CM Yogi’s drive to identify CAA beneficiaries runs into problems

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, Jan 15: The mother of 23-year-old paramedic student, who was raped and brutally assaulted by six men in December 2012, on Tuesday said she knew that the curative petitions of the convicts will be rejected and is confident that they will be hanged on January 22.

Her remarks came after the Supreme Court on Tuesday refused to stay the execution of two of the four death row convicts in the 2012 Nirbhaya gang rape and murder case while dismissing their curative petitions against their conviction and capital punishment.

"The curative please had to be rejected. This was the third time they had gone to the Supreme Court. Whatever pleas they file, we are ready to face them and we will fight it out. We feel that they will be hanged on January 22. We want that to happen," Nirbhaya's mother told PTI over phone.

The four convicts -- Vinay Sharma (26), Mukesh Kumar (32), Akshay Kumar Singh (31) and Pawan Gupta (25) -- are to be hanged on January 22 at 7 am in Tihar jail as a Delhi court issued their death warrants on January 7.

Vinay and Mukesh had filed curative petitions on January 9.

Shortly after the apex court refused to stay the execution of two of them, Mukesh moved a mercy petition before President Ram Nath Kovind.

Mukesh also approached the Delhi High Court for quashing the death warrant. The high court is expected to take up his petition on Wednesday.