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.
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. The vaccine maker company plans to deliver more than 1 billion additional doses globally.
Source: Medindia
