Two shots of the intramuscular vaccine were administered 28 days apart as part of the study that evaluated the safety and immunogenicity of the vaccine candidate. (Representative image)
HYDERABAD: Vaccine maker Biological E Ltd on Saturday said it has received approval of the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to start Phase III clinical trials of its Covid-19 subunit vaccine candidate, that it is developing with the Texas-based Baylor Medical College.
The Phase III trials will be conducted on 1268 healthy volunteers in the age bracket of 18 to 80 years across 15 sites in India to evaluate the immunogenicity and safety of the vaccine against Covid-19, as part of a larger global Phase III study.
The Hyderabad-based vaccine and pharmaceutical player said the SEC nod came after it successfully completed the Phase I/II clinical of the vaccine candidate, which kicked off in the second week of November 2020.
According to the company, its novel Covid-19 vaccine was found to be safe and well tolerated and immunogenic in the Phase I/II clinical trials that were conducted on 360 healthy subjects in the age group of 18 to 65 years.
Two shots of the intramuscular vaccine were administered 28 days apart as part of the study that evaluated the safety and immunogenicity of the vaccine candidate, consisting of the Receptor Binding Domain (RBD) of the Spike Protein of SARS-CoV-2 virus, at a three-dose level, adjuvanted with CpG 1018 plus alum, it said.
BioE’s vaccine candidate includes an antigen that is developed by the Texas Children’s Hospital Centre for Vaccine Development and in-licenced from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s advanced adjuvant CpG 1018.
“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 Ltd managing director Mahima Datla.
“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 Bottazi, associate dean of the National School of Tropical Medicine at BCM & co-director of Texas Children’s Hospital Centre for Vaccine Development.
According to Dr Peter Hotez, professor & dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development, this vaccine could “soon fill urgently needed gaps and vaccine supply shortages in Africa, Latin America, and in low-income Asian countries.”
Apart from the Phase I/II trials, Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the upcoming Phase III trials of the vaccine candidate as well, it added.