The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) has granted 'in principle' approval to Bharat Biotech for conduct of 'Phase III superiority study and Phase III booster dose study' trials for its intranasal COVID-19 vaccine, reported news agency ANI.
Earlier in mid-December, the company sought permission to conduct clinical trials for its intranasal booster dose.
Bharat Biotech aims to conduct clinical trials on 5,000 subjects (50 per cent vaccinated with Covishield and 50 per cent vaccinated with Covaxin).
Bharat Biotech also manufactures the COVID-19 vaccine Covaxin, which was recently given emergency use authorisation for 12-18 year olds.
(With inputs from Agencies)
