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Covid-19 vaccine may be considered for urgent approval after phase-3 trial if govt decides: ICMR


New Delhi, Aug 19: Top officials of the Indian Council of Medical Research (ICMR) and All India Institute of Medical Sciences (AIIMS) were present on Wednesday before the Standing Committee for Home Affairs called by Congress Deputy Leader of Rajya Sabha Anand Sharma.

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ICMR made a presentation on what really has been done so far. AIIMS too made a presentation on what the top medical college of the country has been doing to fight the deadly menace of COVID-19.

Dr Balram Bhargava was present for ICMR, while Dr Randeep Guleria was present before the committee on behalf of AIIMS. This was a marathon meeting that went on for more than four hours.

Committee chairman Anand Sharma, Bhupendra Yadav, Dr Anil Jain, Neeraj Chandrasekhar, Rakesh Sinha Ravneet Singh Bittu, Dr Satyapal Singh were some MPs present for the meeting.

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All MPs were extremely concerned about the rising number of cases in the country with over 50,000 cases being reported each day and over 1,000 deaths being reported daily.

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    The prime question asked of ICMR was what was happening on the vaccine front and when would India be able to get a vaccine.

    Sources say ICMR officials informed the panel that there was significant progress in that direction given the fact that three vaccines at various stages were under human trial. The panel was informed that at least two vaccines were in stage 2 of human trial.

    Bhargava informed the panel that three vaccines, including Bharat Biotech Cadilla Serum Institute of India, have completed two trials.

    The panel was informed that Serum Institute of India vaccine developed by Oxford University will enter phase II (b) trials from this weekend for which 1,700 patients have been identified at 17 centres across the country.

    That vaccine is likely to hit the market first among others. The final trial is likely to take anywhere between four to nine months as was informed to the committee.

    Sources in the meeting say that ICMR said post-stage 3 of human trial if the government decides to go in for urgent authorisation, it will have to be a political decision.

    ICMR also informed the panel that they would be soon reviewing the guidelines that would help people cope up better with psychological stress post-COVID-19.

    Members in particular drew attention of the authorities about the stress children face right now sitting in front of devices to attend online classes that is causing a huge amount of strain to their eyesight and also their grasping ability.

    The authorities also agreed that fighting stigma related to the pandemic remains the biggest challenge. Not just COVID-19 patients, but even their families have had a tough time in overcoming the stigma attached to it.

    Members also asked the all-important question of how many tests were being conducted each day and also how many tests were antigen or RT-PCR. The MPs also wanted to if rapid antigen was a reliable test.

    Officials informed the panel that over 8 lakh tests were conducted in the last 24 hours and they were targeting at least 10 lakh tests a day in the coming times.

    However, at this point, there was no exact breakup of the number of rapid antigen and RT-PCR tests being conducted.

    This information would duly be made available to the panel in a written response.

    Sources say ICMR informed the panel that there has been a certain level of uncertainty as far as the accuracy of test results of rapid antigen test are concerned.

    It is often seen that if a patient has tested positive on antigen, it has definitely turned out to be a positive case even through RT PCR, but in case a person tests negative in antigen, then it is best to do an RT-PCR test.

    Negative tests result of antigen have not been faulty.

    Responding to the saliva test cleared by FDA of the US, Dr Bhargava informed the panel that taking samples from gargled water is already under consideration and further details would be shared soon.

    Members also asked several questions about medicines being administered to infected patients and whether it was proving to be effective.

    The panel was informed that no medicine to cure COVID-19 has so far been there.

    The MPs also asked about regulating private hospitals which still continue charging exorbitantly for drugs, beds, etc.

    The MPs further wanted to know from the experts about plasma therapy and whether it was turning out to be a successful run. Experts did not give a definite answer and told the MPs a written reply would be given later.

    Some MPs also expressed concern on availability of testing labs in the rural areas of the country where those being tested have to wait for at least three to four days to get the results which mean they are out in the open at the risk of infecting several others.

    Committee was informed that at one stage India just had one testing laboratory and over a period of time, there are close to 1,400 labs. A proposal to start more testing labs was under consideration, especially in the rural areas.

    The committee with MPs across the political spectrum appreciated efforts of the ICMR for its stupendous role in the fight against the coronavirus. The committee also appreciated the efforts and undying spirit of the medical fraternity in its fight against the global pandemic.

    AIIMS was also praised for its effort as a mentor body helping states and hospitals across the entire country. Dr Guleria himself headed special medical teams dispatched to states that a saw surge in cases to help them prepare medically for such spikes and how to keep the mortality rates low.

    This was the second meeting of the home committee on COVID-19 and the way forward. In the earlier meeting, officials from home and health ministry had answered various questions and queries.

    Further, Sharma said the committee would put together a detailed report highlighting the concerns, learnings, findings and successes of various departments and stakeholders before Parliament.

    It is likely to present this report before both Houses in the upcoming Monsoon Session of Parliament.

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