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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 2: With 2,293 new cases in the last 24 hours, the highest number of cases in a single day, India's COVID-19 tally reached 37,336 on Saturday, including 1,218 deaths, according to the Ministry of Health and Family Welfare.
As many as 71 deaths were reported in the last 24 hours.

Out of the total number, 9,951 people have been cured/discharged/migrated.

In the state of Maharashtra, the number of coronavirus positive cases has crossed the 10,000-mark with at least 485 deaths.

The positive cases in Maharashtra has reached 11,506, including 1,879 discharged cases.

After Maharashtra, Gujarat has the most number of COVID-19 cases (4,721). The state has reported 236 deaths, while 735 people have been discharged.

The Centre on Friday extended the ongoing nationwide lockdown for two more weeks with effect from May 4 till May 17 while allowing different sets of relaxations in red, orange and green zones.

New Delhi, Mar 5: The primary classes of all schools in the national capital will remain closed till March 31 to prevent a possibility of spread of coronavirus, Deputy Chief Minister Manish Sisodia announced on Thursday.

According to Directorate of Education (DoE) officials, while elaborate guidelines have been issued about preventive measures for coronavirus, students of nursery and primary classes are too young to understand the risk, making them more prone to infectious diseases.

Sisodia, who also holds the education portfolio, tweeted, "As a precautionary measure to prevent the possibility of spread of COVID-19 amongst our children, Delhi Government has directed the immediate closure of all primary schools (Govt/ aided/ private/MCD/NDMC) till 31/3/20(sic)."

A senior DoE official said, "Elaborate guidelines have already been issued. However, students of nursery and primary classes are too young to understand the risks associated with COVID-19. Thus they are more prone to infectious diseases and mingle around with classmates more often."

"It will be good if they are trained in the do's and dont's under the care and supervision of their parents at home. However, students of classes other than primary will continue to come to schools or examination centres for writing their examination as per schedule. The teaching, as well as non-teaching staff, will also attend regular school," the official said.

As of now, the number of confirmed COVID-19 cases in the country stands at 30, including 16 Italian tourists. The figure includes the first three cases reported from Kerala last month who have already been discharged following recovery.

Alerted by the coronavirus case reported in Delhi-NCR, schools in the region have sent out advisories to parents suggesting that they do not send their wards to attend classes even in case of mild cough or cold, and saying that they may declare holidays if the need arises. A few schools have announced already holidays and others have advanced their spring break.