Swami Aseemanand, associates acquitted in 2007 Makkah Masjid terror attack case

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, Jun 20: The government-imposed upper and lower limits on airfares may be extended beyond August 24 depending upon how the situation turns out, Aviation Secretary P S Kharola said on Saturday.

The government resumed domestic passenger flights from May 25 after nearly two months of suspension to combat the coronavirus outbreak, but placed lower and upper limits on airfares depending upon the flight duration.

It had said on May 21 that these limits would be in place for a period of three months.

"Depending on how the situation turns out, the fare band may have to adjusted beyond that (August 24) also. But right now, it is only for three months," Kharola said at a press conference here.

International passenger flights continue to remain suspended in the country.

However, the government started Vande Bharat Mission on May 6 to help stranded people reach their destinations through special flights.

Aviation Minister Hardeep Singh Puri said at the conference that during phase 3 and phase 4 of the mission, private domestic airlines have been approved to operate 750 international flights to repatriate people stranded amid the coronavirus pandemic.

Mumbai, Apr 2: NCP chief Sharad Pawar on Thursday

urged Muslims to observe Shab-e-Barat staying inside their homes, and also suggested that the birth anniversary celebrations of Dalit icon Dr B R Ambedkar be postponed in view of the coronavirus outbreak.

Pawar said Ram Navami, being observed on Thursday, is celebrated with fervour every year across the country.

"Unfortunately, there is this threat of coronavirus this year and we have to observe some restrictions...but I am sure people must be remembering Lord Ram staying inside their homes," he said in his address via Facebook.

Shab-e-Barat, also known as the night of forgiveness,will be observed on April 8.

Members of the Muslim community visit graveyards to remember their relatives who are no more, Pawar said, and called for taking precautions to avoid gathering of people given the coronavirus crisis.

Pawar said congregation such as the one held last month in Delhi's Nizamuddin area by Tablighi Jamaat could have been avoided, and urged people to ensure there is no repeat of such meetings on Shab-e-Barat.

"The meeting should have been avoided, but it was notand others may have to pay for it," Pawar said referring to the religious meeting in the national capital.

He said the "possibility of some people who attended the meeting carrying the disease cannot be ruled out" and pressed for maintaining discipline given the situation caused by the COVID-19 outbreak.

"Shab-e-Barat is on April 8. Muslims remember their relatives, who are not more, by visiting kabrastan (graveyard). It should be observed inside home. Precaution should be taken to see there is no repeat of the Nizamuddin meeting-like episode," he said.

The birth anniversary of Ambedkar, the architect of the Indian Constitution, is observed on April 14.

Pawar said people should also think about postponing Ambedkar's birth anniversary celebrations.

"We normally celebrate it (the anniversary) for two or so months. We should think whether we should really observe the programme at this juncture (given the coronavirus threat).

If we come together, we may have to face health issues," the former Union minister said.

He said in general, 90 per cent people have been observing the lockdown, but 10 per cent are not doing so.

The Centre and the Maharashtra government may have to extend the lockdown period if discipline is not observed till April 14 (till when the lockdown is in force), he said, urging people to toe the line in the interest of each other.

Pawar also praised Chief Minister Uddhav Thackeray, the state administration and police for working round-the- clock, and asked people to cooperate with them by staying at home.