Biological E to start phase 3 clinical trials of its Covid-19 vaccine soon

The phase III clinical study, to be conducted in 15 sites across India, will evaluate the immunogenicity and safety of Biological E's vaccine candidate in 1,268 healthy subjects

Hyderabad-based vaccine maker Biological E. Limited (BE) got the Indian drug regulator's nod to start phase 3 clinical trial for its Covid-19 vaccine candidate.

Central Drugs Standard Control Organization's (CDSCO) Subject Expert Committee (SEC) approved the company's application to start phase 3 trials. NITI Aayog member V K Paul had said last week that the vaccine is expected to be ready for use sometime in August.

The phase III clinical study, to be conducted in 15 sites across India, will evaluate the immunogenicity and safety of Biological E’s SARS-CoV-2 COVID-19 vaccine for protection against Ciovid-19 disease in 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 (CEPI) 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.

BE's phase I/II clinical trial evaluated the safety and immunogenicity of the vaccine candidate in about 360 healthy subjects in the age range of 18 to 65 years.

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 and well tolerated and immunogenic," the firm claimed

“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, Managing Director, Biological E. Limited.

“This vaccine could one day soon fill urgently needed gaps and vaccine supply shortages in Africa, Latin America, and in low-income Asian countries. It’s so exciting to partner with BE helping India to provide a vaccine to halt the COVID-19 pandemic globally,” said 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.