Raj Thackeray remark: Nitish slams Centre, Maharashtra govt

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 20: Prime Minister Narendra Modi on Monday appealed to state governments to ensure that rules and regulations of the coronavirus lockdown are enforced as he noted that many people are not taking the measure seriously.

"Many people are still not taking the lockdown seriously. Please save yourself, save your family, follow the instructions seriously. I request state governments to ensure rules and laws are followed," he said in a tweet in Hindi.

The Centre and state governments have decided to completely lock down 80 districts across the country where coronavirus cases have been reported.

Uttar Pradesh, Maharashtra, Punjab, Karnataka, Tamil Nadu and Kerala announced lockdown in many districts.

Delhi will be locked down from 6 am on March 23 till midnight on March 31.

New Delhi, Apr 15: As the world grapples with coronavirus, researchers have found the presence of a different kind of coronavirus -- bat coronavirus (BtCoV) --in two bat species from Kerala, Himachal Pradesh, Puducherry and Tamil Nadu, according to a study by the Indian Council of Medical Research (ICMR).

There is no evidence or research to claim that these bat coronaviruses can cause disease in humans, said Dr Pragya D Yadav, Scientist at the National Institute of Virology (NIV), Pune and also the first author of study.

The study has been published in the Indian Journal of Medical Research,

Twenty-five bats of Rousettus and Pteropus species from Kerala, Himachal Pradesh, Puducherry and Tamil Nadu were found positive for BtCoV in Kerala, Himachal Pradesh, Puducherry and Tamil Nadu.

"These bat coronaviruses have no relation with SARS-CoV2 responsible for the COVID-19 pandemic," Yadav said, adding that Pteropus bat species were earlier found positive for Nipah virus in 2018 and 2019 in Kerala.

"Bats are considered to be the natural reservoir for many viruses, of which some are potential human pathogens. In India, an association of Pteropus medius bats with the Nipah virus was reported in the past. It is suspected that the recently emerged severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) also has its association with bats," the objective of the study titled 'Detection of coronaviruses in Pteropus and Rousettus species of bats from different states of India' stated.

"In the present scenario of changing demography and ecological manipulations, it is challenging to have checks on the encounters of bats with other animals and humans," the study stated, highlighting that the need for active and continuous surveillance remains crucial for outbreak alerts for bat-associated viral agents with epidemic potential, which would be helpful in timely interventions.

"Although CoVs in the subfamily coronavirinae do not usually produce clinical symptoms in their natural hosts (bats), accidental transmission of these viruses to humans and other animals may result in respiratory, enteric, hepatic or neurologic diseases of variable severity. It is still not understood as to why only certain CoVs can infect people," the study said.

The scientists stressed on the need of proactive surveillance of zoonotic infections in bats.

The detection and identification of such viruses from bats also recommends cross-sectional antibody surveys (human and domestic animals) in localities where the viruses have been detected.

Similarly, if the epidemiological situation demands, evidence-based surveillance should also be conducted, the study said while emphasing on the need of developing strong mechanisms for working jointly with various stakeholders such as wildlife, poultry, animal husbandry and human health departments.

"In conclusion, our study showed detection of bat CoVs in two species of Indian bats. Continuous active surveillance is required to identify the emerging novel viruses with epidemic potential," Dr Yadav said.

Elaborating on the study, Dr Yadav said throat and rectal swab samples of two bat species -- Rousettus and Pteropus -- from seven states were screened for the bat coronvirus during which the representative samples collected from Kerala, Himachal Pradesh, Puducherry and Tamil Nadu tested positive while those from Karnataka, Chandigarh, Punjab, Telengana, Gujarat and Odisha came out negative.

The reverse-transcription polymerase chain reaction (RT-PCR) tests and sequencing were used for the confirmation of the findings.

"This is an ongoing study to understand the prevalence of the Nipah virus in bats," she said.