Sidhu should stay in Pakistan: Sukhbir Badal

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, Jun 16: With an increase of 10,667 cases and 380 deaths in the past 24 hours, the COVID-19 count in India has reached 3,43,091 on Tuesday, according to the Union Health and Family Welfare Ministry.

It is noteworthy that today's spike in cases is lower than the 11,502 registered in the country yesterday and has also stayed below the 11 thousand mark it had been crossing for the past two days in a row.

However, there is an increase in the number of deaths due to the infection from yesterday, with 380 deaths being reported from across the country, the toll due to COVID-19 has now reached 9,900.

The COVID-19 count includes 1,53,178 active cases, while 1,80,013 patients have been cured and discharged or migrated so far.

Maharashtra with 1,10,744 cases continues to be the worst-affected state in the country with 50,567 active cases while 56,049 patients have been cured and discharged in the state so far. The toll due to COVID-19 has crossed the four thousand mark and reached 4,128 in the state.
It is followed by Tamil Nadu with 46,504 and the national capital with 42,829 confirmed cases.

Apr 24: Kerala Chief Minister Pinarayi Vijayan on Friday sought Prime Minister Narendra Modi's intervention in bringing bodies of Keralites who died in the Gulf countries due to non-COVID-19 reasons to the state without any delay for performing last rites in their home towns.

In a letter, he wanted Modi to direct Indian embassies to issue necessary clearances without seeking individual approvals from the Ministry of Home Affairs and avoid any delay so that the remains reach Kerala early. It has been learnt that a 'clearance certificate' from the Indian embassies concerned was required to process the application for bringing home the bodies.

The embassies are insisting on production of no-objection certificate from the Union Ministry of Home Affairs, he said in the letter, a copy of which was released to the media here on Friday. The Centre had already agreed that in case the deaths are not COVID related, such certificates are not necessary.

The bodies are now being brought in the cargo planes as passenger flights are not being operated due to the lockdown. Chief Minister said he had received several grievances from the NRKs in Gulf Cooperation Council (GCC) countries on the delay in bringing home the bodies of those who died there. "They are already under tremendous stress and anxiety due to the lockdown imposed in those countries and the consequent stoppage of international flights", Vijayan said.