The Drug Controller General of India (DCGI) has approved the Hyderabad-based pharmaceutical company Biological E to conduct phase 3 clinical trials of its COVID-19 vaccine Corbevax as a booster dose. Biological E is the second company after Bharat Biotech to conduct clinical trials for a booster dose. Based on approvals, Biological E is also generating the data systematically to study for a booster dose.
‘Biological E plans to complete production at a rate of 75 million doses of its Covid-19 vaccine Corbevax per month.’
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 percent of subjects with high risk or comorbidity conditions.
- The second is that the safety follow-up should be extended to nine months.
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. The vaccine maker company plans to deliver more than 1 billion additional doses globally.
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