Visa issue unlikely to impact India-US ties: Indian expert

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, Apr 6: With an increase of 490 cases in the last 12 hours, the total number of COVID-19 positive cases in India climbed to 4067, said Ministry of Health and Family Welfare on Monday.

As many as 109 deaths have been reported across the country due to the deadly disease.
There are 3666 active cases in the country while 292 people have been cured/discharged/migrated.

Maharashtra has reported the highest number of COVID-19 cases so far, standing at 690, followed by Tamil Nadu and Delhi with 571 and 503 cases respectively. 

Vishakhapatnam, May 15: LG Chem on Thursday said following the gas leak at its Visakhapatnam polymers plant, the company has started support measures and has begun the transportation of the Styrene Monomer inventory to South Korea to eliminate all risks factors.

The company would continue to work with government agencies to ensure all possible support for bereaved families and victims, LG Polymers, a step-down firm of LG Chem, said in a statement.

"We confirm the status-quo of the plant remains completely controlled by all measures. We have begun the transportation of the Styrene Monomer (SM) inventory within the plant as well as in the styrene tanks at the port by vessels to South Korea to prevent and eliminate all risks factors," the statement said.

The South Korean chemicals giant has sent an eight-member team from Seoul to investigate the Visakhapatnam gas leak incident and rehabilitate the victims of the tragedy that killed at least 11 people and forced the evacuation of thousands.

"The team of production, environment, and safety experts are currently investigating the cause of the incident and already supporting responsible rehabilitation which is their main objective," the statement said.

Furthermore, the team is working closely with related authorities to analyze the cause of the incident, prevent a recurrence, and support damage recovery in a prompt and expedient manner, it added.

On the support measures, the company said a special task force is currently supporting the bereaved victims and families and visiting them at the hospitals and their homes.

Besides, food and medical services have been organized for the returning residents. Various support activities such as supplying medical and household goods and sanitation of homes will be continued, it said.

"We assure everyone we will do our best to resolve the situation and prevent any incident in the future," the company said.

The company further said that "our teams will carry out mid-to-long-term Corporate Social Responsibility (CSR) projects that can contribute to the local community based on suggestions of the residents.