PremiumNEW DELHI: Biological E Ltd on Saturday said it has successfully completed phase I and II clinical trial of its covid-19 protein subunit vaccine candidate in India. It has also received the approval to start the Phase III clinical trial from the subject expert committee of the Indian regulator.
SEC’s recommendation for an approval for the trial is the penultimate step, and the Drugs Controller General of India V.G. Somani’s clearance the final step. Typically, the DCGI accepts the SEC’s recommendations.
Unlike the phase 3 trials of vaccines by Bharat Biotech International and Zydus Cadila, which conducted phase 3 safety and efficacy studies of the vaccine on over 25,000 participants each in India alone, Biological E’s phase 3 trial will include India as part of a global study, the company said in a statement.
In India, 1,268 healthy participants between the age of 18 and 80 years will be selected at 15 sites across India, and the study will evaluate the immunogenicity and safety, instead of efficacy and safety, of the phase 3 trial, the company said.
Information on how many participants will be part of the phase 3 trial globally, and its trial protocol was not immediately available. Usually, a phase 3 protocol that evaluates safety and immunogenicity of a vaccine, instead of safety and efficacy, is meant to be a comparative study with an already commercialised vaccine through a non-inferiority or superiority trial. However, this could not be immediately ascertained.
The company had started its phase I and II human clinical trial of its covid-19 vaccine candidate in the second week of November.
“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 Biological E managing director Mahima Datla said in a statement.
The vaccination schedule consists of two doses administered through an intramuscular injection 28 days apart.
While the vaccine’s antigen—active ingredient of the vaccine—was developed by US-based Baylor College of Medicine, the adjuvant—a substance used to boost the vaccine’s immune response—was developed by US-based firm Dynavax Technologies Corporation.
The Coalition for Epidemic Preparedness Innovations (CEPI) and India’s Biotechnology Industry Research Assistance Council (BIRAC) provided support for all the phases of the clinical trial.
In the first and second phase of the trial, the Hyderabad-based vaccine maker studied the safety and immunogenicity of the vaccine candidate in about 360 participants in the age group of 18 to 65 years.
“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 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.
