Big Blow To Serum Institute As Govt Panel Denies To Conduct Trials Of Covovax On Children Aged 2-17 Yrs

<p><strong>Covid Vaccination Update:</strong> India's largest Covid vaccine manufacturer Serum Institute Of India has recieved a big blow on Wenesday. An expert panel of the country's central drug authority on Wednesday recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trial of COVID-19 vaccine Covovax on children aged two to 17 years.</p> <p>The SII had applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.</p> <p><a title="Also Read|Clear Covaxin, Covishield Or We Won't Accept Your Vaccine Certificates: India To EU" href="https://ift.tt/3yntm03" target="">Also Read|Clear Covaxin, Covishield Or We Won't Accept Your Vaccine Certificates: India To EU</a></p> <p>"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country," a source said, as quoted by PTI.<br />The recommendations are learnt to have been approved by the DCGI.</p> <p>The SII has been asked to submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults before proceeding with the trials on children, PTI reported.</p> <p>Novavax had announced last month that NVX-CoV2373 demonstrated 100% protection against moderate and severe disease, and 90.4% overall efficacy, in its Phase 3 trial.</p> <p>If approved Covovax would become the third vaccine to begin trials on children in India after Bharat Biotech&rsquo;s Covaxin and Zydus Cadilla&rsquo;s ZyCov-D.</p> <p>Meanwhile, Zydus Cadila applies for Emergency Use Authorisation (EUA) seeking approval from the Drugs Controller General of India (DCGI) for the launch of their DNA vaccine for 12 years &amp; above. The vaccine has completed the third phase of trial.</p> <p>(with agency inputs)</p>

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