VP Naidu warns Pak: India can give reply if attacked

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.

The Ministry of Health and Family Welfare has prepared a draft for guidelines for home quarantine, as well as for the use of masks by public, in view of coronavirus.

What to do in Home Quarantine?

The government says, for those taking refuge to home quarantine should stay in a well-ventilated single-room preferably with an attached or separate toilet. It adds that if another family member needs to stay in the same room, it's advisable to maintain a distance of at least 1 metre between the two.

The government advised, coronavirus patients to stay away from elderly people, pregnant women, children and persons with co-morbidities within the household as their immune system may be low. The health minister also suggested to restrict the patient's movement within the house. "Under no circumstances attend any social/religious gathering e.g. wedding, condolences, etc, said the guideline.

It also instructed the corona virus infected person to avoid sharing household items like dishes, drinking glasses, cups, eating utensils, towels, bedding, or other items with others at home. The guideline also demanded that even though home quarantine, the patient should wear a surgical mask at all times. "The mask should be changed every 6-8 hours and disposed off. Disposable masks are never to be reused, it added.

"Masks used by patients/ caregivers/ close contacts during home care should be disinfected using ordinary bleach solution (5 per cent) or sodium hypochlorite solution (1%) and then disposed of either by burning or deep burial," instructs the government.

Even for family members of a patient, the health ministry clearly instructs to use disposable gloves when cleaning the surfaces or handling soiled linen. No visitors, under any circumstances will be allowed, said the guideline.

"In case the person being quarantined becomes symptomatic, all his close contacts will be home quarantined (for 14 days) and followed up for an additional 14 days or till the report of such case turns out negative on lab testing," states the draft.

How to wear & dump masks?

There is a specific and elaborate do's and don'ts also released by the ministry. For those unsure in which mask to choose, it says, "Medical masks of different sizes and shapes are available in the market. The common ones are flat pleated masks of woven fabric which covers the nose and mouth and affixed behind the head with straps/ elastic fasteners. There are also conical or duck bill shaped masks with valves (or without valves) that fit in the contour of face over the nose and mouth, but are costlier."

However, the ministry warns, medical masks should not be used by healthy persons who are not having any symptoms "because it creates a false sense of security". Instead, it suggests to refrain from touching face, mouth, nose and eyes as well as washing hands regularly with soap for 20 seconds each time.

However, when a person develops a cough or fever, the suspected patient needs to switch to medical masks. "Use of medical three layer masks when ill, will prevent your infection from spreading to others. However you also need to wash your hands frequently to avoid spreading infection to others," read the guideline.

Even if one is not tested positive but showing symptoms, they are advised to wear masks while visiting a healthcare facility. "Close family contacts of such suspect/confirmed cases undergoing home care should also use Triple layer medical mask," it warns.

The ministry has also given point by point guideline on how to use a mask like to make sure that they are facing down while unfolding or for that matter to ensure there are no gaps on either side of the mask.

It even warns, "Fit flexible nose piece (a metallic strip that can easily be located) over nose-bridge" to ensure no one else are infected. The government also warns against simple dumping of the masks once used. Instead one should disinfect "using ordinary bleach solution (5 per cent) or sodium hypochlorite solution (1 per cent) and then disposed of either by burning or deep burial," says the Health Ministry.

COVID-19 emerged in early December 2019 in China's Wuhan province and has now spread to over 100 countries. As on March 9, 2020, India has reported 42 cases mostly among those who had travelled from affected countries.

However the government says, "It causes a minor illness in majority of patients with symptoms of fever and or cough. A small proportion of such persons may progress to severe disease with difficulty in breathing."

Thiruvananthapuram, Apr 2: With the coronavirus lockdown in place, liquor would be delivered home by state-run retail outlets in Kerala after the left government has decided to issue special passes to tipplers, who exhibit withdrawal symptoms and have doctors prescription.

Protesting the government decision, the Kerala Government Medical Officers Association (KGMOA) wore black badges on Wednesday, but attended duty and seeking immediate withdrawal of the order, saying it was "anti-people".

As per guidelines issued by the Kerala State Beverages Corporation managing director G Sparjan Kumar, for the supply of liquor, a service charge of Rs 100 would be collected from each pass holder for meeting the delivery expenses.

Each person would be entitled to 3 litres of Indian Made Foreign Liquor (IMFL) and sale of wine and beer was not envisaged, the order stated.

Those not willing to undertake the home delivery, the name and details of the employee should be reported to the Head office for submission to the government, it said.

A civil police officer will have to accompany the distribution vehicle.

The sale of liquor should be only to the pass holders, limiting it to the quantity mentioned in the pass.

Any excess sale to pass holders or sales to non-pass holders is strictly prohibited, the order said.

In the order issued on Monday, the government said, following the lockdown and the closure of liquor outlets in the state, there were many instances of social issues, including suicidal tendencies shown by those who consumed liquor regularly and the state government has decided to initiate steps to resolve the matter.

Speaking to reporters, chief minister Pinarayi Vijayan said his government has not forced anyone to prescribe liquor to addicts.

He was responding to a query on the indifference of doctors towards the matter of prescribing liquor to addicts.

"If the doctors are not ready to prescribe liquor, it's fine. We are not forcing anyone to do so. We were just following the protocol which are prevalent at many places. It's been over a week. The family and friends of the addicts can gently persuade them to approach the de-addiction centres," he said.

Sparjan Kumar said the order on home delivery was just a modality, as part of the earlier order issued by the government to provide liquor under prescription.

"We have worked out a modality. We have a meeting tomorrow. Some new order has been issued by the Centre today. The meeting will discuss the implementation of the orders," Kumar told.

A person showing withdrawal symptoms has to get a doctor's prescription on his condition so that he could be provided liquor in a "controlled manner", the order added.

The Indian Medical Association (IMA) has also come out against the government's move.

Meanwhile, Vimukthi, an anti-narcotics campaign launched by the state government, has till now admitted 64 patients since March 24.

"Since March 24, the day lockdown started, we have 64 patients admitted due to withdrawal symptoms. We have also registered at least 200 out patients at various de-addiction centres across Kerala," K Mohammed Resheed, Joint Excise Commissioner in charge of awareness told.