Sonia Gandhi fine, 'relieved' that Food Bill was passed, Modi wishes her good health

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, Mar 28: The total number of coronavirus positive cases in the country has risen to 918 that include foreign nationals, the Ministry of Health and Family Welfare said on Saturday.

The ministry said: "The total positive cases of coronavirus are 918. The active COVID-19 cases are 819. Cured and discharged are 79. While 19 deaths have occurred so far. One person with COVID-19 migrated. As many as 15,24,266 passengers were screened at airports."

Prime Minister Narendra Modi on Tuesday announced a 21-day lockdown in the entire country to deal with the spread of coronavirus, saying that "social distancing" is the only option to deal with the disease, which spreads rapidly.

Ahmedabad, Feb 24: US President Donald Trump and his wife Melania on Monday tried their hands at spinning the 'charkha' (spinning wheel) at the Sabarmati Ashram here.

Accompanied by PM Narendra Modi, the US president and his wife went around the Ashram, before resuming the roadshow from the airport to the Motera stadium. "To my great friend Prime Minister Naredra Modi, thank you for this wonderful visit," Trump wrote in the Ashram visitors' book.

The US President was briefed about Gandhiji and the importance of charkha as a symbol of self reliance. Trump reached Ahmedabad at 11.37 am for the first leg of his India visit.

US President Donald Trump arrived in Ahmedabad on Monday for the first leg of his India trip. The Air Force One plane carrying Trump and his wife Melania landed at the Sardar Vallabhbhai Patel international airport here at 11.37 am, officials said. It was scheduled to land at 11.40 am.

Trump, who is also accompanied by daughter Ivanka, son-in-law Jared Kushner and top brass of his administration, will get a taste of India's cultural melange during his high- optics Gujarat itinerary, after the bonhomie between the two leaders at the 'Howdy, Modi!' event in Houston last year.