Biological E Limited (BE), a Hyderabad vaccine and pharmaceutical company based, announced that it has completed the Phase I/II clinical trial of its Covid-19 subunit vaccine candidate in India and has obtained approval from the Central Drugs Standard Control Organization (CDSCO) – Subject Expert Committee to begin the phase III clinical trial (SEC).
The phase III clinical trial, which will be conducted at 15 locations across India, will test the immunogenicity and safety of Biological E's SARS-CoV-2 Covid-19 vaccine for protection against Covid-19 disease. The samples will be tested on 1,268 healthy people in the age group, 18 to 80. It'll be part of a broader global phase III research project.
In the second week of November 2020, BE begun the phase I/II clinical trial for its Covid-19 vaccine on volunteers. It was developed by the Texas Children's Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, as well as Dynavax Technologies Corporation's advanced adjuvant CpG 1018TM.
Each participant received two doses of vaccine, which were given 28 days apart by intramuscular injection. BE's novel Covid-19 vaccine was found to be both safe and immunogenic.
Mahima Datla, MD, Biological E Limited. said, "The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global Covid-19 vaccine as we move forward into Phase III clinical trials. "
Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development, said "This vaccine could one day soon fill urgently needed gaps and vaccine supply shortages in Africa, Latin America, and in low-income Asian countries"