Another vaccine from Hyd?: City firm Biological E gets nod to conduct phase III trials

Hyderabad: City-based pharmaceutical company Biological E. Limited on 24 April announced that it has received approval from the Central Drugs Standard Control Organization (CDSCO) to start phase III clinical trials of its COVID-19 vaccine candidate.

The phase III clinical study will be conducted in 15 sites across India and will evaluate the immunogenicity and safety of Biological E's SARS-CoV-2 COVID-19 vaccine for protection against COVID-19 disease in about 1,268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global phase III study.

BE started the phase I/II clinical trial of its COVID-19 vaccine candidate in the second week of November 2020. Its candidate includes an antigen developed by Texas Children's Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, along with Dynavax Technologies Corporation's advanced adjuvant CpG 1018TM. The Coalition for Epidemic Preparedness Innovations and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the phase I/II clinical trials and also for the upcoming phase III trial of this vaccine candidate, the company said.

BE's phase I/II clinical trial evaluated the safety and immunogenicity of its vaccine in about 360 healthy subjects between the ages of 18 and 65. The vaccination schedule consisted of two doses for each study participant, administered via intramuscular injection 28 days apart. BE's novel COVID-19 vaccine was found to be safe, well-tolerated, and immunogenic.

"We are delighted with the success of the phase I/II clinical trials of our COVID-19 vaccine candidate. 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," said Mahima Datla, the managing director of Biological E. Limited.

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 their vaccine could one day fill urgently needed gaps and vaccine supply shortages in Africa, Latin America, and in low-income Asian countries.