Bio E Vaccine Candidate Gets Ph-III Trial Approval India News
HYDERABAD: Vaccine maker Biological E Ltd has received the approval of the committee of experts in the field (SECOND) of the Central Organization for Standard Control of Medicines (CDSCO) to begin phase III clinical trials of its Covid-19 subunit vaccine candidate, Swati Bharadwaj reports. The company is developing the vaccine based in Texas. Baylor College of Medicine (BCM).
Phase III trials of the recombinant protein vaccine will be conducted in 1,268 healthy volunteers in the 18-80 age group at 15 sites in India to assess the immunogenicity and safety of the vaccine. This is part of a larger global phase III study, Biological E said on Saturday. Phase I and II trials were carried out in 360 healthy volunteers in the age group 18 to 65 years.