Ram Janambhoomi Trust invites PM Modi to lay foundation for temple on Aug 3 or 5

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 10: The Supreme Court on Monday upheld the constitutional validity of the SC/ST Amendment Act, 2018, and said a court can grant anticipatory bail only in cases where a prima facie case is not made out.

A bench headed by Justice Arun Mishra said a preliminary inquiry is not essential before lodging an FIR under the act and the approval of senior police officials is not needed.

Justice Ravindra Bhat, the other member of the bench, said in a concurring verdict that every citizen needs to treat fellow citizens equally and foster the concept of fraternity.

Justice Bhat said a court can quash the FIR if a prima facie case is not made out under the SC/ST Act and the liberal use of anticipatory bail will defeat the intention of Parliament.

The top court's verdict came on a batch of PILs challenging the validity of the SC/ST Amendment Act of 2018, which was brought to nullify the effect of the apex court's 2018 ruling, which had diluted the provisions of the stringent Act.

Thiruvananthapuram, Apr 13: Three more people in Kerala tested positive for novel coronavirus disease on Monday, said Chief Minister Pinarayi Vijayan.

"With 3 new COVID-19 cases, the total number of cases in the state has reached 378," said Vijayan at a press conference.

Giving a break-up of the three confirmed COVID-19 cases, he said, "Of the 3 cases, 2 are from Kannur and 1 is from Palakkad."

He further said, "Till date, 15,683 samples tested, out of which 14,829 tested negative."

However, the total number of positive cases is decreasing, the Chief Minister added.

According to a recent update by the Ministery of Health and Family Welfare, the total number of cases in the country has reached 9352.