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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.

Washington, Jul 18: The Foreign Direct Investment (FDI) from the US to India has crossed the $40 billion mark so far this year, reflecting the growing confidence of American companies in the country, the head of an India-centric business advocacy group has said.

The American companies, during the Covid-19 pandemic, which has battered the world economy, have shown great confidence in India and its leadership, said Mukesh Aghi, president of the US-India Strategic and Partnership Forum (USISPF), which keeps a track of the major US FDIs in India.

“Year to date investment from the US, including the recent ones, is over $40 billion,” Aghi said.

In recent weeks alone, the announcement of the FDI into India has been over $20 billion, he said, referring to the announcements made by some of the top companies like Google, Facebook and Walmart.

“Investors’ confidence in India is high. India still remains a very promising market for global investors. If you look at the $20 billion… not just the US, but (investment) has also come from other geographies such as the Middle East and the Far East.

“So, India still remains a very, very bullish market for the investor community,” Aghi said in response to a question.

The USISPF has been working with New Delhi to bring in FDI into India… playing a key role in encouraging American companies planning to move their bases out of China, he said, adding that the move was going on in the last three years of the Trump administration, but gained momentum during the coronavirus pandemic.

“We feel that Prime Minister (Narendra Modi’s) intention is very high. The challenges lie on the execution side. Efforts are being made to encourage manufacturing… I've never seen it so better. The policy framework is moving in the right direction,” he said.

Early this week, Larry Kudlow, the White House Economic Advisor, told reporters that the US tech giants like Google and Facebook announcing big investments in India shows that people are losing trust in China and India is emerging as a big competitor.

At the same time, he rued that India continues to be a protectionist country.

“The question is how do you define protectionism... the administration here is saying America first and India is saying vocal for local…,” Aghi added.

New Delhi, Jul 3: India reported the highest ever single-day spike of 20,903 COVID-19 cases in 24 hours on Friday, said the Union Ministry of Health and Family Welfare.

With these new cases, India's coronavirus tally has risen to 6,25,544 cases of which 2,27,439 patients are active cases while 3,79,892 patients have been cured/discharged/migrated.

379 more deaths due to COVID-19 were reported in the country in the last 24 hours, taking the number of deaths due to the infection to 18,213.

As per the Health Ministry, Maharashtra -- the worst-affected state from the virus -- has a total of 1,86,626 cases including 8,178 fatalities while Tamil Nadu has 98,392 coronavirus cases in the state inclusive of 1,321 fatalities.

Delhi has reported 92,175 cases so far inclusive of 2,864 patients succumbing to the virus.

The Indian Council of Medical Research on Friday said that the total number of samples tested till July 2 is 92,97,749 of which 2,41,576 samples were tested on Thursday.