HOW SOON?: A COVID-19 shot could very well happen "soon", say experts. In India, several vaccine candidates are being developed by a number of homegrown biotech firms, including the Serum Institute of Inda (SII), Bharat Biotech International Ltd., Biological E, Indian Immunologicals and Zydus Cadila. The companies are either developing their own vaccine or have partnerships with other pharmaceutical giants. The Drugs Controller General of India is the authority responsible for approving a vaccine. Indian vaccine makers already produce hundreds of millions of doses against polio, meningitis, pneumonia, rotavirus, BCG, measles, mumps and rubella, among other diseases.
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THREE VACCINES ON TRIAL IN INDIA. The subcontinent currently has three vaccines in different phases of human trials, Dr. Shriram Bhargava, director general of the Indian Council of Medical Research (ICMR), said on Tuesday. Photo shows a scientist working inside India's Serum Institute laboratory.
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NOD FOR HUMAN TRIALS: On August 3, the Drugs Controller General of India (DCGI) has given approval to Pune-based Serum Institute of India (SII) to conduct clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine in India.
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VACCINE PRICE 'AT LESS THAN WATER BOTTLE': On August 4, 2020, Dr Krishna Ella, Bharat Biotech's managing director, vowed to supply Covaxin to the whole world, at a cost "less than a water bottle." Dr. Ella worked as a research faculty at the Medical University of South Carolina, Charleston after earning his Ph.D. from the University of Wisconsin-Madison. Bharat Biotech, incorporated in 1996, has since become a global leader in vaccines. He also sits on the Scientific Advisory Committee in India's Union Cabinet.
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INACTIVATED VIRUS PLATFORM: The Clinical Trials Registry – India website states that Bharat Biotech will administer their COVID-19 shot, called Covaxin, on Day 0 and Day 14 of the trial. Bharat is using the inactivated virus vaccine platform, involving a heat-killed or dead virus that is used to generate an immune response. In the past, the company has also used this vaccine type to produce jabs for rabies, Japanese encephalitis and rotavirus.
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PHASE II CLINICAL TRIALS: On Tuesday (August 4, 2020), Dr Balram Bhargava, Director General of Indian Council of Medical Research (ICMR), claimed that vaccines from Bharat Biotech and Zydus Cadila Pharma have finished Phase-I Trials and will "soon" begin Phase II. India's Department of Biotechnology has funded Zydus Cadila's vaccine. The company had conducted pre-clinical studies on animals prior to Phase-I studies, which found an immune response in mice, rats, pigs and rabbits.
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MAJOR VACCINE PRODUCER: For many years, India has been rolling out other vaccines to different countries or via the UNICEF. The biggest challenges in vaccine development and production: prioritisation and fair distribution, logistics, stockpiling and training of people who are administering the shots.
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LAB WORK: India has reportedly prepared five sites for the final phase of human trials of the potential COVID-19 vaccine developed by Oxford. A research scientist works inside a laboratory of India's Serum Institute, the world's largest vaccine maker.
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HUMAN CLINICAL TRIAL PHASES: Phase I studies assess the safety of a drug or device. Phase II studies test the efficacy of a drug or device. Phase III studies involve a big number volunteers and is randomised, placebo-controlled and "blind" testing in several hundred to several thousand patients. Other candidate vaccines involve up to 30,000 volunteers.
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