Lok Sabha election ends, India awaits verdict

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.

Feb 22: Prime Minister Narendra Modi is unlikely to accompany US President Donald Trump and his family members during their visit to the Taj Mahal in Agra on Monday, official sources said.

The US President will arrive in Ahmedabad at around noon on February 24 for a less that 36-hour visit to India. He will be accompanied by a high-level delegation including First Lady Melania Trump, the President's daughter Ivanka Trump, son-in-law Jared Kushner and a galaxy of top US officials.

After attending an event at Ahmedabad, the Trumps will travel to Agra on Monday afternoon to visit the Taj Mahal before arriving at the national capital for the main leg of the visit.

When asked about reports that Modi may accompany Trump to Agra, official sources said there was no such plan.

They said the visit to the Taj Mahal in Agra by the US President and his family members will afford them the opportunity to view the historical monument suitably. Therefore, no official engagements or presence of senior dignitaries from the Indian side is envisaged there, the sources said.

New Delhi, Jan 15: The Delhi government Wednesday told the high court that execution of the death row convicts in the Nirbhaya gangrape and murder case will not take place on January 22 as a mercy plea has been filed by one of them.

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. A Delhi court had issued their death warrants on January 7.

Justices Manmohan and Sangita Dhingra Sehgal were told by the Delhi government and the Centre that the petition filed by convict Mukesh, challenging his death warrant, was premature.

The Delhi government and the prison authorities informed the court that under the rules, it will have to wait for the mercy plea to be decided before executing the death warrant.

They also said that none of the four convicts can be executed on January 22 unless the present mercy plea is decided.

The Supreme Court had on Tuesday dismissed the curative pleas of Mukesh and Vinay.

The mercy plea hearing began Wednesday morning and will continue in the afternoon.