Jethmalani quits as Kejriwal's counsel, seeks Rs 2 crore fee

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 9: The Electronic Voting Machines (EVMs) used in Delhi Assembly polls are kept under tight security, in the 'Strong Room' located at Atal Adarsh Bengali Balika Vidyalaya in Gol Market.

Voting for Delhi Assembly elections took place on Saturday with voters turnout well short of the 2015 election mark.

Counting of the votes will be on February 11.

Earlier, Deputy Election Commissioner Sudip Jain had said the Delhi elections took place peacefully and smoothly.

New Delhi, May 4: Rebutting the Congress' criticism, the BJP said on Monday that the railways has subsidised 85 per cent of ticket fare for special trains being run for migrant workers and the state governments have to pay the remaining 15 per cent.

The ruling party also accused the Congress of promoting indiscriminate movement of people which, it said, would lead to "faster spread" of coronavirus infection "just like we saw in Italy", and asked if this is what Sonia Gandhi wants.

The counter-charge from BJP leaders, including its spokesperson Sambit Patra and information technology department in-charge Amit Malviya, came after Congress president Sonia Gandhi hit out at the central government for making migrants pay for their train fare and asked her party's state units to pick the tab.

Congress leader Rahul Gandhi also took a swipe at the railways, saying, on one hand, it is seeking ticket fare from people stranded in various states while on the other it is donating Rs 151 crore to the PM-CARES Fund.

Responding to him, Patra said, "Rahul Gandhi ji, I have attached guidelines of MHA which clearly state that 'No tickets to be sold at any station'. Railways has subsidised 85% & state govt to pay 15%. The state govt can pay for the tickets (Madhya Pradesh's BJP govt is paying). Ask Cong state govts to follow suit," Patra tweeted.

The BJP leader further clarified that for each 'Shramik Express', special trains being run for migrants to take them back to their native places during the lockdown, about 1,200 tickets to the destination are handed by the railways to the state government concerned.

State governments are supposed to clear the ticket price and hand over the tickets to workers, he said.

He said the BJP government in Madhya Pradesh is doing so and asked Rahul Gandhi to tell the Congress-ruled states to follow suit.

Hitting out at Sonia Gandhi, Malviya tweeted, "Congress is obviously upset at how well India has handled Covid. They would have ideally wanted a lot more people to suffer and die. Promoting indiscriminate movement of people would lead to faster spread of infection, just like we saw in Italy. Is this what Sonia Gandhi wants?"

BJP MP Subramanian Swamy claimed that migrant workers returning home will not have to pay money as the rail travel will be free from now onwards.

"Talked to Piyush Goyal office. Govt will pay 85% and State Govt 15%. Migrant labour will go free. Ministry will clarify with an official statement," he tweeted.

BJP Congress Coronavirus COVID-19 Coronavirus lockdown Italy Sonia Gandhi Rahul Gandhi Sambit Patra Amit Malviya Subramanian Swamy Piyush Goyal