Biological E gets approval to conduct trials of Corbevax as booster dose

<p>
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>
<p>
 After detailed deliberation, the Subject Expert Committee recommended granting permission to conduct proposed Phase 3 clinical trials, sources told ANI.</p>
<p>
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>
<p>
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>
<p>
<iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/V-Ty0FPVPNM" title="YouTube video player" width="560"></iframe></p>
<p>
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>
<p>
The firm had submitted six months' 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>
<p>
Corbevax is India's first indigenously developed protein subunit vaccine against COVID-19 that got DCGI's approval for emergency-use authorization on Tuesday. The vaccine maker company plans to deliver more than 1 billion additional doses globally.</p>