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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 16: India's pharmaceutical industry will be able to produce Covid-19 vaccines not just for the country but also for the entire world, according to Microsoft co-founder and philanthropist Bill Gates.

A lot of "very important things have been done" in India and its pharma industry is doing work "to help make the coronavirus vaccine building on other great capacities that they have used for other diseases", said the Co-Chair and Trustee of Bill and Melinda Gates Foundation.

Speaking in a documentary -- Covid-19: India's War Against The Virus -- to be premiered on Discovery Plus this (Thursday) evening, Gates said India also faces a huge challenge due to the health crisis because of its gigantic size and urban centres with a lot of population density.

Commenting on the strength of India's pharma industry, he said, "India has a lot of capacity there -- with the drug and vaccine companies that are huge suppliers to the entire world. You know, more vaccines are made in India than anywhere-- starting with Serum Institute, that's the largest."

He further said, "But (there are) also Bio E, Bharat (Biotech), many others. They are doing work to help make the coronavirus vaccine, building on other great capacities that they have used for other diseases."

Stating that India joined Coalition for Epidemic Preparedness Innovations (CEPI), which is a group working on a global basis to build vaccines platforms, Gates said, "I am excited that the pharmaceutical industry there will be able to produce not just for India but also for the entire world. (This is) What we need to reduce the deaths and make sure we are immune, which is how we end the epidemic."

Gates said Bill and Melinda Gates Foundation is also a "partner with the government, particularly with the department of biotechnology, the Indian Council of Medical Research (ICMR) and the office of the principal scientific advisor provide advice and help about getting these tools going".

Commenting on the deadly virus breaching India's borders in the documentary which was shot extensively during the period of lockdown, he said, "India is still at the beginning of this, but there's a lot of very important things have been done.

“It's a huge challenge with India because you've got a gigantic country. You've got your urban centers with a lot of density-- and so that-- drives the spread. You have people moving around."

He, however, added: "Yet people are stepping up... Looking at how we reduce the spread while trying not to reduce food availability, equipment that people need."

Highlighting Gates foundation's role, he said it has "worked for the Indian government on health issues like introducing new vaccines over the last decade; and so when Covid-19 came along, we stepped in and said you know where are the gaps, we have been funding work on detection and isolation.

“We have been particularly active in UP and Bihar where we have done health delivery in the past."

The foundation is also working with the department of personnel and training to take their online training platforms and "are now using that guidance to help their frontline health workers", Gates said. 

New Delhi, Jul 10: With the highest single-day spike of 26,506 COVID-19 cases and 475 deaths reported in the last 24 hours, the total number of COVID-19 cases in India reached 7,93,802 on Friday, according to the Union Ministry of Health and Family Welfare.

Out of the total number of cases, 2,76,685 are active, 4,95,513 have been cured/discharged/migrated and 21,604 have died so far due to the infection.

With as many as 2,30,599 COVID-19 cases, Maharashtra continues to remain the worst-affected state, followed by Tamil Nadu (1,26,581) and Delhi (1,07,051).

Meanwhile, 2,83,659 samples were tested for coronavirus on Thursday, taking the total number of samples tested up to July 9 to 1,10,24,491, according to the Indian Council of Medical Research (ICMR).