Delhi court orders invesitgation in Owaisi hate speech case

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.

Mar 16: A fourth batch of 53 Indians returned to India from Iran on Monday, taking the total number of people evacuated from the coronavirus-hit country to 389.

This comes a day after over 230 Indians were brought back from Iran to New Delhi and quarantined at the Indian Army Wellness Centre in Jaisalmer, the third batch to be evacuated from that country.

"Fourth batch of 53 Indians - 52 students and a teacher - has arrived from Tehran and Shiraz, Iran. With this, a total of 389 Indians have returned to India from Iran. Thank the efforts of the team @India_in_Iran and Iranian authorities," Jaishankar tweeted.

The Indians came in a Mahan Air flight that landed at the Delhi airport at around 3 am, officials said, adding that they were later taken to Jaisalmer in an Air India flight for being quarantined.

The first batch of 58 Indian pilgrims were brought back from Iran last Tuesday and the second group of 44 Indian pilgrim arrived from there on Friday.

Iran is one of the worst-affected countries by the coronavirus outbreak and the government has been working to bring back Indians stranded there. Over 700 people have died from the disease in Iran and nearly 14,000 cases have been detected.

Jaishankar had told Rajya Sabha last week that the government was focusing on evacuating Indians stranded in Iran and Italy as these countries are facing an "extreme situation".

New Delhi, May 11: Former prime minister Manmohan Singh is stable and under observation at the AIIMS here after suffering reaction to a new medication and developing fever, hospital sources said on Monday.

The 87-year-old Congress leader was admitted to the hospital on Sunday evening after he complained of uneasiness. He has now been shifted out of the ICU.

The sources said that Singh had developed a reaction to a new medication and further investigation is being carried on him to rule out other causes of fever.

"Dr Manmohan Singh was admitted for observation and investigation after he developed a febrile reaction to a new medication," the sources said.

"He is being investigated to rule out other causes of fever and is being provided care as needed. He is stable and under care of a team of doctors at the Cardiothoracic Centre of AIIMS," they said.

"All his parameters are fine. He is under observation at the AIIMS," a source close to him has said.

Singh, a senior leader of the opposition Congress, is currently a Member of Rajya Sabha from Rajasthan. He was the prime minister between 2004 and 2014.

In 2009, Singh underwent a successful coronary bypass surgery at the AIIMS. A number of leaders expressed have expressed concern over his health and wished him a speedy recovery.