Hyderabad-based Bharat Biotech on Monday submitted its phase 3 clinical trial application to the Drugs Controller General of India (DCGI) for its booster dose of intranasal vaccine — BBV154, which is an intranasal
replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.
According to a news agency, Bharat Biotech has submitted phase 3 clinical trial application to DCGI for its booster dose of their intranasal Covid vaccine that can be given to Covaxin and Covishield vaccinated people.
The development comes nearly a month after the biotech company completed Phase II trial of intranasal Covid vaccine.
Stating that it will be a significant step forward, Krishna Ella, Chairman and Managing Director had said, “It’s going to be a lot of new science, which even the Western world is not aware of, and that’s the reason we are keeping details confidential. The nasal vaccine can stop virus transmission.”
According to experts, the intramuscular vaccine administration through injection does produce antibodies, but there is still a risk of transmission, which can be eliminated through the intranasal method.
The regulatory approval for Phase II clinical trials of the nasal vaccine candidate was granted to the company in August 2021 after successful results of the Phase 1 trials, which was conducted on 400 healthy individuals aged between 18 and 20 years. In Phase II, about 650 volunteers participated in trials conducted in 10 centres across the country.
The vaccine maker is working on a cocktail approach of administering two doses of two different vaccines using a combination of intramuscular and nasal in an ‘innovative’ approach.