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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 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.

Jun 13: The Congress on Saturday accused the BJP-led government of burdening the common man with high taxes on petrol and diesel and earning Rs 2.5 lakh crore since March 5.

Congress leader Kapil Sibal said while international crude oil prices have fallen and are at the lowest level in 15 years, yet petrol and diesel prices are skyrocketing and common people continue to suffer under the Modi dispensation.

He said instead of passing the benefit of lower crude prices to consumers, petrol and diesel prices were hiked for the seventh straight day on June 13.

"The government has earned as much as Rs 44,000 crore in the last six days due to hike in petrol, diesel prices. Since March 5, the government has earned as much as Rs 2.5 lakh crore by way of increasing petrol, diesel prices.

"If the government had even the slightest feelings for the common man, instead of benefitting the companies and the government, the prime minister would have helped the common man with reduced fuel prices," Sibal said at an online press conference.

According to a report by Care Ratings, he said the hike effectively meant that the Central government is collecting around 270 per cent taxes on the base price of petrol and 256 per cent in case of diesel.

The former union minister said petrol was selling at Rs 71.41 in Delhi on May 1, 2014, when international crude oil prices were USD 106.85, while on June 12, 2020, the price of petrol was Rs 75.16 when the crude oil was at USD 38.

He said central excise and VAT cumulatively account for 69 per cent of tax on fuel in India which is higher than anywhere else in the world. He said the tax of fuel in the US was 19 per cent, Japan 47 per cent, the UK 62 per cent, France 63 per cent and Germany 65 per cent.