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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.

Washington, Jun 30: Researchers in China have discovered a new type of swine flu that is capable of triggering a pandemic, according to a study published Monday in the US science journal PNAS.

Named G4, it is genetically descended from the H1N1 strain that caused a pandemic in 2009.

It possesses "all the essential hallmarks of being highly adapted to infect humans," say the authors, scientists at Chinese universities and China's Center for Disease Control and Prevention.

The researchers then carried out various experiments including on ferrets, which are widely used in flu studies because they experience similar symptoms to humans -- principally fever, coughing and sneezing. 

G4 was observed to be highly infectious, replicating in human cells and causing more serious symptoms in ferrets than other viruses.

Tests also showed that any immunity humans gain from exposure to seasonal flu does not provide protection from G4.

According to blood tests which showed up antibodies created by exposure to the virus, 10.4 percent of swine workers had already been infected.

The tests showed that as many as 4.4 percent of the general population also appeared to have been exposed.

The virus has therefore already passed from animals to humans but there is no evidence yet that it can be passed from human to human -- the scientists' main worry.

"It is of concern that human infection of G4 virus will further human adaptation and increase the risk of a human pandemic," the researchers wrote.

The authors called for urgent measures to monitor people working with pigs.

"The work comes as a salutary reminder that we are constantly at risk of new emergence of zoonotic pathogens and that farmed animals, with which humans have greater contact than with wildlife, may act as the source for important pandemic viruses," said James Wood, head of the department of veterinary medicine at Cambridge University.

A zoonotic infection is caused by a pathogen that has jumped from a non-human animal into a human.