Security, welfare of people are govt's priority: Amit Shah

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.

Ayodhya, Jul 18: The Shri Ram Janmabhoomi Teertha Kshetra Trust has invited Prime Minister Narendra Modi to lay the foundation stone of a grand Ram Temple in Ayodhya either on August 3 or 5, both auspicious dates, said a spokesperson.

PM Modi had announced the formation of the Shri Ram Janmabhoomi Teertha Kshetra Trust on February 5.

Mahant Kamal Nayan Das, the spokesperson of Ram Mandir Trust president Nritya Gopal Das said, "We have suggested two auspicious dates -- August 3 and 5 -- for the prime minister's visit based on calculations of movements of stars and planets."

After a protracted legal tussle, the Supreme Court had on November 9 last year paved the way for the construction of a Ram Temple by a Trust at the disputed site in Ayodhya and directed the Centre to allot an alternative 5-acre plot to the Sunni Waqf Board for building a new mosque at a "prominent" place in the holy town in Uttar Pradesh.

New Delhi, May 25: India witnessed the highest ever spike of 6,977 positive cases in the last 24 hours, taking the total number of COVID-19 to 1,38,845, according to the Union Ministry of Health and Family Welfare.

India is now among the top 10 countries in the world regarding the total number of COVID-19 cases.

With 154 deaths reported in the last 24 hours, the total number of deaths due to COVID-19 now stands at 4,021 in the country.

Out of the total number of cases, 77,103 are active cases and 57,721 have been cured/discharged/migrated.

Maharashtra continues to remain the worst affected state with 50,231 COVID-19 cases, followed by Tamil Nadu (16,277), Gujarat (14,056) and Delhi (13,418).

The fourth phase of the nationwide lockdown imposed as a precautionary measure to contain the spread of COVID-19 is scheduled to end on May 31.