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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, Mar 11: A doctor in Kerala on Tuesday alleged that she was sacked by the management of the private clinic she was working with for informing authorities about a non-resident Indian (NRI) patient who reportedly declined to undergo the mandatory check for coronavirus.

Dr Shinu Syamalan said the patient had come to the clinic recently with suspected symptoms of the virus.

"When he was asked whether he had visited any foreign countries, he said he was coming from Qatar. But he had not reported to the Health department about his foreign trip," she said.

When he was directed to inform about his foreign travel to the state Health Department, which has been monitoring people coming from abroad for the virus, he refused and said he was going back to Qatar, she told reporters.

Concerned over the health of the person who had high fever, Ms Syamalan informed health and police authorities.

"Officials who let the patient go abroad do not have any problem, but I have become jobless," she posted on social media.

She alleged she was sacked by the management of the clinic for reporting the matter to police and informing the public about the incident through social media and through television.

"The argument of the management is that no one would turn up for treatment in the clinic if they come to know that it was visited by patients with suspected symptoms of Coronavirus," she said.

There was no immediate reaction from the management of the private health clinic.

Official sources said the District Medical Officer (DMO) at Thrissur has complained to the collector against Shinu Syamalan accusing her of defaming health officials.