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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.

May 14: The UN’s children agency has warned that an additional 6,000 children could die daily from preventable causes over the next six months as the COVID-19 pandemic weakens the health systems and disrupts routine services, the first time that the number of children dying before their fifth birthday could increase worldwide in decades.

As the coronavirus outbreak enters its fifth month, the UN Children’s Fund (UNICEF) requested USD 1.6 billion to support its humanitarian response for children impacted by the pandemic.

The health crisis is “quickly becoming a child rights crisis. And without urgent action, a further 6,000 under-fives could die each day,” it said.

With a dramatic increase in the costs of supplies, shipment and care, the agency appeal is up from a USD 651.6 million request made in late March – reflecting the devastating socioeconomic consequences of the disease and families’ rising needs.

"Schools are closed, parents are out of work and families are under strain," UNICEF Executive Director Henrietta Fore said on Tuesday.

 “As we reimagine what a post-COVID world would look like, these funds will help us respond to the crisis, recover from its aftermath, and protect children from its knock-on effects.”

The estimate of the 6,000 additional deaths from preventable causes over the next six months is based on an analysis by researchers from the Johns Hopkins Bloomberg School of Public Health, published on Wednesday in the Lancet Global Health Journal.

UNICEF said it was based on the worst of three scenarios analysing 118 low and middle-income countries, estimating that an additional 1.2 million deaths could occur in just the next six months, due to reductions in routine health coverage, and an increase in so-called child wasting.

Around 56,700 more maternal deaths could also occur in just six months, in addition to the 144,000 likely deaths across the same group of countries. The worst case scenario, of children dying before their fifth birthdays, would represent an increase "for the first time in decades,” Fore said.

"We must not let mothers and children become collateral damage in the fight against the virus. And we must not let decades of progress on reducing preventable child and maternal deaths, be lost,” she said.

Access to essential services, like routine immunisation, has already been compromised for hundreds of millions of children and threatens a significant increase in child mortality.

According to a UNICEF analysis, some 77 per cent of children under the age of 18 worldwide are living in one of 132 countries with COVID-19 movement restrictions.

The UN agency also spotlighted that the mental health and psychosocial impact of restricted movement, school closures and subsequent isolation are likely to intensify already high levels of stress, especially for vulnerable youth.

At the same time, they maintained that children living under restricted movement and socio-economic decline are in greater jeopardy of violence and neglect. Girls and women are at increased risk of sexual and gender-based violence.

The UNICEF pointed out that in many cases, refugee, migrant and internally displaced children are experiencing reduced access to protection and services while being increasingly exposed to xenophobia and discrimination.

“We have seen what the pandemic is doing to countries with developed health systems and we are concerned about what it would do to countries with weaker systems and fewer available resources,” Fore said.

In countries suffering from humanitarian crises, UNICEF is working to prevent transmission and mitigate the collateral impacts on children, women and vulnerable populations – with a special focus on access to health, nutrition, water and sanitation, education and protection.

To date, the UN agency said it has received USD 215 million to support its pandemic response, and additional funding will help build upon already-achieved results.

Within its response, UNICEF has reached more than 1.67 billion people with COVID-19 prevention messaging around hand washing and cough and sneeze hygiene; over 12 million with critical water, sanitation and hygiene supplies; and nearly 80 million children with distance or home-based learning.

The UN agency has also shipped to 52 countries, more than 6.6 million gloves, 1.3 million surgical masks, 428,000 N95 respirators and 34,500 COVID-19 diagnostic tests, among other items.

New Delhi, Jan 7: The government has asked public sector undertakings to dissuade their employees from participating in the 'Bharat Bandh' called on Wednesday and advised them to prepare a contingency plan to ensure smooth functioning of the enterprises.

Ten central trade unions have said around 25 crore people will participate in the nationwide strike to protest against the government's "anti-people" policies.

Trade unions INTUC, AITUC, HMS, CITU, AIUTUC, TUCC, SEWA, AICCTU, LPF, UTUC along with various sectoral independent federations and associations had adopted a declaration in September last to go on the nationwide strike on January 8.

"Any employee going on strike in any form, including protest, would face the consequences which, besides deduction of wages, may also include appropriate disciplinary action," said an office memorandum issued by the government.

"Suitable contingency plan may also be worked out to carry out the various functions of the ministry/department," it added.

It also issued instructions not to sanction casual leave or other kind of leave to employees if applied for during the period of the proposed protest or strike and ensure that the willing employees are allowed hindrance-free entry into the office premises.

The instructions issued by the Department of Personnel & Training prohibit the government servants from participating in any form of strike, including mass casual leave, go-slow and sit-down, or any action that abet any form of strike.

Besides, pay and allowances are not admissible to an employee for his absence from duty without any authority.

The central trade unions are protesting against labour reforms, FDI, disinvestment, corporatisation and privatisation policies and to press for a 12-point common demands of the working class relating to minimum wage and social security, among others.