Union Cabinet approves over Rs 8,500 crore for updating National Population Register

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, Mar 20: The government on Thursday said one Indian who tested positive for coronavirus has died in Iran while the other citizens infected with the disease are being provided treatment and taken care of by the Iranian government.

Noting that the virus tends to be more fatal for those whose immunity levels are low, a senior MEA official said the deceased, an elderly person, belonged to the vulnerable age group and had health-related complications.

The death was not because of lack of medical attention or care, he said.

"We have evacuated 590 people from Iran where the situation is very severe. The Indians infected with coronavirus in Iran have been segregated and taken care of very well by the government there. We believe they will recover and we will bring them back," the MEA official said, adding that 201 Indians were evacuated from Iran on Wednesday.

The official said closely knit families required some persuasion and counselling during the process of segregation to prevent the spread of the contagion.

The Indian ambassador and other officials explained the consequences of infected people not being separated from their families and were successful to a large extent in segregating the positive cases from the negative ones, he said.

"Some pilgrims and students are still there and our embassy and mission are in control (of the situation)," the official said.

Jan 27: The Andhra Pradesh Cabinet passed a resolution on Monday setting in motion the process for abolishing the state Legislative Council.

A similar resolution will now be adopted in the Legislative Assembly and sent to the Centre for necessary follow-up action.

With just nine members, the ruling YSR Congress is in minority in the 58-member Legislative Council. The opposition Telugu Desam Party (TDP) has an upper hand with 28 members and the ruling party could get a majority in the House only in 2021 when a number of opposition members will retire at the end of their six-year term.

The move by the Andhra Pradesh cabinet came after the Y S Jaganmohan Reddy government last week failed to pass in the Upper House of the state legislature two crucial Bills related to its plan of having three capitals for the state.

Andhra Pradesh Legislative Council Chairman M A Sharrif on January 22 referred to a select committee the two bills -- AP Decentralisation and Inclusive Development of All Regions Bill, 2020, and the AP Capital Region Development Authority (CRDA) Act (Repeal) Bill -- for deeper examination.

The chairman had said that he was using his discretionary powers under Rule 154 while referring the Bills to the select panel in line with the demand of the TDP.

Following this, the chief minister had told the Assembly, "We need to seriously think whether we need to have such a House which appears to be functioning with only political motives. It is not mandatory to have the Council, which is our own creation, and it is only for our convenience."

"So let us discuss the issue further on Monday and take a decision on whether or not to continue the Council," he had said.

In fact, the YSRC had on December 17 first threatened to abolish the Council when it became clear that the TDP was bent on blocking two Bills related to creation of a separate Commission for SCs and conversion of all government schools into English medium.

As the Legislature was adjourned sine dine on December 17, no further action was taken. But last week, the issue cropped up again as the TDP remained firm on its stand on opposing the three-capitals plan.

The YSRC managed to get two TDP members to its side, but the government failed to get the three capitals Bills passed in the Council.

"What will be the meaning of governance if the House of Elders does not allow good decisions to be taken in the interest of people and block enactment of laws? We need to seriously think about it… Whether we should have such a House or do away with it," the chief minister had said in the Assembly.