Terror attack on Amarnath yatra; 7 pilgrims killed

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, Feb 1: India has uplifted 271 million people out of poverty, Finance Minister Nirmala Sitharaman said on Saturday.

In her second Budget presentation, the finance minister said the Budget for 2020-21, is woven around aspirational India, economic development and caring society.

The government aims to achieve seamless delivery of services through digital governance, she added.

"We shall strive to bring ease of living for every citizen," Sitharaman said.

New Delhi, Apr 12: With 34 deaths and 909 new positive COVID-19 cases in the last 24 hours, the total number of coronavirus cases in India on Sunday climbed to 8356, including 716 cured and discharged and 273 deaths, said the Ministry of Health and Family Welfare.

At present, there are 7367 active COVID-19 cases in the country.

"A total number of COVID-19 positive cases rises to 8356 in India, including 716 cured/discharged, 273 deaths and 1 migrated," said the Health Department.

The highest number of positive cases of coronavirus was reported from Maharashtra at 1761, including 127 deaths, followed by Delhi (1069 and 19 deaths), Tamil Nadu (969 and 10 deaths) and Rajasthan (700 and 3 deaths).

There are 452 coronavirus positive cases in Uttar Pradesh, including 45 cured and discharged and 5 deaths.

The states which have crossed 200-mark for COVID-19 positive cases also include Madhya Pradesh (532), Telangana (504), Gujarat (432), Andhra Pradesh (381) and Kerala (364).

While 19 people were detected positive for coronavirus in Chandigarh, 207 cases were confirmed from Jammu and Kashmir and 15 from Ladakh.

In North-East, Assam has confirmed the highest number of corona positive cases at 29, followed by Manipur and Tripur at two each and Mizoram, Arunachal Pradesh at one each.