Two-thirds of AIDS treatment drugs supplied globally by India

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, Jun 28: With 19,906 new cases, highest single-day spike so far, India's COVID-19 count touched 5,28,859 including 2,03,051 active cases, 3,09,713 cured/discharged/migrated, according to the Ministry of Health & Family Welfare.

410 deaths were reported in the last 24 hours and the cumulative toll reached 16,095 deaths.

Coronavirus cases in Maharashtra have climbed to 1,59,133 while Delhi's tally stands at 80,188.

2,31,095 samples were tested yesterday and the total number of samples tested up to 27 June is 82,27,802, according to the Indian Council of Medical Research (ICMR).

New Delhi, Jan 19: Reacting to a tweet by ace lawyer Indira Jaising urging her to forgive the four men on death row for brutally raping that finally took her life, Nirbhaya's mother said on Saturday: "Even if God asks me, I won't forgive them."

Speaking to news agency, over the phone, the mother who had been fighting for seven long years to send her daughter's killers to the gallows, said, "...even if god comes and asks me to forgive them, I will not. People like these (Jaising) are a blot on the society."

Commenting on Jaising's tweet, she said: "Who is she to tell or suggest to me to forgive them. What relation does she have with me. I have nothing to do with such people. She can be a relative of those (the convicts) that she is having a soft corner for."

"She is an insult to women. She is running a business in the name of human rights. She is a veteran, she should give a message to the society. But she instead will go against her own kind," she added.

Earlier in the day, Jaising had requested Nirbhaya's mother to follow the example of Congress president Sonia Gandhi, who had moved for the clemency of a woman, Nalini Murugan convicted for the assassination of her husband and former Prime Minister Rajiv Gandhi.

"While I fully identify with the pain of Nirbhaya's mother I urge her to follow the example of Sonia Gandhi who forgave Nalini and said she didn't want the death penalty for her. We are with you but against death penalty," Jaising tweeted on Friday.

A Delhi Court on Friday issued fresh death warrants against the four convicts -- Akshay, Pawan, Mukesh and Vinay in the Nirbhaya gang rape and murder case.

Additional Sessions Judge (ASJ) Satish Kumar Arora fixed 1 February as the date of execution of the four death row convicts. They will be hanged at 6am.

The move came after the prosecution moved an application seeking issuance of fresh death warrants following the rejection of the mercy plea of one of the convicts Mukesh by President Ram Nath Kovind.

The 23-year-old victim was brutally gang-raped and tortured on December 16, 2012, which later led to her death.

All the six accused were arrested and charged with sexual assault and murder. One of the accused was a minor and appeared before a juvenile justice court, while another accused committed suicide in Tihar Jail.

Four of the convicts were sentenced to death by a trial court in September 2013, and the verdict was confirmed by the Delhi High Court in March 2014 and upheld by the Supreme Court in May 2017, which also dismissed their review petitions.