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.
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