Indian scientists say the August vaccine deadline - set by the country's medical council - is unrealistic
- 07 July 2020
The Bengaluru-based Indian Academy of Sciences has said that the Indian Council for Medical Research’s (ICMR) aim to launch a vaccine for the coronavirus infection by August 15 is simply “unfeasible” as well as “unrealistic”, APA reports citing the Hindustantimes.
Admitting that there is a crucial and urgent need for a vaccine to curb the spread of the disease, the body of scientists said that development of a vaccine for use on human beings needs scientifically done clinical trials conducted in a staggered manner.
“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.
It also referred to the ICMR’s letter which states that “it is envisaged to launch the vaccine for public health use latest by August 15th, 2020 after completion of all clinical trials”.
The Indian Council for Medical Research in collaboration with Bharat Biotech India Limited, a private pharma company, is jointly developing a vaccine against the coronavirus or Covid-19. A target of August 15 has been set by the ICMR for the launch of the vaccine in the country
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.
Looking at launching an indigenous Covid-19 vaccine by August 15, the ICMR had written to select medical institutions and facilities to fast-track clinical trial approvals for the vaccine candidate.
Health experts too have cautioned against hastening the process for developing a Covid-19 vaccine and stressed that it is not in keeping with 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. So, many ethical and regulatory approvals need to be obtained prior to starting the trials, it added.
The IASc cautioned 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 analyzed 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.