New Delhi, Jul 6: The Indian Academy of Sciences, 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 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.
Comments
Haj subsidy was used to fleece the Muslim Pilgrims. I am sure the Haj tickets are much cheaper.
dear Hassan, dont bother yourself with airfare calcuations. This Naqwi is a stupid parallysed minister of BJP-RSS group. Though he has tongue but he cant speak his own, he has to be feeded by his superiors and spit the same. who the hell he to decide the number of piligrims to perform Hajj, is KSA is fathers property? he is thinking we Indian Muslims are stupid? i doubt he is a muslim (he is not). for your info, dont calculate airfare and expenses which is bound to occur during this holy deed. Islam has clearly emphasized "Hajj shall be performed for healthy and wealthy slaves" lets Ask Allah to all of us blesssed to reach that holy place and paerform our Hajj in sha Allah. Government subsidy is my foot....
He think he and his party fool people in each and every occations. What ever the quota saudi government provides, that much people will go to Hajj every year depend upon the Quota.
Record number of pilgrims ...without subsidy is a slap on you and Modi government.....
Mr mininster, We dont want Subsidy But please compare the air fare now and during HAj season. If you control on that then people will realise that you had did something positive. Airfare regular price from mumbai to jeddah is around Rs 25000/- But during Ramadan and Hajj seoson its crosses more then Rs 75000/- Differrence is more then what government was giving Susidy. So dont fool the nation. Keep control on Air fare. Jai hind
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