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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, Apr 7: The death toll due to novel coronavirus rose to 114 and the number of cases in the country climbed to 4,421 on Tuesday, according to the Union Health Ministry.

While the number of active COVID-19 cases stood at 3,981, as many as 325 people were cured and discharged, and one had migrated, it stated. The total number of cases include 66 foreign nationals.

According to the ministry's data updated at 9 am, three new deaths were reported from Rajasthan, while Tripura recorded its first coronavirus case.

Maharashtra has reported the most coronavirus deaths at 45, followed by Gujarat at 12, Madhya Pradesh nine, Telangana and Delhi seven each, Punjab six and Tamil Nadu five fatalities.

Karnataka registered four deaths, while West Bengal, Uttar Pradesh, Andhra Pradesh and Rajasthan have recorded three fatalities each. Two deaths each have been reported from Jammu and Kashmir and Kerala. Bihar, Himachal Pradesh and Haryana have reported one fatality each, according to the health ministry data.

However, a PTI tally based on figures reported by states directly on Monday night showed at least 138 deaths across the country, while the confirmed cases reached 4,683. Of them, 359 have been cured and discharged.

There has been a lag in the Union Health Ministry figures, compared to the numbers announced by different states, which officials attribute to procedural delays in assigning the cases to individual states.

The highest number of confirmed cases are from Maharashtra at 748, followed by Tamil Nadu at 621 and Delhi with 523 cases. Kerala reported 327 COVID-19 cases, Telangana 321, Uttar Pradesh 305 and Rajasthan 288 cases. Andhra Pradesh reported 226 coronavirus cases.

Novel coronavirus cases have risen to 165 in Madhya Pradesh, 151 in Karnataka and 144 in Gujarat. Jammu and Kashmir has 109 cases, West Bengal has 91, Haryana 90 and Punjab 76 cases of the infection.

Thirty-two people were infected with the virus in Bihar while Uttarakhand has 31 patients and Assam 26. Odisha reported 21 coronavirus cases, Chandigarh 18, Ladakh 14 and Himachal Pradesh 13 cases.

Ten cases each have been reported from the Andaman and Nicobar Islands and Chhattisgarh. Goa has reported seven COVID-19 infections, followed by Puducherry with five cases. Jharkhand has reported four cases and Manipur two. Tripura, Mizoram and Arunachal Pradesh have reported one case of the infection each.

"State-wise distribution is subject to further verification and reconciliation," the ministry said on its website.