Lalu returns to Patna to surrender before CBI

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 19: RJD and AAP were not invited to the all-party meeting called by Prime Minister Narendra Modi on Friday to discuss the situation at the India-China border after 20 Indian soldiers were killed in a "violent face-off," leaving the parties fuming.

Top RJD leader Tejashwi Yadav criticised the government for not inviting the party to the meeting, asking on Twitter late Thursday night, "Just wish to know the criteria for inviting political parties for tomorrow's (Friday's) all-party meet on Galwan Valley. I mean the grounds of inclusion/exclusion. Because our party hasn't received any message so far."

AAP's Rajya Sabha leader Sanjay Singh joined the chorus, "there is a strange ego-driven government at the centre. AAP has a government in Delhi and is the main opposition in Punjab. We have four MPs. But on a vital subject, AAP's views are not needed? The country is waiting for what the Prime Minister will say at the meeting."

Sources said the government has set a criteria to invite only parties with five or more MPs in Parliament for the digital meet, where the Prime Minister will brief the top leaders of parties and hear their views on the way ahead. There are at least 27 parties in the Parliament, which have less than five members, while 17 have more than five members or more than five MPs.

Interestingly, RJD has five MPs in Rajya Sabha and its senior MP Manoj K Jha shared the Rajya Sabha website link on Twitter, which showed the party has five MPs. "We have not been invited and the government's bogus argument has been exposed," Jha said.

CPI leaders said General Secretary D Raja received a call from Defence Minister Rajnath Singh inviting him to the meeting and with a message that the Prime Minister's Office would coordinate but there was no follow-up after that.

"Exclusion of AAP and RJD in the all-party meet on a National debate does not augment well. AAP is ruling Delhi and has its CM. Why should people of Delhi be kept out in such an important debate on National integrity and Sovereignty?" former NCP MP Majeed Memon tweeted.

During the all-party meeting on COVID-19 too, the government had not called all parties with representation in Parliament to the all-party meeting in April and had set five MPs as a benchmark to be invited.

Raja had then written a letter to Modi demanding that the government should not get into "technicalities" and discuss the issue with all parties in Parliament.