The Indian multinational biotechnology company Bharat Biotech has got nod from the Drugs Controller General of India (DGCI) for trials of its intranasal COVID booster dose in India.
The trials will be done on 900 subjects.
DCGI's Subject Expert Committee (SEC) gave an ‘in-principle' approval to Bharat Biotech for the 'phase-III booster dose study' for its intranasal Covid vaccine, a first of its kind in India, and asked it to submit protocols for approval 3 weeks ago.
Bharat Biotech is the second company to submit an application for the phase-III trial of the third dose in India. The intranasal vaccines reportedly have the potential to prevent transmission for new Covid-19 variants such as Omicron.
India has approved Covishield, Covaxin and Sputnik V for vaccination in the country. Covaxin is approved for use under the 28-day Multi-Dose Vial Policy (MDVP) from DCGI and the WHO Emergency Use Listing (WHO EUL).