Approval from a Subject Expert Committee of CDSCO follows successful completion of Phase I/II
Pharmaceuticals and biologics firm Biological E has received approval to start Phase III clinical trial of its COVID-19 subunit vaccine candidate from a Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO).
The Phase III clinical study to be conducted in 15 sites across the country will evaluate the immunogenicity and safety of Biological E’s SARS-CoV-2 vaccine for protection against COVID-19 in about 1,268 healthy subjects aged 18-80 years. It is intended to be part of a larger global Phase III study.
The SEC approval follows successful completion of the Phase I/II clinical trial that began in November second week. India has thus far given emergency use authorisation for three vaccines against COVID-19, Covishield, the indigenous Covaxin and the Russian Sputnik V. While Covishield and Covaxin are used in the immunisation programme that was launched in mid-January, imported Sputnik is expected to be available for use by June.
According to Biological E, the Phase I/II clinical trial evaluated safety and immunogenicity of the vaccine candidate in about 360 healthy subjects aged 18-65 years. The schedule consisted of two doses for each participant, administered via intramuscular injection, 28 days apart. BE’s novel Covid-19 vaccine was found to be safe, well tolerated and immunogenic, a release from the company said.
“The results of these [Phase I/II] clinical trials are very positive and promising. We believe our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials,” Managing Director Mahima Datla said.
The vaccine 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 commercialization team, along with Dynavax Technologies Corporation 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 the vaccine candidate, the release said.
Associate dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development Maria Elena Bottazzi said “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. [These] now brings added hope for a people’s vaccine to be scaled and deployed in low- and middle-income settings.”
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