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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.

New Delhi, Jul 18: National carrier Air India on Friday said that it is in a ‘very challenging financial’ situation and is taking recourse to several initiatives, with a view to ensuring the continuance of its operations.

The airline, in a statement, noted that it has introduced the partially voluntary 'Leave Without Pay' (LWP) scheme on July 14.

"The scheme primarily enables employees to avail the benefits of proceeding on leave without pay on a voluntary basis. The LWP scheme has been introduced for grant of leave without pay and allowances for permanent employees for a period of six months or two years, which is extendable upto 5 years," the statement said.

"Air India had brought out similar scheme earlier... Several hundred employees have, in the past, availed of the LWP Scheme."

As per the statement, in the wake of the ongoing Covid-19 pandemic, there may be employees who are unable to attend their office duties in person on account of personal reasons.

"The LWP scheme enables employees to take a break from their office responsibility for a defined period of time with the approval of the management, while retaining their employment with the company," the statement said.

"They will continue to avail facilities such as passage, medical and housing at specified rates."

Accordingly, the LWP scheme provides the opportunity to employees to take up alternative employment with the approval of the management during the period of the said leave, the airline said.

"The LWP scheme is a win-win situation for both the management as well as employees as it provides flexibility to employees and simultaneously reduces the wage bill for the company," the statement said.

"It is important to note here that the Covid-19 outbreak has very seriously impacted the airline sector and currently, the airline operations of the company are a small fraction of the prior Covid level operations."

The airline said that employees are encouraged to apply for availing the benefit of the scheme, in the prescribed format, by August 15.

"The only addition in this scheme as compared to the earlier LWP scheme is that the management can pass an order requiring the employees to go on leave for a period of six months or two years (extendable upto 5 years) compulsorily taking into consideration 'Suitability, Efficiency, Competence, Quality of performance, Health, Non-availability of employee and Redundancy'," the statement said.

Furthermore, the airline said that this provision has been introduced for use, "very sparingly", with a view to ensuring that the overall efficiency of the organisation, improves and the management will ensure that this will be implemented with complete fairness and transparency as per prescribed procedure.

Consequent to the announcement of the scheme, Air India unions are discussing their strategy against the move which might involve legal recourse.

An Air India union leader on Friday told IANS: "This is going to affect the livelihood of many. Why not every employee of AI take LWP a few days every month. This way the burden can be shared."

"The motive of the top management is to save their money by snatching money from lower employees."

According to Air India PIM document, as on November 1, 2019, the airline, on a standalone basis (without subsidiaries), had around 14,000 employees, including fixed term contract staff.

The development comes as the Centre has re-initiated the airline's divestment plan with new norms.

Interestingly, this time, it has sweetened the deal by substantially reducing the debt on the airline's account books and offered a 100 per cent stake in the loss-making airline.

The last date for bid submission to acquire Air India has also been extended to August 31.