India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19.
BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world.
It has been approved for restricted use in emergencies for people aged 18 and above in India for the first two-dose schedule and homologous booster doses.
Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinical trials of the vaccine.
Phase III trials of BBV154 were conducted to evaluate its safety and immunogenicity in approximately 3100 participants in 14 trial sites across the country.
The vaccine was also assessed in heterologous booster dose studies to study the safety and immunogenicity in nearly 875 participants.
In the studies, a booster dose of the intranasal BBV154 vaccine was given to the participants who had received licensed Covid-19 vaccines earlier.
India union minister Dr Jitendra Singh said: “India’s efforts through Mission COVID Suraksha under the leadership of Prime Minister Narendra Modi has not only strengthened AtmaNirbhar Bharat but also bolstered India’s status as a worldwide vaccine development and manufacturing centre showcasing the strength of Science and Technology.”
The BBV154 vaccine is said to have the double benefit of enabling quick variant-specific vaccine development and easy nasal delivery.
In April, Bharat Biotech received the Drugs Controller General of India’s (DCGI) emergency use approval for its Covid-19 vaccine candidate Covaxin (BBV152) to be used in children aged six to 12 years.