institutions and facilities to fast-track clinical trial approvals for the vaccine candidate so that the institution can launch the indigenous vaccine on India’s Independence Day.
Phased trials needed
The IASc said trials for a vaccine involve evaluation of safety (Phase 1), efficacy and side effects at different dose levels (Phase 2), and confirmation of safety and efficacy in thousands of healthy people (Phase 3), before it can be released for public use.
Clinical trials for a candidate vaccine require participation of healthy human volunteers. So, many ethical and regulatory approvals need to be obtained prior to starting the trials, it added.
The IASc noted that the immune responses usually take weeks to develop and relevant data should not be collected in a hustle.
“Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase is unacceptable then the clinical trial is required to be immediately aborted,” it said.
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