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The Drug Controller General of India (DCGI) has given approval to the Hyderbad-based pharmaceutical company Biological E to conduct phase 3 clinical trials of its COVID-19 vaccine Corbevax as a booster dose, said sources.</p>
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&nbsp;After detailed deliberation, the Subject Expert Committee recommended granting permission to conduct proposed Phase 3 clinical trials, sources told ANI.</p>
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Biological E is the second company after Bharat Biotech to conduct clinical trials for a booster dose. On the basis of approvals, Biological E is also generating the data in a systematic manner to study for booster dose, sources said.</p>
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The Subject Expert Committee (SEC) recommended granting of permission to conduct proposed phase 3 clinical trials for boosters of biological vaccine subject to the two conditions: The first is that the administration of booster dose after primary immunization should be studied in two cohorts of six and nine months with age-wise stratification and including 50 per cent subjects with high risk or comorbidity condition. The second being that the safety follow-up should be extended to nine months.</p>
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On December 10, SEC in its meeting reviewed the data provided by Biological E. The firm had presented its revised clinical trial protocol for the conduct of phase 3 clinical trial for the administration of booster dose of COVID-19 vaccine containing receptor-binding domain (RBD) antigen of SARS-CoV-2.</p>
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The firm had submitted six months&#39; safety follow up post second dose from phase 1 clinical trials, 90 days safety data from phase 2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study.</p>
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Corbevax is India&#39;s first indigenously developed protein subunit vaccine against COVID-19 that got DCGI&#39;s approval for emergency-use authorization on Tuesday. The vaccine maker company plans to deliver more than 1 billion additional doses globally.</p>
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