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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.

New Delhi, Jun 11: The death toll due to COVID-19 rose to 8,102 and the number of cases climbed to 2,86,579 in the country after it registered the highest single-day spike of 357 fatalities and 9,996 cases till Thursday 8 AM, according to the Union Health Ministry data.

The number of recoveries remained more than the active novel coronavirus cases for the second consecutive day.

The number of active cases stands at 1,37,448 while 1,41,028 people have recovered and one patient has migrated to another country, as per the data.   

"Thus, around 49.21 per cent patients have recovered so far," an official said.

The total number of confirmed cases include foreigners.

Of the 357 new deaths reported till Thursday morning, 149 were in Maharashtra, 79 in Delhi, 34 in Gujarat, 20 in Uttar Pradesh, 19 in Tamil Nadu, 17 in West Bengal, eight in Telangana, seven each in Madhya Pradesh and Haryana, four in Rajasthan, three each in Jammu and Kashmir and Karnataka, two each in Kerala and Uttarakhand, one each in Andhra Pradesh, Bihar and Himachal Pradesh.

Out of the total 8,102 fatalities, Maharashtra tops the tally with 3,438 deaths followed by Gujarat with 1,347 deaths, Delhi with 984, Madhya Pradesh with 427, West Bengal with 432, Tamil Nadu with 326, Uttar Pradesh with 321, Rajasthan with 259 and Telangana with 156 deaths.

The death toll reached 78 in Andhra Pradesh, 69 in Karnataka and 55 in Punjab. Jammu and Kashmir has reported 51 fatalities due to the coronavirus disease, while 52 deaths have been reported from Haryana, 33 from Bihar, 18 from Kerala, 15 from Uttarakhand, nine from Odisha and eight from Jharkhand.

Chhattisgarh and Himachal Pradesh have registered six COVID-19 fatalities each, Chandigarh has five while Assam has recorded four deaths so far. Meghalaya, Tripura and Ladakh have reported one COVID-19 fatality each, according to the ministry's data.

More than 70 per cent of the deaths are due to comorbidities, the ministry's website stated.