Bharat Biotech’s Covaxin proves 77.8% effective in large Phase III trial

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<strong>Bharat Biotech's Covaxin is 77.8 per cent effective in giving protection against COVID-19, according to data from the final  Phase III trials carried out on 25,800 participants across India.</strong></p>
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According to sources, the data pertaining to the trials were studied and approved by the DCGI's Subject Expert Committee on Tuesday. The data will now be published in an internationally recognised, peer-reviewed journal.</p>
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"First interim analysis" of Phase III results, presented in March, had indicated Covaxin was 81 per cent effective in preventing COVID-19 in those without prior infection after the second dose. Data available and analysed at that stage also showed a 100 per cent reduction in chances of hospitalisation in case of infection.</p>
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The approval of the Phase III data will also help Bharat Biotech secure an EUL (emergency use listing) from the World Health Organization.</p>
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The company is expected to hold a 'pre-submission' meeting with WHO authorities on Wednesday, to discuss guidelines for final submission of required data and documents. Much of the required paperwork has already been submitted.</p>
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Last month Bharat Biotech said it expected to get WHO approval for Covaxin by September.</p>
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An EUL from WHO will allow the company to export Covaxin and make international travel easier for Indians vaccinated with the dose. Most foreign governments consider WHO approval for a vaccine as a must before according it recognition.</p>
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Covaxin and Pune-based Serum Institute’s Covishield have been the two main vaccines being used currently in India’s inoculation campaign with Russia’s Sputnik V getting approval as the third vaccine only very recently.</p>
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Meanwhile, India’s inoculation campaign has accelerated under PM Modi’s scheme to vaccinate everyone for free launched on Monday with a record 86.16 lakh doses being administered on the first day itself.</p>
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The government now aims to increase the number of vaccine shots being administered to 1 crore a day.</p>