Sarabjit Singh slips into non-reversible coma

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.

Jaipur/New Delhi, Jul 12: The crisis in Rajasthan Congress has deepened with state Chief Minister Ashok Gehlot and his deputy Sachin Pilot at loggerheads.

While Gehlot is blaming BJP for trying to destabilise the state government by poaching MLAs, Pilot is camping in Delhi to speak to the party leadership regarding the political turmoil in the state.

According to sources, Pilot has sought an appointment with party's interim president Sonia Gandhi but time for the meeting has not yet been given by her. Although Pilot met another party leader to apprise him about the situation in the state and spelled out his grievance.

As of now, many MLAs, who are believed to be in the Pilot camp, are also in Delhi to meet the party leadership. According to sources, the deputy chief minister has the support of nearly 30 Congress MLAs along with many independent legislators.

It is important to note that the controversy broke out in Rajasthan after Special Operation Group (SOG) sent a notice to Sachin Pilot to record his statement in the case registered by SOG in the alleged poaching of Congress MLAs in the state. The clash between Gehlot and Pilot is also over the post of PCC Chief as Gehlot Camp wants that 'One Leader One Post' formula to be implemented in Rajasthan. Currently, Sachin Pilot is heading the PCC besides holding the Deputy CM post.

Sources close to Sachin Pilot have informed that the young leader is upset with the notice issued to him. He believes it is aimed to record his phone calls and keep him under surveillance. Many of Pilot's supporters feel indignation and told Pilot that they cannot work with Ashok Gehlot. Also, Pilot is unlikely to attend the meeting called by Gehlot today, according to sources.

While the top leadership of the party is keeping mum, sources say it is keeping a watch on the development. General Secretary KC Venugopal has taken up the matter of the rift with the party's top brass with them not happy about it.

Rajasthan AICC Incharge Avinash Pandey told media persons: "Everything is under control. Few MLAs had issues and after discussion, they have returned back to Jaipur and others are also in touch. BJP's attempt of destabilising the government will not be successful in Rajasthan and government is stable."

Gehlot also held a meeting with ministers last night in Jaipur.  According to Gehlot camp, the top leadership is apprised of the development of the poaching attempt in the state. Amid Political Crisis Rajasthan CM Ashok Gehlot called a meeting of Ministers and all Cong MLAs tonight at his residence.

The Rajasthan crisis has alerted the other senior leaders of the party who have opined that the Madhya Pradesh incident should not get repeated in Rajasthan.

Former Union Minister and Rajya Sabha MP Kapil Sibbal tweeted, "Worried for our party. Will we wake up only after the horses have bolted from our stables?"