DGCA grounds Vistara pilot who issued 'Mayday call'

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.

Mumbai, May 14: The Shiv Sena on Thursday raised questions over the Centre's Rs 20 lakh crore stimulus package announced to revive the COVID-hit economy, and asked if India is not a "self-reliant" country at present.

An editorial in Sena mouthpiece 'Saamana' wondered how Rs 20 lakh crore will be raised, and opined that an environment needs to be created where industrialists, trade and business sectors are encouraged to invest.

On the path of new self-reliance, India cannot afford industrialists running away, and for that "political institutions like the ED and CBI need to be put in lockdown for some time," it said.

Prime Minister Narendra Modi on Tuesday announced new financial incentives on top of the previously announced packages for a combined stimulus of Rs 20 lakh crore, saying the COVID-19 crisis has provided India an opportunity to become self-reliant and emerge as the best in the world.

The Sena said the country is being told that the package will be beneficial for MSMEs (micro, small and medium enterprises), poor labourers, farmers and the tax-paying middle class.

"The package (as per the Centre) will reach 130 crore Indians and the country will become self-reliant. Does this mean India is not a self-reliant country at present?" the Marathi daily asked.

It is good that PPE kits and N95 masks are now being manufactured in India, it said.

"Any country progresses ahead while learning from crisis and through struggle. Before Independence, not even a needle was manufactured in India but in 60 years, India became self-reliant in science, technology, agro business, defence, manufacturing and atomic science," it said.

An institution like the Indian Council of Medical Research (ICMR), which is helping in the manufacturing of PPE kits, is part of the self-reliant India, it noted.

Wondering how Rs 20 lakh crore, as announced in the central package, will be raised, the Sena said an "environment needs to be created where industrialists, trade and business sectors will be encouraged to invest".

"India, on path of new self-reliance, cannot afford industrialists running away, and for that political institutions like the Enforcement Directorate (ED) and the Central Bureau of Investigation (CBI) need to be put in lockdown for some time," the paper said.

Despite announcing the 'lockdown-4' and the economic package, why its impact has not been reflected in the share market? it asked.

"Investors are in a dilemma. The prime minister and chief ministers must show them trust and support," it said.

"Earlier it was Pandit Nehru and now it is Modi. If (former prime minister) Rajiv Gandhi had not laid the foundation of a digital India, there wouldn't be video conference of PM, CMs and bureaucracy in times of coronavirus," the Uddhav Thackeray-led party said.

It agreed with Modi that coronavirus will stay for long, and lives need not revolve around it.

"We need to get back on our feet again," the Sena said.

Visakhapatnam, Jun 13: A four-month-old baby who was on ventilator treatment for 18 days for COVID-19 was on Friday evening discharged from hospital after testing negative.

"A tribal woman of East Godavari named Laxmi was infected with COVID-19 in May, later the doctors confirmed that her four-month-old baby was also infected," said District Collector, Vinay Chand.

"The baby was shifted to Visakhapatnam VIMS hospital on May 25. She was treated for 18 days on a ventilator. Doctors again conducted baby's COVID-19 test recently, following which the reports came negative. After a health check-up, VIMS doctors discharged the baby on Friday evening," he added.

Meanwhile, 14 new COVID-19 positive cases have been reported in Visakhapatnam district on Friday, taking the total number of cases to 252 including one fatality due to the virus.