Serum Institute of India gets nod for phase 2,3 trials of Oxford covid vaccine

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.

United Nations, Jun 6: The COVID-19 pandemic, which has presented challenges for several nations, could be an “opportunity” for India to speed up the health insurance scheme Ayushman Bharat, especially with a focus on primary healthcare, WHO chief Tedros Adhanom Ghebreyesus has said.

WHO Director-General Ghebreyesus was responding to a question on the COVID-19 situation in India, where the number of coronavirus cases are increasing rapidly. India went past Italy on Friday to become the sixth worst-hit nation by the COVID-19 pandemic.

India saw a record single-day jump of 9,887 coronavirus cases and 294 deaths on Saturday, pushing the nationwide infection tally to 2,36,657 and the death toll to 6,642, according to the health ministry.

"Of course COVID is very unfortunate and it's challenging for many nations but we need to look for opportunities too. For instance for India, this could be an opportunity to speed up Ayushman Bharat, especially with a focus on primary health care. I know there is a very strong commitment from the government to speed up the implementation of Ayushman Bharat and with primary healthcare and community engagement, I think we can really turn the tide,” Ghebreyesus said during a press briefing in Geneva on Friday.

Ayushman Bharat is the world’s largest health insurance scheme and was launched by the Narendra Modi government in 2018. Last month, Modi had said that the number of people who have benefited from the scheme crossed the one crore-mark.

The scheme aims to cover more than 500 million beneficiaries and provide coverage of Rs 500,000 per family per year.

Referring to the Ayushman Bharat scheme, Ghebreyesus added that “using and speeding up what has started could actually help in India and that's what WHO was very appreciative by the way when Ayushman Bharat started. And this could be a very good opportunity actually to test that and speed up and use it to really fight this pandemic.”

Jaipur, Jan 27: Senior Congress leader Shashi Tharoor said that if the Citizenship Amendment Act leads to the implementation of the NPR and the NRC, it would be a complete victory for Pakistan's founding father, Muhammad Ali Jinnah.

He said that Jinnah's idea of a country was already winning in India with the contentious Citizenship Amendment Act (CAA) coming into effect, but asserted that there was still a choice available.

"I would not say Jinnah has completely won, but I would say Jinnah is winning. There is still a choice available to the nation between Jinnah's idea of a country and Gandhiji's idea of a country," he said on the sidelines of the Jaipur Literature Festival on Sunday.

The CAA came into force in India in December amid protests across the country and around the world.

The MP from Thiruvananthapuram said that the amended Citizenship Act took Jinnah's logic by declaring that religion shall be the basis of nationhood, reaffirming that Gandhi's idea is that all religions are equal .

"The CAA is, if you are talking Tennis, you would say one set up or big first set lead for Jinnah. But the next step would be if the CAA would lead to the National Population Register (NPR) and the National Register of Citizens (NRC). If that happens, then you would consider that Jinnah's victory is complete," he said.

The CAA seeks to grant citizenship to migrants belonging to Hindu, Sikh, Buddhist, Christian, Jain and Parsi communities who came to India from Pakistan, Bangladesh and Afghanistan on or before December 31, 2014.

On the BJP's defence that the NPR was carried out during the UPA regime, Tharoor said that the Congress government had utilised a decision of the NDA government led by former prime minister Atal Bihari Vajpayee.

"It never asked where were your parents born. It never authorised the enumerators to note on the margin 'dubious citizenship', a term used in the NPR rules crafted by this government. That is purely BJP's invention," he said.

If we go around this country authorising people to interview all the citizens, or identify some who have 'dubious citizenship', you can be pretty sure which Indians are going to be found on the 'dubious citizenship', he said.

"That will principally be one community that is not mentioned in the CAA. And if that happens, then it is indeed Jinnah's victory.

"From wherever he is, he can point to this place and say, 'see I was right in the 1940. We are separate nations and Muslims deserved their own country because Hindus cannot be just'," Tharoor said.

Speaking about the Delhi election, the three-time MP said that the maximum development in the national capital happened under the Congress government.

"What Sheila Dikshit did in her 15 years as Chief Minister of Delhi, no other leader could do it before or after her," he said.