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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.

Thiruvananthapuram, Mar 23: Amid a spurt in coronavirus cases, Kerala chief minister Pinarayi Vijayan has asked the Centre to give the states authority to give clearances for manufacturing masks, gloves and sanitisers.

In a letter addressed to prime minister Narendra Modi, Vijayan said during the crisis, masks and sanitisers are needed in large numbers.

"As an interim, states must be given authority to give clearances of manufacturing of items related to medical devices, sanitisers, chemicals, etc. which are needed for fighting Covid-19," Vijayan said in the letter.

He also sought permission for the state home department to use drones for the relevant applications related to Covid-19.

"In China and elsewhere in the world, drones have been used extensively in minimising human contact, disinfection, etc. Unfortunately, with the current laws pertaining to the use of drones, none of these is possible in India," the chief minister said.

He also sought permission to access and use facilities available with all central institutions and research labs operating in the state.

The chief minister shared the letter on his Twitter handle.

With 15 new positive cases of Covid-19, the total number of infected persons in Kerala had gone up to 67, including the three who were discharged after recovery last month.

Coronavirus lockdown in India has been extended till June 30 with more relaxations.

While the lockdown has been extended in containment zones, relaxations outside containment zones include reopening of religious places for public  from June 8. 

Hotels, restaurants and shopping malls also to open from June 8. Decision on opening educational institutions to be taken in July.