The country’s top drug regulator, DCGI, has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal COVID vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
The trials will be conducted at nine locations in the country. It will be done on 900 subjects.
The trials would evaluate the nasal vaccine for both the two-dose primary schedule and also to use as a booster dose schedule, said officials in the DCGI.
DCGI's Subject Expert Committee (SEC) gave an ‘in-principle' approval to Hyderabad-based 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.
BBV154 (nasal covid vaccine) has received approval for phase-3 clinical trials. The trials will evaluate BBV154 nasal vaccine for both the two-dose primary schedule and booster dose schedule, the sources said.
An intra-nasal vaccine would not only be simple to administer but also reduce the use of needles and syringes, among others. It would also impact the overall cost of a vaccination drive, chairman of Bharat Biotech Krishna Ella had said.
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.