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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, May 26: As India ranked 10th in the global infection list, overtaking Iran, which was an early hotspot of coronavirus, India's top medical body has said the human trials of COVID-19 vaccine may begin at least in six months.

Dr. Rajni Kant, Director Regional Medical Research Centre and Head at the Indian Council of Medical Research (ICMR) said, "The virus strain isolated at the National Institute of Virology (NIV) laboratory in Pune will be used to develop the vaccine, and this strain has been successfully transferred to the Bharat Biotech International Ltd. (BBIL). It is expected that the human trials of the vaccine will begin in at least six months."

Queried on the focus areas as India inches closer to 1.4 lakh COVID-19 cases, Kant said we should not get anxious about the rapid increase in numbers, especially in the past week, which saw 5,000 Covid-19 cases daily, instead focus on protecting the most vulnerable group.

"We should not fear from increasing Covid-19 cases. The elderly and people with comorbidities need protection. This is the highly vulnerable group, and we need to deploy resources and develop strategies to keep the mortality rate as low as possible in this group," said Kant.

Initially, it was assumed that the country would require thousands of ventilators, but last week, the health ministry said only 0.45 per cent of COVID-19 cases need ventilator support.

Kant insisted the focus should be on five per cent to 10 per cent serious patients. "We are testing more than one lakh daily and our case fatality rate is already one of the lowest in the world. In absence of vaccine, people should follow social distancing guidelines," he added

On the significance of the recovery rate, Kant said the increasing recovery rate of the COVID-19 patients, which is at 41 per cent, is a bright spot in India's fight against deadly viral infection.

Queried on large scale COVID-19 cases in Mumbai, Delhi and Ahmedabad, Kant said the population density in these regions is very high, which proves to be the just right environment for the viral infection.

He insisted on developing robust cluster management strategies in the hard-hit coronavirus spots, and the movement of people should be curtailed in these areas.

"Currently, a lot of people are moving around easily and avoiding social distancing norms. The first phase of the lockdown was very effective, but now things have changed," added Kant.

Mar 19: Amidst spiralling cases of COVID-19 in the country, Union Minister of State for Health and Family Welfare Ashwini Kumar Choubey on Thursday advocated "absorbing sunlight" as a possible precaution against coronavirus that has claimed over 8,000 lives globally.

Speaking to reporters outside parliament, Choubey said 10-15 minutes in the sun would build immunity as sunlight provides Vitamin D.

"From 11 am to 2 pm the sun is shining brightly. We should spend at least 10-15 minutes to absorb sunlight so that we get vitamin D which improves the immunity of our body and also kills such viruses. All should be aware of (this fact)," he said when asked about the spread of coronavirus.

COVID-19 cases in India climbed to 169 on Thursday after 18 fresh cases were reported from various parts of the country, according to the Union health ministry.

The cases include 25 foreign nationals -- 17 from Italy, 3 from the Philippines, two from the UK, one each belonging to Canada, Indonesia and Singapore.

The figure also includes three deaths reported from Delhi, Karnataka and Maharashtra so far.

According to the World Health Organisation, the novel coronavirus has killed over 8,000 people globally and infected more than two lakh.