Bharat Biotech, the maker of Covaxin, on Friday obtained approval from the Drugs Controller General of India (DCGI) for conducting trials of its intranasal booster doses against Covid-19 (BBV154), Trend reports citing The Indian EXPRESS
According to news agency ANI, the trials will be conducted at nine different sites in India.
“The Phase-3 clinical trial should be conducted as per protocol multi-centre study to compare immunogenicity and safety of BBV154 with Covaxin,” the letter issued by the DCGI said.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
Bharat Biotech had last month sought the drug regulator’s approval to conduct phase 3 trials of the nasal vaccine. The approval comes soon after Covaxin and Serum Institute of India’s Covishield were cleared for sale in the market.