L K Advani stakes claim to fight LS polls from Gandhinagar seat

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, Feb 23: Hailing the role of first Prime Minister Jawaharlal Nehru in shaping India a modern nation state, former Prime Minister Manmohan Singh on Saturday hit out at the Narendra Modi-led Central government, saying "nationalism" and the slogan of 'Bharat Mata Ki Jai' are being misused to construct a militant and purely emotional idea of India.

Speaking at the launch of a book on Jawaharlal Nehru's works and speeches, Singh said: "I am extremely happy that this book makes an effort to revisit Pandit Nehru. He had led this country in its volatile, formative days when we adopted democratic way of life, accommodating divergent social and political views."

The former Prime Minister said that Nehru, who was very proud of Indian heritage, "assimilated it", and harmonised them into the needs of a "new modern" India.

"A great visionary, Nehruji laid the foundation for shaping India as a modern nation state," he said.

Highlighting the works of the first Prime Minister, Singh said: "If India is recognized in the comity of nations as a vibrant democracy and, if it is considered as one of the important world powers, it was Nehru, who should be recognised as its main architect."

He said Nehru was not only a statesman of high international standing, but a great historian and literary figure too.

"With an inimitable style, and a multi-linguist, Nehru laid the foundation of the universities, academies and cultural institutions of Modern India. But for Nehru's leadership, Independent India would not have become what it is today," he said.

Taking an apparent dig at the BJP government, he said: "But unfortunately, a section of people who either do not have the patience to read history or would like to be deliberately guided by their prejudices, try their best to picture Nehru in a false light.

"But I am sure, history has a capacity to reject fake and false insinuations and put everything in proper perspective," he said.

He said the book "Who is Bharat Mata" is such an attempt to set the narrative in the right direction.

Singh said that selecting appropriate pieces from Nehruji's works, the book justifies its title "Who is Bharat Mata?"

"As this book contains a timely collection of writings by and on Pandit Jawaharlal Nehru- the leader, who shaped India and the Icon whose legacy is the subject of intense and often angry reaction today.

The book also comprises reminiscences and assessments of Nehru by some of his contemporaries and near contemporaries-among them, including Mahatma Gandhi, Bhagat Singh, Sardar Patel, Maulana Azad, Aruna Asaf Ali, Sheikh Abdullah, Ramdhari Singh Dinkar, Ali Sardar Jafri, Baldev Singh, Martin Luther King Jr, Richard Attenborough, Lee Kuan Yew and Atal Bihari Vajpayee.

"It is a book of particular relevance at a time when nationalism and the slogan of ‘Bharat Mata Ki Jai' are being misused to construct a militant and purely emotional idea of India that excludes millions of residents and citizens," Singh said attacking the BJP government.

The two time Prime Minister further said that in the pages of the carefully complied anthology-which also carries illuminating introductions by the authors Nehru emerges as a "remarkable man of ideas and action", who had an instinctive understanding of India's civilisational spirit and as a visionary with clear commitment to the promotion of scientific temper, who despite the compulsions of politics, remained a true democrat.

"His legacy continues to be of immense significance-perhaps more today than at any other time in our history," he said.

He also warned that "Nehru makes a very significant and time relevant remark on the dangers of leaderships falling into a trap and getting removed far away from the common people whom they are supposed to serve".

"In an atmosphere, when emotions are deliberately get provoked and the gullible are misled by false propaganda, misusing communication technology, this book makes a refreshing break through," Singh added.

New Delhi, Jun 4: CSIR Director-General Shekhar Mande said on Thursday that the World Health Organisation's (WHO) decision to halt hydroxychloroquine (HCQ) drug trial was taken in haste and the global body should have actually analysed the data before making the decision.

"I firmly believe that WHO decision was taken in haste it was a kind of knee jerk reaction they should have actually analyse the data on their own before temporarily suspend the trials that is my personal opinion," Mande said.

India's nodal government agency ICMR (Indian Council of Medical Research) overseeing the country's response to the coronavirus pandemic last month wrote to the WHO citing differences in dosage standards between Indian and international trials that could explain the efficacy issues of HCQ in treating COVID-19 patients.

In addition, Dr Sheela Godbole, National Coordinator of the WHO-India Solidarity Trial and Head of the Division of Epidemiology, ICMR-National AIDS Research Institute also wrote a letter via an email to Dr Soumya Swaminathan, Chief Scientist at World Health Organisation.

In a letter, Dr Godbole stated: "There was no reason to suspend the trial for safety concern," attributing it to the current RECOVERY data which differs significantly from the non-randomised assessment by Mehra et al, a scientific paper.

Referring to the letter, the CSIR head said, "We don't know what actually happened behind the scenes but the hypothesis is that because of the paper published in Lancet. It is a very well known journal and if Lancet has done due vigilance in publishing the paper. 

Therefore, the WHO thought the paper's findings are right that's why WHO hold based on what is published on Lancet. The WHO shouldn't have accepted it immediately this should have taken their own due vigilance to find out that study is right or not."

DG CSIR said because there is a global outcry it must have put pressure on both Lancet as well as WHO and both of them now retracted from their original position. "WHO has started a trial again and Lancet has put an expression of concern on their website both of these are very welcome development for science," he said.

"So I am pretty sure that Lancet would have published the reports only after seeing somewhere the drug failed to work," Mande said.