Govt to amend Pocso Act, extend protection to minor male victims

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.

Kochi, Feb 29: When Major Abdul Rahim, a soldier in the Afghan army, died in a bomb blast in Kabul on February 19, a tear was shed for him in far away Ernakulam district of Kerala.

The major had received a transplant of hands from Eloor native T G Joseph back in 2015, and the latter’s family had grown attached to the Afghan soldier.

Maj. Abdul Rahim, a bomb disposal expert, had lost his hands in an explosion in 2012. For three years thereafter, he struggled with his handicap. Then, when 54-year-old Joseph passed away in a road accident, it was decided to give his hands to the Afghan major.

The transplant procedure was successfully performed by a team of doctors led by Dr. Subrahmania Iyer at the Amrita Institute of Medical Sciences in Kochi.

After the transplant and an intensive spell of physiotherapy, Abdul Rahim could regain a considerable part of his hands’ functions. He rejoined the army and returned to defuse bombs in his war-torn country.

In gratitude, Major Abdul Rahim would visit Kochi every year to meet Joseph’s family. 

“We were shocked to hear of the demise of Major Abdul Rahim. Though Joseph left us, a part of him lived on. Abdul Rahim was a living memorial for us. Whenever he came to the Amrita institute for a consultation, we used to visit him,” Joseph’s wife was quoted as saying by Mathrubhoomi daily.

Major Abdul Rahim struck up a good friendship with his predecessor, in a way of speaking: the first person to have had a successful hand transplant at the Amrita Institute of Medical Sciences. T R Manu became a close friend of the Afghan solider and kept regularly in touch.