India country of Hindus first, others later: Sena

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, Mar 5: Union Health Minister Harsh Vardhan assuring that the government has the coronavirus crisis under control, is like the Titanic captain telling passengers not to panic as his ship was unsinkable, Congress leader Rahul Gandhi said on Thursday.

Gandhi's remarks came after Vardhan's assurance in Parliament that the government is taking all necessary measures to prevent the spread of COVID-19 (coronavirus disease) in India.

“The health minister saying that the Indian government has the coronavirus crisis under control, is like the Captain of the Titanic telling passengers not to panic as his ship was unsinkable,” Gandhi said in a tweet.

“It's time the government made public an action plan backed by solid resources to tackle this crisis,” he said.

RMS Titanic was a British passenger liner that sank in the North Atlantic Ocean in the early morning hours of April 15, 1912, after striking an iceberg during her maiden voyage from Southampton to New York.

Gandhi has been raising concerns over the coronavirus infection since long. In a February 12 tweet, he had said coronavirus is an extremely serious threat to “our people and our economy”.

“My sense is the government is not taking this threat seriously. Timely action is critical,” he had said.

Earlier this week, Gandhi had hit out at Prime Minister Narendra Modi over the detection of fresh coronavirus cases in the country, saying he should quit wasting India's time “playing the clown” with his social media accounts when India is facing an emergency.

With the message of “Here's how it's done”, Gandhi had also tweeted a video of Singaporean Prime Minister Lee Hsien Loong addressing Singaporeans on how to deal with the coronavirus.

The number of coronavirus cases in India is 29, including 16 Italians, the government had said on Wednesday, adding all international passengers will now be screened at airports, amid growing concern over the spread of the respiratory infection.

New Delhi, Jun 28: Home Minister Amit Shah on Sunday targeted former Congress President Rahul Gandhi, saying he was indulging in "shallow-minded" politics and making statements that make Pakistan and China happy when soldiers are fighting a spirited battle.

Shah said the government is ready for a discussion in Parliament about the situation from 1962 (when India-China war took place) and it is sad that a former president of a party making statements, which are being celebrated in Pakistan and China.

The Home Minister's comments came during an interview with ANI when he was asked about Rahul's "Surrender (Prime Minister Narendra) Modi" remarks while criticising the BJP-led government on India-China border row.

Rahul has been consistent in his criticism of the government on the handling of both Covid-19 situation and India-China border row, which escalated into a "violent face-off" earlier this month in which 20 Indian soldiers were killed.

"Let there be a robust debate in Parliament. Let us have one. Let us discuss from 1962. Nobody is scared of debate. But one should not make a statement that makes Pakistan and China happy when the soldiers are fighting a spirited battle and the government is taking strong steps," he said.

Asked whether India can handle the anti-India propaganda unleashed by Rahul's 'Surrender Modi' hashtag, he said the government is capable of handling it but it is a matter of introspection for the former Congress president and his party that their remarks are being used against the country.

Modi's remarks at an all-party meeting that no one has intruded into Indian territory triggered a controversy with a section arguing that it went against the previous statement of External Affairs Minister S Jaishankar.

Claiming that he could not advise Rahul as it is Congress' job to do so, he said the government has fought Covid-19 well but some people have a twisted way of seeing things. He said India fought well against Covid-19 and the statistics will speak for itself as it is much better compared to the world.

Shah said under Modi's leadership, India is going to win both the battles -- Covid-19 and India-China border row.

The Home Minister also refused to be drawn into a question on whether Chinese soldiers are holding on to Indian territory on the border at present, saying the government is doing enough to address border row with China.

"I don't want to do anything that goes against my primary aim of this interview (to highlight the steps taken to fight Covid-19 pandemic in Delhi) and create headlines that keep citizens further in fear," Shah said.

When pointed out that people are also in panic due to the border situation, he said the government has taken steps to address the situation and at an appropriate time he would make comments, if needed.

Asked about his tweets on Emergency, which was targeted by Congress asking whether there is democracy in the BJP, he countered it saying that BJP has presidents L K Advani followed by Rajnath Singh, Nitin Gadkari, Rajnath again, himself and now J P Nadda.

"After Indira-ji, was there any Congress President from outside Gandhi family? What democracy do they talk about? I did not do any politics during Covid-19. You look at my tweets of the past 10 years. Every June 25, I give a statement," he said.

"Emergency should be remembered by people as it attacked the roots of our democracy. No one should ever forget it. There should be awareness about it. It is not about a party but about the attack on the country's democracy," he said.