SEC allows Bharat Biotech to unblind all participants above 45 years

Recommendation based on the availability of vaccines under the immunisation programme

On March 24, the Subject Expert Committee (SEC) permitted Bharat Biotech to unblind all “participants of age group of more than 45 years and offer to administer the vaccine free of cost as and when they become eligible for the vaccine in the national programme”. The Committee recommended that the company unblind the participants as “vaccines [including Covaxin] are [already] available under the immunisation programme, and therefore all the eligible age groups under the immunisation programme should be permitted for unblinding for vaccination”. Apparently, Bharat Biotech intends to carry out a phase 3 trial in a cohort in Brazil. The company is now required to submit the “detailed revised clinical trial protocol for inclusion of a cohort from Brazil along with the revised statistical calculation for assessing the efficacy of the vaccine”.