More rain expected in Mumbai today, situation likely to worsen; people slam civic bodies

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, May 19: In a fresh blow to saffronite journalist Arnab Goswami, the Supreme Court of India today rejected his plea seeking transfer of the investigation of a case, filed against him for defaming Congress interim president Sonia Gandhi, to the CBI. The court also refused to quash the FIRs filed against him.

Goswami, editor-in-chief of Republic TV, has been booked in connection with a TV show on the gathering of migrants outside Bandra railway station on April 14. This apart, multiple FIRs have been filed against him for his show on Palghar lynching. In that show, he had posed certain questions on the incident to Congress President Sonia Gandhi, following which Congress workers lodged complaints against him in various states.

Extending Goswami’s interim protection from arrest by three weeks, the Supreme Court said, “Right of a journalist under 19 1 (a) higher…Free citizens can’t exist if news media can’t speak.”

During the earlier hearing, Senior Advocate Harish Salve, appearing for Goswami, had urged the court to transfer the probe to an agency like CBI. He said the “nature of the” second FIR against Goswami over a show on the migrant gathering outside Bandra station on April 14 “shows that it’s arm-twisting tactic”. 

“They are trying to stifle an unpleasant voice. This is a political party targeting a journalist. All complainants are members of one political party. They have a problem with the government. They want to teach this journalist a lesson,” he added.

Objecting to Salve’s plea to transfer the case to the CBI, Maharashtra government counsel, Senior Advocate Kapil Sibal, had said, “CBI investigation will go into your hands”. 

Sibal denied that Goswami was being harassed and said he was only asked relevant questions. He said Goswami should “stop this communal violence and communal mongering”.