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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.

Jammu, Jan 15: Fresh landslides kept the Jammu-Srinagar National Highway shut for the third consecutive day on Wednesday, leaving over 5000 vehicles stranded.

"There were four fresh landslides in Digdol and Panthiyal belts on the highway in Ramban district. The traffic on the highway remained closed for the third day today", a police officer told PTI.

On Monday, heavy rains triggered shooting of stones in Moumpassi, Digdole and Panthiyal areas, forcing a suspension of the traffic, the official said.

Snowfall in Kashmir side of the highway, including Jawahar Tunnel, since Sunday has resulted in blockade of the highway.

"No fresh traffic was allowed from Nagrota in Jammu for Kashmir", he said.

As a result of the blockade of the highway, over 5000 vehicles remained stranded at various places en route from Lakhanpur in Kathua district to Banihal belt of Ramban district and also on the Kashmir side.

India has jumped past 4.5 lakh coronavirus cases and 14,476 people have succumbed to the viral infection so far. In this backdrop, speaking to IANS in an exclusive interview, AIIMS Director Randeep Guleria said India is also vulnerable to second wave of coronavirus and people should continue to follow social distancing, wearing mask and other precautions, after cases begin to decline.

He added that in order to contain the outbreak of Covid-19, a limited lockdown in hotspots, where volume of cases is very high, may be considered along with a micro-plan to prevent leakage of cases from these areas to other non-containment areas. Excerpts of the interview are below:

Q: Reports say China and South Korea are witnessing a second wave of coronavirus infection, what is this second wave, is India also vulnerable to this?

A: When cases come down significantly, people tend to drop their guard against the viral infection, and this leads to the second wave (which means a sudden increase in the number of cases). After cases begin to decline, people should continue to follow the precautions -- continue to maintain social distancing and wear masks regularly. See what happened in Singapore, it was struck by a second wave of coronavirus. Look, what happened in the 1918 pandemic, people dropped their guard and the second wave of viral infection struck back. If people do not follow social distancing then the spike in cases is apparent. We need to take these precautions at least for one year. India is also vulnerable to this second wave.

Q: If Covid-19 cases continue to rise rapidly, do you think we need another lockdown in areas where volume of cases are very high?

A: A large volume of cases is concentrated in specific areas like hotspots, and in order to maintain things in order, we may need a limited lockdown in these areas. This should be followed by a micro-plan which entails extensive testing of people and also extensive contact tracing of people who have got in touch with positive people. Need to ensure there is no leakage of cases from these areas. People from these areas should not mix with others in non-containment areas. This will aid in containing the outbreak of the virus. People who have developed symptoms should get themselves tested, especially in the containment areas.

Q: With more than 4.5 lakh cases and close to 14,500 deaths, do you think India has reached its peak and a decline in cases is prominent?

A: The cases will continue to increase for some time. The doubling time of cases has also increased. But, the cases will also begin to flatten. Though, it is difficult to give an exact time period in this viral infection, it seems, the growth in cases will flatten in the end of July or beginning of August. A decline will come to this viral infection, but it does not mean that people should drop their guard. As a measure, we need to decrease community participation and citizens should continue to follow social distancing. People should get themselves tested. All these efforts will help in preventing people from contracting this virus. These precautions will also prevent us from the second wave, and we must continue to take precautions. The virus has not gone away, it is still lurking.

Q: India has crossed the 4.5 lakh coronavirus cases so far, although our recovery rate is good, but still 10,000 to 15,000 cases are reported daily. Why do cases continue to spiral, what is the reason?

A: We have to remember a few things -- the bulk of cases are in 10 cities, nearly 70 per cent, and if we take into account cases per million population, the number is not very high, as compared with countries including countries in Europe. Many European countries put together still do not add up to the Indian population. Do not compare India to countries like Italy, Spain etc. We need to focus on hotspots, which contribute to between 70 -80 per cent of cases, and we have to identify cases in these areas at an early stage. The population density is very high in these cities. People in lower socio-economic status are highly vulnerable to the viral infection, as many live together in small spaces and there is a lot of mixing of people happening there. Look at the market places, people are not following social distancing and not wearing masks. In fact, many are in close vicinity of each other.