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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, Apr 27: Prime Minister Narendra Modi on Monday held a video conference with chief ministers to discuss the situation arising due to the coronavirus pandemic in the country, which has been under a lockdown since March 25 to contain the spread of the virus, amid indications that the interaction would also focus on a graded exit from the ongoing lockdown.

This is Modi's fourth such interaction with state chief ministers since March 22 when he discussed coronavirus situation and steps taken both by the Centre and the states to contain the pandemic.

Two days later on March 24, Modi announced a 21-day nationwide lockdown. He extended the lockdown by 19 days on April 14, the last day of the initial three week shutdown, till May 3.

Sources in the government had on Sunday indicated that besides discussing the way forward in dealing with the pandemic, the prime ministers and chief ministers could also focus on a "graded" exit from the lockdown.

In a tweet on Monday, the Prime Minister's Office said Modi and the chief ministers will be discussing aspects relating to the COVID-19 situation.

In his monthly 'Mann ki Baat' radio address on Sunday, the prime minister said the country is in the middle of a 'yudh' (war) and asserted that people have to continue being careful and take precautions.

His note of caution came amidst gradual exemptions being granted by the Centre and states to revive economic activities.

"I urge you not to get overconfident. You should in your over-enthusiasm not think that if the coronavirus has not yet reached your city, village, street or office, it is not going to reach now. Never make such a mistake. The experience of the world tells us a lot in this regard," Modi said while referring to a popular Hindi idiom 'Sawdhani hati, durghatna ghati' (disaster strikes when you lower your concentration).

The Centre and the state governments have been giving gradual exemptions to boost economic activities as also to provide relief to people as some states want further relaxation in areas which have seen few or no coronavirus cases.

New Delhi, Jul 22: India is responding with utmost urgency to coronavirus from the very beginning and has been continuously strengthening preparedness and response measures, WHO Regional Director (South-East Asia) Poonam Khetrapal Singh said on Wednesday.

"India is responding with utmost urgency to COVID-19 from the start. It's been continuously strengthening preparedness and response measures, including ramping up testing capacities, readying more hospitals, arranging and stocking up medicines and essentials," Singh said at a virtual briefing.

"India took bold, decisive and early measures earlier in the outbreak. The country did not witness an exponential increase in cases like some other countries which reported their first few cases along with India. Like in any other country the transmission of COVID-19 is not homogenous in India. There are areas yet to see a confirmed case, some have sporadic cases, in some areas some small clusters while we are witnessing large clusters in some megacities from the densely populated areas," Singh said.
She said WHO was aware of varying capacities at sub-national levels.

"Not unusual in a country as big as India and its population size that measures taken may often not be uniformly sufficient across all areas. Scaling up capacities and response remains a constant need in India."

Replying on the question of what more needs to be done in controlling the spread of COVID-19, she said all countries including India must continue to implement core public health and social distancing measures.

"Local epidemiology to guide our response for finding hotspots and testing, detecting, isolating and providing care to the affected, promoting safe hygiene practices and respiratory etiquette, protecting health workers and increasing health system capacity is also key," she said.