BJP leader Jyotiraditya Scindia and his mother test COVID-19 positive

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.

Noida, May 6: Not having Aarogya Setu app on smartphone while out in public in Noida or Greater Noida will be considered a violaton of lockdown rules and the person will be punished.

Action will also be taken against people going outdoors without a face mask or spitting in public places, Gautam Buddh Nagar police said, news agency reported.

Aarogya Setu is a mobile application developed by the central government to connect essential health services with the people to fight Covid-19.

The app is aimed at augmenting the initiatives of the Centre, particularly the Department of Health, in proactively reaching out to and informing the users of the app regarding risks, best practices and relevant advisories pertaining to the containment of Covid-19.

"If smartphone users do not have the 'Aarogya Setu' app installed on their mobile phones, then that will be punishable and considered a violation of the lockdown directions," Additional Deputy Commissioner of Police, Law and Order, Ashutosh Dwivedi said.

The district police had on Sunday announced extending the Criminal Procedure Code section 144, which bars assembly of four or more people, till May 17, as the central government extended the nationwide lockdown by another two weeks in a bid to check the spread of the virus.

"Spitting in public places will attract punishment along with a fine. Not wearing a face mask in public places or offices will also be a punishable offence.

During the lockdown period, political, social, religious, sports gatherings as well as protest marches and rallies will remain banned across Noida and Greater Noida, the official said in the order.

"The central government has extended the lockdown till May 17 in view of the coronavirus pandemic. Gautam Buddh Nagar has been identified as 'red zone' and hotspots have been identified here. During this duration, all guidelines of the lockdown are to be followed," he said.

Gautam Buddh Nagar, which falls in the 'Red Zone', has 34 containment zones and has recorded 179 positive cases of coronavirus so far, with 102 of these patients being cured and discharged from hospitals, according to official figures.

Jan 27: Bidders for Air India Ltd. will need to absorb $3.26 billion of its debt, as Prime Minister Narendra Modi’s administration tries once again to sell the national carrier.

The entire company will be sold but effective control needs to stay with Indian nationals, according to preliminary terms published Monday. Bids are invited by March 17 with Ernst & Young LLP India as transaction adviser.

Air India, which started in 1932 as a mail carrier before winning commercial popularity, saw its fortunes fade with the emergence of cutthroat low-cost competition. The state-run airline has been unprofitable for over a decade and is saddled with more than $8 billion in debt.

Indian regulations allow a foreign airline to buy as much as 49% of a local carrier, while overseas investors other than airlines can buy an entire carrier. The government didn’t find a single bidder when it tried to sell Air India in 2018.