Supreme Court reinstates Alok Verma as CBI Director

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, Apr 17: With 1,076 new cases of COVID-19 in the last 24 hours and 32 deaths, India's total count of coronavirus cases has surged to 13,835, said the Union Ministry of Health and Family Welfare on Friday.

The total cases are inclusive of 1,766 cured and discharged patients, one migrated and 452 deaths. At present, there are 11,616 active COVID-19 cases in the country.

Before the lockdown, the doubling rate of COVID-19 cases was about three days, but according to the data of the past 7 days, the doubling rate of cases now stands at 6.2 days, said Lav Aggarwal, Joint Secretary, Health and Family Welfare.

"Before the lockdown, doubling rate of COVID-19 cases was about three days but according to the data of past 7 days, the doubling rate of cases now stands at 6.2 days," Aggarwal said during the daily briefing on COVID-19.

Aggarwal said that as many as 5 lakh rapid antibody testing kits are being distributed to States and Districts where a high case burden has been observed.

"A total of 1,919 dedicated COVID-19 hospitals with 1.73 lakh isolation beds, 21,800 ICU beds readied in India," he added. 

New Delhi, May 31: Congress leader Kapil Sibal on Sunday questioned the Prime Minister on how much money has been given to labourers from the PM-CARES Fund.

"I would like to ask Prime Minister Modi, 'Can you tell us how much money did you give to labourers from your PM-CARES Fund?' I request him to answer this question. Many people died during this period, some died while walking, some died in the train, some died of hunger," Sibal said while addressing a virtual press conference.

The senior Congress leader further asked how much ex gratia did the Prime Minister give to the labourers who died in the corona crisis while negotiating the lockdown.

"I refer you to Section 12 of the Disaster Management Act. It says that ex gratia assistance on account of the loss of life and also assistance for the restoration of livelihood should be provided by the government. Did the government give ex gratia assistance to people who died in the crisis? The act also mentions special provisions for widows and orphans. The government should clarify how much assistance they gave to such people," he said.

Sibal said that the government should keep aside its agenda for the last six years and concentrate on making pro-poor policies.

"In the coming days, our economy is going to go into the negative territory as also confirmed by RBI. There are 45 crore labourers in our country. What will be their state? We have to look at our future. That is why we want to request the government that the agenda that they have run over the last six years should be kept aside and that government should care about the poor and draft policies for them," the Congress leader said.