Tremors in Gujarat, Maharashtra

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.

Singapore, Jun 2: Moody's Investors Service on Tuesday downgraded 11 Indian banks along with as many non-financial companies and infrastructure majors besides four government-related issuers following a downgrade of the Indian government's issuer rating to Baa3 from Baa2 with a negative outlook.

The rapid and widening spread of the coronavirus outbreak, deteriorating global economic outlook, volatile oil prices and asset price declines are creating a severe and extensive credit shock across many sectors, regions and markets, said Moody's.

The Indian banking sector has been affected given the disruptions to India's economic activity from the coronavirus outbreak, which is weakening borrowers' credit profiles, it added.

The 11 lenders include Bank of Baroda, Bank of India, Canara Bank, Central Bank of India, Export-Import Bank of India, HDFC Bank, Indian Overseas Bank, IndusInd Bank, Punjab National Bank, State Bank of India and Union Bank of India.

The 11 non-finance companies are Oil and Natural Gas Corporation, Hindustan Petroleum Corporation, Oil India, Indian Oil Corporation, Bharat Petroleum Corporation, Petronet LNG, Tata Consultancy Services, Infosys, Reliance Industries, UPL Corporation and Genpact.

The 11 infrastructure companies are NTPC, NHPC, National Highways Authority of India, Power Grid Corporation, Gail India, Adani Green Energy Restricted Group (RG-2), Adani Transmission Restricted Group, Adani Ports and Special Economic Zone, Adani Transmission, Adani Electricity Mumbai and Azure Power Solar Energy.

The four Indian government-related issuers are Indian Railway Finance Corporation, Housing and Urban Development Corporation, Power Finance Corporation and REC Ltd.

"Government-related issuers in India have been affected because of disruptions to India's economy which will weaken borrowers' credit profiles," said Moody's.