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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, Jul 21: The Centre has written to all states and union territories warning against the use of N-95 masks with valved respirator by people, saying these don't prevent the virus from spreading out and are "detrimental" to the measures adopted for its containment.

The Director-General of Health Services in the Ministry of Health, in a letter to the Principal Secretaries of health and medical education of states, said it has been observed that there is "inappropriate use" of N-95 masks, particularly those with valved respirator, by the public other than designated health workers.

The DGHS referred to the advisory on the use of homemade protective cover for face and mouth available on the website of the Ministry of Health.

"It is to bring to your knowledge that the use of valved respirator N-95 masks is detrimental to the measures adopted for preventing the spread of coronavirus as it does not prevent the virus from escaping out of the mask. In view of the above, I request you to instruct all concerned to follow the use of face/mouth cover and prevent inappropriate use of N-95 masks," DGHS Rajiv Garg said in the letter.

The government had in April issued an advisory on the use of homemade protective cover for face and mouth, asking people to wear it, particularly when they step out of their residences.

The advisory stressed such face covers must be washed and cleaned each day, as instructed and states that any used cotton cloth can be used to make this face cover. 

The colour of the fabric does not matter but one must ensure that the fabric is washed well in boiling water for five minutes and dried well before making the face cover. Adding salt to this water is recommended, it said.

It also listed the procedures of making such homemade masks, asking to ensure it fits the face well and there are no gaps on the sides.

It urges people to wash hands thoroughly before wearing the face cover,  switching to another fresh one as the face cover becomes damp or humid, and never reusing it after single use without cleaning it. 

"Never share the face cover with anyone. Every member in a family should have separate face cover," the advisory stated.

New Delhi, Jun 13: India's COVID-19 tally on Saturday witnessed its highest-ever spike of 11,458 cases, according to the Union Ministry of Health and Family Welfare (MoHFW).

A total of 386 deaths have been reported due to the infection during the last 24 hours.

The total number of coronavirus cases in the country now stands at 3,08,993 including 1,45,779 active cases 1,54,330 cured/discharged/migrated and 8,884 deaths.

COVID-19 cases in Maharashtra continue to soar with the number reaching 101141. Tamil Nadu's coronavirus count stands at 40,698 while cases in Delhi reached 36,824.