Biological E bags DCGI nod for Corbevax trials as booster dose
New Delhi: 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.
After detailed deliberation, the Subject Expert Committee recommended granting permission to conduct proposed Phase 3 clinical trials, sources told ANI.
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.
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.
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.
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.
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.
