Biological E gets nod to start Phase III trials of COVID-19 vaccine

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.