Kerala: LDF's Mani Kappan wins Pala bye-polls; first defeat for Cong in 54 yrs

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.

Lucknow, Jul 10: Samajwadi Party supremo Akhilesh Yadav on Friday raised questions on gangster Vikas Dubey's encounter killing after an accident, saying the car did not topple but it was an effort to save the government from toppling if facts came to light.

Dubey was killed in an encounter after a police vehicle carrying him from Ujjain to Kanpur met with an accident and he tried to escape from the spot, police said.

"Darasal ye car nahi palti, raj khulne se sarkar palatne se bach gayi hai," (Actually, the car did not topple. It is an effort to save the government which would have toppled if facts came to light)," Yadav said in a tweet in Hindi.

Senior Superintendent of Police (Kanpur) Dinesh Kumar P said that the accident took place in the morning when it was raining heavily and the police vehicle overturned near Kanpur.

Eight policemen, including DSP Devendra Mishra, were ambushed in Bikru village in Chaubeypur area of Kanpur when they were going to arrest Dubey and fell to bullets fired from rooftops shortly after midnight on July 3.

Kochi, Jan 22: The Left front government in Kerala on Monday decided to inform the Centre it would not cooperate with the updation of the NPR, saying there were fears among the public about the process and it has the "Constitutional responsibility" to alleviate them and ensure law and order.

A special cabinet meeting, chaired by Chief Minister Pinarayi Vijayan here, decided to inform the Registrar General and Census Commissioner under the Union Home Ministry that it was unable to cooperate with anything with regard to the updation of the NPR.

"The decision was taken as it was the Constitutional responsibility of the government to alleviate the fears of general public and ensure law and order situation in the state," a Chief Minister's Office release said.

However, the state would fully cooperate with the census procedures, it said.

The LDF government, which has been on a warpath against the Centre over the Citizenship Amendment Act, has last month stayed all activities related to updation of NPR, considering 'apprehensions' of public that it would lead to NRC in the wake of the controversial CAA.

"As the NPR is a process that leads to the National Register of Citizens (NRC), there is a sense of fear among the people that its implementation could lead to widespread insecurity", the CMO release said on Monday.

The experience of the state which had already compiled the NRC was an example for this, it added, in apparent reference to Assam.

Kerala had already stopped all procedures regarding the NPR updation, the release said adding there was also a report of the state police that the if the government went ahead with the procedures, it would adversely impact the law and order situation.

The district collectors have also informed the government that the Census procedures would be affected if the updation of the NPR was done along with it, the CMO release said.

The CPI(M)-led LDF government had recently convened a meeting of political parties and socio-religious organisations here on December 29 in the wake of the concerns among people in various stratas of the society, it said.

A special assembly session was convened and a resolution was passed requesting the Centre not to implement the CAA and the government had also approached the apex court against the law, it added.