NEW DELHI, Apr 24: The Central Drugs Standard Control Organization (CDSCO) – Subject Expert Committee (SEC) has given approval to the Biological E. Limited (BE) to start the Phase III clinical trials of its subunit vaccine candidate in India, the company claimed on Saturday.
It said the Biological E has successfully completed Phase I/II clinical trials of its Covid-19 subunit vaccine candidate in India after which it received the approval for the Phase III trial.
BE started the Phase I/II clinical trials of its Covid-19 Vaccine candidate in the second week of November 2020, the vaccine maker said. Its candidate includes an antigen developed by the Texas Childrens Hospital Center for Vaccine Development and in- licensed from BCM Ventures, Baylor College of Medicines integrated commercialization team, along with Dynavax Technologies Corporations 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, it said. 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 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. BEs novel Covid-19 vaccine was found to be safe and well tolerated and immunogenic, the release said.
Mahima Datla, Managing Director,BE,said “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.”
The Phase III clinical study to be conducted in 15 sites across India will evaluate the Immunogenicity and Safety of BEs SARS-CoV-2 Covid-19 vaccine for protection against Covid-19 in about 1268 healthy subjects in the age range of 18 to 80 years.
It is intended to be part of a larger global Phase III study, the release said.
(Manas Dasgupta)