The Subject Experts Committee (SEC) of the Drug Controller General of India (DGCI) has granted "in principle" approval to Bharat Biotech for the conduct of Phase III superiority study and Phase III booster dose study trials for its intranasal COVID-19 vaccine.
Earlier, the company had proposed the booster dose for those who have been already been innoculated with Covishield and Covaxin vaccines.
Bharat Biotech aims to conduct clinical trials on 5,000 subjects (50 per cent vaccinated with Covishield and 50 per cent vaccinated with Covaxin).
The gap between the second and the intranasal booster dose.will be around six months.
(With inputs from IANS)
