Fake degree: Delhi court rejects plea to summon Smriti Irani

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, Jun 4: Press Council of India (PCI) member BR Gupta has resigned from his post, saying he was unable to work individually or collectively for the media, which is in a "deep crisis".

"I have tendered my resignation as a Press Council of India member," Gupta told PTI.

He said the PCI had the responsibility to encourage media and media professionals constantly.

"But everyone now realises that the media scenario is in a deep crisis. The motto for which the Council was created was not being fulfilled and I felt I was not doing anything remarkable for the freedom of media," Gupta said.

He claimed that the PCI was not a wholly representative body for the media.

"Then how can we come out of the crisis being faced by the media and mediapersons? It is a big challenge for us. I have quit as I have not been able to work individually or collectively being a PCI member," Gupta added.

Referring to salary cuts and job losses, he said media and mediapersons were struggling for social, political and economic justice.

When contacted, PCI chairman Justice C K Prasad said Gupta's resignation has not been accepted yet.

"I have received it (the resignation). I have not gone through it. It has not been accepted," Prasad told PTI.

Gupta was appointed as a PCI member for a three-year term on May 30, 2018.

He said liberty is one of the basic features of the preamble to the Constitution that continues to inspire people and the media.

"It is difficult (for me) to fulfil the unbiased role and responsibility to help citizens and the media for making democracy stronger," Gupta said.