Varavara Rao tests coronavirus 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.

Kochi, May 28: In these pandemic times, when the businesses are gravely affected and the MSMEs are particularly feeling the heat, a Kerala institute has come up with an initiative to help the distressed industry. The Institute of Small Enterprises and Development (ISED) has come out with a unique platform -- 'business clinic' for extending advisory services to the COVID-19 affected MSMEs in the state.

The Kochi based ISED's multi-disciplinary team of experts will offer free guidance to entrepreneurs to make a self-evaluation for improving their performance.

It will serve the interests of the MSMEs, entrepreneurial aspirants, such as the returning migrants, start-ups, educated unemployed, and women entrepreneurs.

ISED director, PM Mathew said COVID-19 pandemic has shattered the budgets and operations of most SMEs, globally, as also in India.

"Post-lockdown, the operational problems are likely to get aggravated. Beyond the broad macro level projections and debates, it is now time to act at the grassroots level. Many entrepreneurs need appropriate clinical assessment, and moral and psychological support, said Mathew.

According to the work force participation data at the national level, Kerala is ranked 31 in terms of the number of self employed, and placed in second rank in relation to the size of casual labour.

The Kerala Enterprise Development Report, brought out by the ISED states while the number of the unregistered enterprises is sizeable, constituting 76.85 % of the total, the respective share of registered MSMEs is only 9.53 %.

The constraints to these enterprises today are, poor sales, large inventory, delayed payments, damage of stock, wage bill arrears, unreliable labour supplies, fund diversion due to exigencies, GST related problems, and NPA/poor credit score.

"For all businesses, unlike in a sporadic recession in the economy, the danger today is circular and cumulative. Both from the demand side, and the supply angle, there is a serious contraction of business activities, which essentially means a glut in the cash flow. Corporate businesses, obviously, will come out of the mess due to their relative advantages of high reserve funds, liberal credit offerings, and easier access to alternative sources of finance," said Mathew.