56 percent turnout in final phase of Bihar polls

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, Jul 11: A notice which claims that a COVID-19 Monitoring Committee has been formed is fake, and no such committee has been set up by the Union Home Ministry, as per Spokesperson, Ministry of Home Affairs (MHA).

The "Fake" MHA order stated, "Pursuant to the official orders received dated: Monday, May 18, 2020, of the Honourable Minister of Home Affairs, passed in the approval of Special Status Advisory Committee for COVID-19, a COVID-19 Monitoring Committee has been constituted in the MHA vide order dated: Friday, June 12, 2020."

MHA Spokesperson also cautioned people to beware of fake news and rumours.

India's COVID-19 case count crossed the eight lakh-mark on Saturday with yet another highest single-day spike of 27,114 new cases in the last 24 hours.

New Delhi, May 14: India may witness the death of additional 1.2-6 lakh children over the next one year from preventable causes as a consequence to the disruption in regular health services due to the COVID-19 pandemic, UNICEF has warned.

The warning comes from a new study that brackets India with nine other nations from Asia and Africa that could potentially have the largest number of additional child deaths as a consequence to the pandemic.

These potential child deaths will be in addition to the 2.5 million children who already die before their fifth birthday every six months in the 118 countries included in the study.

The estimate is based on an analysis by researchers from the Johns Hopkins Bloomberg School of Public Health published in the Lancet.  

This means the global mortality rate of children dying before their fifth birthday, one of the key progress indicators in all of the global development, could potentially increase for the first time since 1960 when the data was first collected.

There were 1.04 million under-5 deaths in India in 2017, of which nearly 50% (0.57 million) were neonatal deaths. The highest number of under-5 deaths was in Uttar Pradesh (312,800 which included 165,800 neonatal deaths) and Bihar (141,500 which included 75,300 neonatal deaths).

The researchers looked at three scenarios, factoring in parameters like reduction in workforce, supplies and access to healthcare for services like family planning, antenatal care, childbirth care, postnatal care, vaccination and preventive care for early childhood. The effects are modelled for a period of three months, six months and 12 months.  

In scenario-1 marked by 10-18% reduction of coverage of all the services, the number of additional children deaths could be in the range of 30,000 plus over three months, more than 60,000 over six months and above 120,000 over the next 12 months.

Coronavirus India update: State-wise total number of confirmed cases, deaths on May 13

The numbers sharply rose to nearly 55,000; 109,000 and 219,000 respectively for scenario-2, which was associated with an 18-28% drop in all the regular services.

But in the worst-case scenario in which 40-50% of the services are not available, the number of additional deaths ballooned to 1.5 lakhs in the three months in the short-range to nearly six lakhs over a year.

The ten countries that could potentially have the largest number of additional child deaths are Bangladesh, Brazil, Congo, Ethiopia, India, Indonesia, Nigeria, Pakistan, Uganda and Tanzania.

In countries with already weak health systems, COVID-19 is causing disruptions in medical supply chains and straining financial and human resources.

Visits to health care centres are declining due to lockdowns, curfews and transport disruptions, and due to the fear of infection among the communities. Such disruptions could result in potentially devastating increases in maternal and child deaths, the UN agency warned.