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    Phase I human trials for COVAXIN begin; 10 things to know

    Phase I human trials for COVAXIN begin; 10 things to know

    Phase I human trials for COVAXIN begin; 10 things to know
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    By Pradeep Suresh   IST (Published)


    The Phase 1 clinical trial for Covaxin has been initiated across the country.

    Human trials of India's first indigenous COVID-19 vaccine, Covaxin, commenced at AIIMS Delhi on July 20,  with as many as 100 healthy people volunteering between 18 and 55 years of age. The development comes at a time when the world is desperately looking for a solution to the raging COVID-19 virus that has claimed over 6 lakh lives so far.
    Here are 10 key things you should know about the vaccine:
    1. According to Bharat Biotech, the Phase 1 clinical trial for Covaxin was initiated across the country from July 15 and this is a randomised, double-blind, placebo-controlled clinical trial of 375 volunteers across the country.
    2. The indigenous, inactivated vaccine is being developed and manufactured at Bharat Biotech's BSL-3A (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.
    3. The SARS-CoV-2 strain was isolated at NIV, Pune, and transferred to Bharat Biotech.
    4. The Drug Controller General of India, Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
    5. Several drugs have been tested for their effectiveness against COVID-19, the disease resulting from coronavirus, but they have fallen short. Gilead Sciences' remdesivir has been found to be effective in reducing the time spent in hospital by infected patients, but a cure is yet to be found.
    6. Earlier, the Indian Council of Medical Research had written to clinical trial sites to fast track all approvals and initiate enrolment for clinical trials of the indigenous COVID-19 vaccine, Covaxin, by July 7, so that "results of the clinical trials can be launched by August 15".
    7. Covaxin is an “inactivated” vaccine that was made using particles of the Covid-19 virus that were killed.
    8. As per Bharat Biotech, injecting particular doses of these particles build immunity by helping the body create antibodies against the deadly virus.
    9. The first phase of the trials for Covaxin are expected to take over a month to complete.
    10. Around 15 months are required to complete both phases of the trial.
    -With agency inputs.
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