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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 24: The trajectory of COVID-19 cases could have plateaued and might even fall for some weeks after the lockdown is lifted but India is likely to see a second wave in late July or August with a surge in the number of cases during the monsoon, say scientists.

The timing of the peak will depend on how India is able to control physical distancing and on the level of infection spreads after restrictions are relaxed, they said.

It looks apparent that the trajectory of daily new cases has reached a plateau and eventually it will take a downward fall, maybe for some weeks or even months, Samit Bhattacharya, associate professor at the Department of Mathematics, Shiv Nadar University, said.

Still, we may get a surge of new cases of the same coronavirus and this will be considered a second wave, Bhattacharya explained.

The second epidemic may come back in late July or August in the monsoon, although the peak timing will depend on how we control social distancing during that time, he said.

Rajesh Sundaresan, professor at Bengaluru's Indian Institute of Science (IISc), agreed.

“Once we return to normal activity levels, there is a chance that infection may begin to rise again. China is seeing this to some extent post easing of some restrictions on travel,” Sundaresan, corresponding author of a working paper by researchers at IISc and the Tata Institute of Fundamental Research (TIFR) in Mumbai, said.

On March 25, when the number of coronavirus cases was 618 with 13 deaths, the government announced a nationwide lockdown that was later extended to May 3.

On Friday, the death toll due to COVID-19 rose to 718 and the number of cases to 23,077, according to the Union Health Ministry.

In good news, officials said this week that the doubling rate of cases has slowed down in the period, going from 3.4 days before lockdown to 7.5 days, with 18 states doing better than the national average. The recovery rate has also almost doubled in the last 10 days.

"Looking at the new cases in the past few days, it seems the growth of new daily infection is much slower than earlier. This apparently indicates that we might have reached at the plateau of the growth curve, Bhattacharya said.

He noted that recent studies in China and Europe observed that the infection might relapse in those people who have already recovered from earlier phases.

So, there is no evidence that the earlier infection may help acquire immunity against the second infection. And in that way, the entire population may be vulnerable to the second wave to some extent, said the scientist.

In their study unveiled this week, IISc and TIFR researchers analysed the impact of strategies such as case isolation, home quarantine, social distancing and various post-lockdown restrictions on COVID-19 that might remain in force for some time.

The study modelled on Bengaluru and Mumbai suggests the infection is likely to have a second wave and the public health threat will remain, unless steps are taken to aggressively trace, localise, isolate the cases, and prevent influx of new infections.

The new levels and the peaking times for healthcare demand depend on the levels of infection spreads in each city at the time of relaxation of restrictions, they said.

The lockdown is currently upon us. It has given us valuable time. Let us test, trace, quarantine, isolate, practice better hygiene, search for a vaccine, etc. We should do these anyway, and these are being done. When and how to lift the lockdown is going to be a difficult decision to make, said Sundaresan.

It's clear that it's going to be phased. What our team is focusing on is to come up with tools to help the decision makers assess the public health impact of various choices, he said.

According to the experts, infectious diseases spread via contact between infectious and susceptible people. In the absence of any control measures, an outbreak will grow as long as the average number of people infected by each infectious person is more than one.

Once enough people are immune there will be fewer people susceptible to the infection and the outbreak will die.

However, when an outbreak is brought under control by social distancing and other interventions, it is possible only a small proportion of the population will have been infected and gained immunity, they said.

This means enough susceptible people may remain to fuel a second wave if controls are relaxed and infection is reintroduced.

Until the vaccine comes on the market, we have to remain alert Once sporadic cases occur here and there in the country, we immediately need to implement quarantine or social distancing locally for the people in that region, and also need to perform tests to identify positive cases irrespective of showing symptoms, Bhattacharya explained.

Note that these monsoon months are also flu season in many places of India. So, we should not ignore the early signs of the flu symptoms. Irrespective of symptoms, we need to increase tests in the hotspots to identify people and contain the surge, he said.

Sundaresan added that the timeline for a second wave will depend on a lot of circumstances which may change as the time passes.

Significant testing may have been underway, there may be behavioural changes with people becoming more careful about their hygiene, wearing masks may become more common, etc. All these responses may help restrict the second wave, he said.

A study published in The Lancet journal earlier this month modelled the potential adverse consequences of premature relaxation of interventions, and found it might lead to a second wave of infections.

The finding is critical to governments globally, because it warns against premature relaxation of strict interventions, the researchers said.

While interventions to control the spread of SARS-CoV-2 are in place, countries will need to work toward returning to normalcy; thus, knowledge of the effect of each intervention is urgently required, they said in the study.

According to a recent analysis by the Harvard Chan School of Public Health, the best strategy to ease the critical care burden and loss of life from COVID-19 might be on-again, off-again social distancing.

In the absence of such interventions, surveillance and intermittent distancing may need to be maintained into 2022, which would present a substantial social and economic burden, the researchers wrote.p

New Delhi, May 31: A low pressure area formed over Arabian sea and Lakshadweep is likely to intensify further into a cyclonic storm and reach coastal states of Maharashtra and Gujarat next week, the Indian Meteorological Department (IMD) said on Sunday.

Sunitha Devi, in charge of cyclones at IMD, said, "A low pressure area has formed over southeast and adjoining east central Arabian sea and Lakshadweep area. It is very likely to concentrate into a depression during the next 24 hours and intensify further into a cyclonic storm during subsequent 24 hours."

She added, "It is likely to move nearly northwards and reach near north Maharashtra and Gujarat coasts by 3rd June."

A low pressure area and a depression are the first two levels on the IMD's eight-category scale used to classify cyclones based on their intensity.

The weather bureau said that the sea condition will be very rough and advised fishermen not to venture into the sea till June 4.

It has forecast heavy to very heavy rainfall over south coastal Maharashtra for June 2-4, on north coast on June 2-3 and in Gujarat, Daman and Diu and Dadar and Nagar Haveli on June 3-5.

IMD said that under the influence of likely formation of a low pressure system over Arabian Sea, conditions will become favourable from June 1 for onset of monsoon over Kerala.

The arrival date for monsoon in Kerala is around June 1 every year and in Maharashtra around June 10.

On Saturday, a private forecasting agency claimed that monsoon has already hit Kerala, but the assertions were quickly rebutted by the Ministry of Earth Sciences.

"The news about monsoon onset over Kerala in Social Media is not correct. Monsoon has not arrived over Kerala. The greatest enemy of knowledge is not ignorance, it is the illusion of knowledge a"Stephen Hawking," saidAMadhavan Rajeevan, Secretary, Ministry of Earth Sciences.

Kuldeep Srivastava, the head of IMD's Regional Weather Forecasting Centre said that the formation of a low pressure system in Arabian sea and its movement towards Gujarat coast will bring moisture to Delhi-NCR and North West India from June 3.

Two storms are forming over the Arabian Sea, one lies off the African coast and is likely to move over Oman and Yemen, while the other is placed close to India.

The development comes almost ten days after 'Amphan' pummeled four districts of Bengal in the fiercest cyclone in the region in a century, that left 86 people dead and rendered ten million people homeless.