HYDERABAD: Vaccine maker Biological E Ltd has received approval from the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to start phase III clinical trials of its Covid-19 subunit vaccine candidate, reports Swati Bharadwaj. The company is developing the vaccine with Texas-based Baylor College of Medicine (BCM).
The phase III trials of the recombinant protein vaccine will be conducted on 1,268 healthy volunteers in the 18 to 80 age bracket across 15 sites in India to evaluate the immunogenicity and safety of the vaccine. This is part of a larger global phase III study, Biological E said on Saturday. The phase I and II trials were conducted on 360 healthy volunteers in the 18-65 years age group