Biological E. Limited (BE) announced on Saturday that it has effectively completed Phase I/II clinical trials of its COVID-19 subunit vaccine candidate in India and obtained approval to commence the Phase III clinical trial from the Central Organization for Standard Control of Medicines. (CDSCO) – The Subject Matter Expert Committee (SEC). BE began phase I/II clinical trials of its COVID-19 vaccine candidate in the second week of November 2020, the vaccine manufacturer said in a press release.
His candidate includes an antigen developed through Texas Childrens Hospital’s Center for Vaccine Development and licensed by BCM Ventures, Baylor College of Medicines’ Integrated Commercialization Team, as well as Dynavax Technologies Corporations’ CpG 1018TM adjuvant complex. The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided assistance for phase I/II clinical trials, as well as the upcoming phase III trial of this vaccine candidate, he said.
The BE phase I/II clinical trial evaluated the protection and immunogenicity of the vaccine candidate, consisting of three doses of the SARS-CoV-2 spike protein receptor-binding domain adjuvted with CpG 1018 plus alum, in approximately 360 healthy subjects. from 18 to 65 years old. The vaccination schedule included two doses for the examined participant, administered by intramuscular injection 28 days apart.
BE’s new Covid-19 vaccine has been shown to be safe, well-tolerated and immunogenic, he said. Mahima Datla, CEO of BE, said: “We are very pleased with the good fortune of the phase I/II clinical trials of our COVID-19 vaccine candidate. The effects of these clinical trials are very positive and promising.
We believe our vaccine candidate will become another effective global COVID-19 vaccine as we move into Phase III clinical trials. The Phase III clinical study, which will be conducted at 15 sites across India, will compare the immunogenicity and defense of BEs. COVID-19 vaccine against SARS-CoV-2 for coverage against COVID-19 in approximately 1,268 healthy subjects aged 18 to 80 years. It is intended to be part of a larger global Phase III study, he said.
In Ghansoli, Mumbai, an intermediate tunnel has been built for the Mumbai-Ahmedabad high-speed rail project, which will speed up major tunnel construction works. The 394-meter tunnel will provide direct access to cars and serve as an escape route. The high-speed exercise is expected to be operational until 2026, initially between Surat and Bilimora.