India, US renew defence pact; to pursue co-production projects

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 9: The Centre and the Delhi government are working in close coordination to deal with coronavirus, Chief Minister Arvind Kejriwal said here on Monday.

Talking to reporters after a review meeting with Union Health Minister Harsh Vardhan on the preparedness for COVID-19, the chief minister said people arriving from foreign countries are being screened at airports.

A campaign will be run to make people aware of the preventive measures to contain the spread of the disease, Kejriwal said.

Health Ministry sending directives to states: Vardhan

Health Minister Harsh Vardhan said the government is prepared to deal with novel coronavirus and his ministry is sending directives, including guidelines, to states in all the languages on ways to contain it.

"We are sending detailed guidelines to all states on ways to contain coronavirus. Have asked states to strengthen laboratories and manpower to effectively deal with coronavirus and form early rapid action teams," Vardhan told reporters adding, that the government is prepared to deal with the infection.

Vardhan stressed on a coordinated action between all concerned departments and agencies for activities such as contact tracing, community surveillance, hospital management, identification of isolation wards, ensuring adequate personal protection equipment and masks and risk communication for mass awareness.

New Delhi, May 1: The Centre has finalsed the criteria for delimitation of various zones after May 3. It has identified at least 130 districts as red zones, 284 orange zones and 319 green zones.

According to a letter written by Health Secretary Preeti Sudan to the Chief Secretaries of all States and UTs, all the states have to delineate the containment areas and buffer zones in the identified red and orange zone districts and notify the same.

The letter said, the national capital has at least 11 red zones, Uttar Pradesh 19 red zones, 36 orange zones and 20 green zones while, the state of Haryana has 2 red zones, 18 orange zones and 2 green zones.

The Gautam Buddha Nagar in Uttar Pradesh has been identified as a red zone district while, Ghaziabad has been designated as an orange zone. The national capital has no orange and green zone; there are only red zones according to the letter.

In Maharashtra, Mumbai, Pune, Thane, Nashik come in the red zone.

In West Bengal, Kolkata, Howrah, 24 Parganas -- both North and South have been identified as red zones while Hooghly, Nadia, Murshidabad etc have been marked as orange zones.

In the southern part of India, Kerala has 2 red zones and 10 orange zones, while Tamil Nadu has 12 red zones and 24 orange zones.

The Health Secretary said that the list will be revised on a weekly basis or earlier and communicated to states for further follow-up action in consonance with the directions issued by the Ministry of Home Affairs under the Disaster Management Act, 2005 based on field feedback and additional analysis at state level, states may designate additional red or orange zones as appropriate.

However, states may not relax the zonal classification of districts classified as red or orange as communicated by the Ministry. This classification is multi-factorial and takes into consideration incidence of cases, doubling rate, extent of testing and surveillance feedback to classify the districts.

A district will be considered under green zone, if there are no confirmed cases so far or there is no reported case since the last 21 days in the district.