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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, Jul 1: The United States has approved four coronavirus vaccine candidates for clinical trials, Food and Drug Administration (FDA) head Stephen Hahn told reporters.

"Four vaccines have been approved for moving into clinical trials... and another six are in the pipeline for us to review," Hahn said during a press briefing on Tuesday.

The US Administration launched in May Operation Warp Speed, a joint project of Health and Defense Departments, which aims to deliver 300 million doses of a vaccine for COVID-19 by January 2021.

The country's top pandemics expert Anthony Fauci warned on Tuesday, however, that there is no certainty the United States will be able to develop a vaccine against COVID-19 that works and will be safe.

Data on vaccine effectiveness, he added, may be available in the winter or early next year.

Mumbai, Feb 2: Kerala Chief Minister Pinarayi Vijayan on Sunday slammed the BJP-led central government on the Citizenship Amendment Act (CAA) and said that the new law only serves the objectives of the Sangh Parivar of turning India into a Hindu Rashtra.

He said that in order to achieve their objectives, the "communal elements" are trying to divide India's people through the same strategy as employed by the British colonisers in the past.

Lauding people in Mumbai for their protests against CAA, the National Register of Citizens (NRC) and the National Population Register (NPR), the Kerala chief minister also outlined three reasons for his government's decision to reject the Citizenship Amendment Act.

"Over the last several weeks, Mumbai citizens made clear their unyielding opposition to efforts made by Hindutva elements to tear apart the secular fabric of our society. I express solidarity with struggles being made across the city in defence of secularism and the Indian Constitution," Vijayan said at an event here.

The chief minister was addressing the 'Mumbai Collective' here on the topic of 'National struggle against communalism'.

"The government of Kerala is acting as per the Constitution. Like Kerala, other states are also looking at CAA as against the fundamentals of the Constitution. It (CAA) violates basic human rights and is divisive and deeply discriminatory," CM Vijayan said, adding that the new citizenship law only furthers the Sangh Parivar's objective of creating a Hindu Rashtra.

He said the CAA needs to be rejected for three basic reasons.

"First, it is against the letter and spirit of our Constitution. Secondly, it is highly discriminatory and violative of human rights. Thirdly, it seeks to impose philosophy of Sangh Parivar with its mission of Hindu Rashtra," the chief minister said.

Vijayan also participated in the human chain organised by Left Democratic Front (LDF) against CAA and NRC and said that "the law is a threat to the secularism of this country".

The newly enacted law is facing stiff opposition across the country with several non-NDA states including Kerala, West Bengal, Rajasthan and Punjab refusing to implement it.

Rajasthan, Kerala and Punjab have passed resolutions against the recently amended law in their respective state Assemblies.

The CAA grants citizenship to Hindus, Sikhs, Jains, Parsis, Buddhists and Christians fleeing religious persecution from Pakistan, Afghanistan and Bangladesh and who came to India on or before December 31, 2014.