Modi govt slammed for misleading families of missing Indians

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.

Kolkata, Jun 24: Trinamool Congress (TMC) MLA Tamonash Ghosh, who had tested positive for Covid-19 in May, died at a hospital here on Wednesday, party sources said.

He was 60.

The three-time MLA from the Falta assembly constituency in South 24 Parganas district was admitted to a hospital after he tested positive for the disease, they said.

He had several complications related to the heart and the kidney, the sources said.

"Very, very sad. Tamonash Ghosh, 3-time MLA from Falta & party treasurer since 1998 had to leave us today. Been with us for over 35 years, he was dedicated to the cause of the people & party. He contributed much through his social work," West Bengal Chief Minister and TMC supremo Mamata Banerjee tweeted.

"He has left a void that will be difficult to fill. On behalf of all of us, heartfelt condolences to his wife Jharna, his two daughters, friends and well-wishers," she added.

India is among 58 nations, including 27 European Union members, who have moved a draft resolution demanding evaluation of the World Health Organisation (WHO)'s response towards the novel coronavirus pandemic.

The European Union-led draft resolution on global COVID-19 response is set to be tabled at the upcoming World Health Assembly on Monday.

The draft resolution demands initiation "at the earliest appropriate moment to review experience gained and lessons learned from the WHO-coordinated international health response to COVID-19".

"We are deeply concerned by the morbidity and mortality caused by COVID-19 pandemic, the negative impacts on physical and mental health and social well-being, the negative impacts on economy and society and the consequent exacerbation of inequalities within and between countries," read the draft.

"We express solidarity to all countries affected by the pandemic, as well as condolences and sympathy to all the families of the victims of COVID-19," it added.

The resolution says timelines are to be evaluated regarding "recommendations the WHO made to improve global pandemic prevention, preparedness, and response capacity".

The WHO on January 23 declare a global health emergency, but did not declare it and waited for a week for its director-general Tedros Adhanom Ghebreyesus to return from China.

By that time, COVID-19 cases increased 10 times and the virus entered 18 countries.

According to Health Policy Watch, till as late as February, the WHO did not support countries for imposing travel restrictions to China.

"When countries began evacuating their citizens from Wuhan, the COVID-19 epicentre, the WHO said it did not favour this step".

The WHO finally declared it a pandemic on March 11.

The global health body has come under criticism not just from the US for its response being "China-centric".