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Approval from a Subject Expert Committee of CDSCO follows successful completion of Phase I/II
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The vaccines Biological E plans to produce with assistance of DFC’s financing complement existing efforts to immunise as many people as possible in a short span. Nagara Gopal
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.