<p>Bharat Biotech, the manufacturer of Covaxin, has submitted its phase-3 clinical trial to the Central Drug Standards Control Organisation, claiming nearly 78% efficacy of its Covid-19 vaccine, which is currently being used for mass vaccination in India.</p>.<p>An expert panel under the CDSCO on Tuesday reviewed the data, news agencies claimed quoting unnamed sources, but there was no confirmation from the Union Health Ministry on whether the home-grown vaccine received the final approval from the Drugs Controller General of India.</p>.<p>The Hyderabad-based firm claimed that the indigenous vaccine demonstrated 77.8% efficacy in the final trial conducted on 25,800 subjects. “The Covid-19 Subject Expert Committee of the CDSCO on Tuesday reviewed the data and accepted it. Their recommendations have been sent to the DCGI now,” PTI reported, quoting a source. <br /><br /><strong>Read more: <a href="https://www.deccanherald.com/science-and-environment/astrazeneca-covid-19-vaccine-linked-to-rare-neurological-disorder-in-india-uk-1000350.html" target="_blank">AstraZeneca Covid-19 vaccine linked to rare neurological disorder in India, UK</a></strong></p>.<p>Releasing the interim results from phase-3 trials in April, Bharat Biotech and ICMR claimed that Covaxin demonstrated an overall interim clinical efficacy of 78% and 100% efficacy against severe Covid-19 disease.</p>.<p>The absence of the phase-3 clinical trial data is Covaxin’s biggest stumbling block for getting the World Health Organisation certification. In the absence of the WHO recognition, those travelling abroad are now advised to take the Covishield jab to get a Covid-19 vaccination certificate.</p>.<p>Bharat Biotech is expected to attend a "pre-submission" meeting on July 23 with the WHO as a part of the process to get the Emergency Use Listing for the made-in-India shot. Though the meeting will not be a detailed review of the product, the vaccine-maker will have an opportunity to submit a summary on the overall quality of the jab.</p>
<p>Bharat Biotech, the manufacturer of Covaxin, has submitted its phase-3 clinical trial to the Central Drug Standards Control Organisation, claiming nearly 78% efficacy of its Covid-19 vaccine, which is currently being used for mass vaccination in India.</p>.<p>An expert panel under the CDSCO on Tuesday reviewed the data, news agencies claimed quoting unnamed sources, but there was no confirmation from the Union Health Ministry on whether the home-grown vaccine received the final approval from the Drugs Controller General of India.</p>.<p>The Hyderabad-based firm claimed that the indigenous vaccine demonstrated 77.8% efficacy in the final trial conducted on 25,800 subjects. “The Covid-19 Subject Expert Committee of the CDSCO on Tuesday reviewed the data and accepted it. Their recommendations have been sent to the DCGI now,” PTI reported, quoting a source. <br /><br /><strong>Read more: <a href="https://www.deccanherald.com/science-and-environment/astrazeneca-covid-19-vaccine-linked-to-rare-neurological-disorder-in-india-uk-1000350.html" target="_blank">AstraZeneca Covid-19 vaccine linked to rare neurological disorder in India, UK</a></strong></p>.<p>Releasing the interim results from phase-3 trials in April, Bharat Biotech and ICMR claimed that Covaxin demonstrated an overall interim clinical efficacy of 78% and 100% efficacy against severe Covid-19 disease.</p>.<p>The absence of the phase-3 clinical trial data is Covaxin’s biggest stumbling block for getting the World Health Organisation certification. In the absence of the WHO recognition, those travelling abroad are now advised to take the Covishield jab to get a Covid-19 vaccination certificate.</p>.<p>Bharat Biotech is expected to attend a "pre-submission" meeting on July 23 with the WHO as a part of the process to get the Emergency Use Listing for the made-in-India shot. Though the meeting will not be a detailed review of the product, the vaccine-maker will have an opportunity to submit a summary on the overall quality of the jab.</p>
