Biological E (BE) on April 24 said it got approval from the India drug regulator to start phase 3 clinical trial for its COVID-19 vaccine candidate.
The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee (SEC) approved the company’s application to start phase 3 trials.
The approval to conduct Phase-3 comes at a time when India is struggling to contain second wave of the COVID-19 pandemic. Last week NITI Aayog member V K Paul had said last that the vaccine was expected to be ready for use sometime in August.
Click here to read the profile of the Hyderabad-based company.
The Phase III clinical study, which is 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 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 commercialisation team, along with Dynavax Technologies Corporation’s (Nasdaq: DVAX) 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 consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three-dose level adjuvanted with CpG 1018 plus alum, 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.
“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.
“Having our Texas Children’s and Baylor vaccine construct advance into phase III clinical studies in India and globally highlights the importance of advancing traditional protein-based vaccine platforms, which now brings added hope for a people’s vaccine to be scaled and deployed in low- and middle-income settings,” said Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development.
“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.