SC crisis: BCI delegation meeting SC judges

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.

Thiruvananthapuram, May 24: Keralites on Sunday celebrated a low-key Eid-ul-Fitr amid the coronavirus lockdown in the state as most of the faithful marked the culmination of the fasting month of Ramzan by offering thanksgiving prayers at home.

The festival is being celebrated across Kerala and Jammu and Kashmir on Sunday, while the rest of the country will celebrate Eid on Monday.

Kerala Chief Minister Pinarayi Vijayan extended Eid-ul-Fitr greetings to all Keralites across the world.

State Governor Arif Mohammed Khan also extended his festival wishes to all the Keralites.

"May we also have the blessing to prevent and eliminate the COVID-19 disease," Khan tweeted.

Vijayan said this year Ramzan is celebrated at a time when the world is going through "an unprecedented crisis and misery" because of pandemic COVID-19.

"Usual celebration during Ramzan is not there anywhere in the world due to the pandemic. Instead of offering prayers at mosques, which is important for Muslims, this time the prayers and the feast is performed in their homes.

Community leaders have taken this important decision to protect the interests of the society" he added.

The chief minister said Eid-ul-Fitr gives out a message of equality, tolerance and repentance.

The state government had earlier announced that the lockdown restrictions in the state onSunday will be relaxed in the view of Eid-ul-Fitr with shops selling essential items remaining open.

The State government had earlier declared that a complete shutdown would be observed in Kerala on Sundays in order to contain the spread of the deadly virus.