Munda resigns after JMM ends support

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.

Thiruvananthapuram, Apr 11: The effective handling of Covid-19 pandemic by the Kerala Government has received a big endorsement in the International media with the latest being a report in Washington Post which suggests that the State’s success could prove instructive to the entire country.

The Washington Post quoted Kerala Health Minister K K Shailaja Teacher as saying “We hoped for the best but planned for the worst. Now, the curve has flattened, but we cannot predict what will happen next week.”

"The Minister said six states had reached out to Kerala for advice. She, however, noted that it might not be easy to replicate Kerala’s lessons elsewhere," according to the Minister's office quoting the report here on Saturday.

New Delhi, Jan 1: Prevention of Money Laundering Act (PMLA) court in Mumbai has allowed banks that lent money to embattled liquor tycoon Vijay Mallya to utilize seized assets, news agency reported today quoting sources from the Enforcement Directorate (ED). The court also said all parties affected by the order can appeal at the Bombay High Court till January 18.

Last month, a consortium of Indian banks petitioned a London court for ex-billionaire Vijay Mallya to be declared bankrupt over ₹9,000 crore in unpaid debts. It comes as Mallya, who founded the now defunct Kingfisher Airlines Ltd, faces extradition to his home country of India.

Mallya had fled India in March 2016 and has been living in the United Kingdom since then. The 64-year-old former Kingfisher Airlines is fighting extradition to India in relation of fraud and money laundering allegations arising out of the debt acquired from the banks.

Mallya remains on bail pending the UK High Court appeal hearing in the extradition proceedings brought by India in relation to fraud and money laundering charges amounting to ₹9,000 crores. He had been arrested on an extradition warrant back in April 2017 and has been fighting his extradition in the UK courts since then.

He was granted permission to appeal against his extradition order, which is scheduled in the Royal Courts of Justice in London for February.