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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 6: The government on Tuesday said that the Food Corporation of India, the nodal agency for procurement and distribution of foodgrains, has sufficient stocks in its godowns, even after meeting the requirement of additional wheat and rice provided free of cost during the lockdown period.

Food Minister Ram Vilas Paswan has given detailed information about the various steps taken by the government and the total stocks of food grains and pulses available with the government and sent to the states till now, an official statement said.

"FCI currently has 276.61 lakh tonnes rice and 353.49 lakh tonnes wheat. Hence a total of 630.10 lakh tonnes food grain stock is available," it said.

As against this, about 60 lakh tonnes of food grains is required for a month under the NFSA (National Food Security Act) and other welfare schemes.

Paswan said FCI stocks are comfortable even after fulfilling extra commitments during the lockdown.

Under the 'Pradhan Mantri Garib Kalyan Ann Yojana', the Centre is providing 5 kg of free food grains per month to 80 crore ration card holders. This free of cost wheat and rice will be provided for three months. Besides, 1 kg of pulses will also be supplied per family.

This is over and above the normal quota of 5 kg of food grains provided per month per person to about 80 crore people under the food law.

The minister informed that since the lockdown, about 69.52 lakh tonnes of food grains have been transported through 2,483 rail rakes.

Apart from rail route, transportation was also done through roads and waterways. A total of 137.62 lakh tonnes has been transported.

During the lockdown, NGOs and social institutions running relief camps can purchase wheat and rice directly from FCI Depots at Open Market Sales Scheme (OMSS) rate.

The state governments can also purchase food grains directly from FCI. Under the OMSS, the rate of rice is fixed at Rs 22 per kg and wheat at Rs 21 per kg.

Under the 'Pradhan Mantri Garib Kalyan Ann Yojana', for the next 3 months a total of 104.4 lakh tonnes rice and 15.6 lakh tonnes of wheat is required of which 59.50 lakh tonnes rice and 8.14 lakh tonnes wheat have been lifted by various states and UTs.

The Government of India is bearing 100 per cent financial burden of approximately Rs 46,000 crore under the scheme, the statement said.

For pulses, the total requirement for the next three months is 5.82 lakh tonnes.

So far, 2,20,727 tonnes of pulses have been dispatched, while 1,47,165 tonnes of pulses have reached the states/UTs and 47,490 tonnes have been delivered, it said.