Bharat Biotech on Friday received regulatory approval from the Drugs Controller General of India (DCGI) for Phase-3 trials of the BBV154 nasal Covid-19 vaccine.
The trials will evaluate the nasal vaccine for both the primary dose schedule as well as the booster one, Bharat Biotech said. Intranasal vaccines are easier to administer in mass immuniaation campaigns and help reduce or stop transmission, the company said.
An intranasal vaccine stimulates broad immune responses at the site of infection in the nasal mucosa and blocks both infection and transmission of Covid-19. The nasal route is considered to be good for vaccination due to the organised immune systems of the nasal mucosa. An intranasal vaccine creates an immune response in the nose, which is the point of entry for the Covid-19 virus.
The BBV154 is the first of its kind Covid-19 vaccine to undergo human trials in India. The vaccine was given regulatory approval for Phase-2 trials in August 2021. According to the company, the nasal vaccine candidate has shown protection in animal studies and demonstrated good efficacy in the Phase 2 trials. The Phase-3 trials will cover around 900 people.
The nasal vaccine is also non-invasive, needle-free and easy to administer as it does not require trained health care workers and is suitable for both children and adults. It would also reduce the use of medical consumables such as needles, syringes, and reduce the overall cost of vaccination.
Bharat Biotech has signed a licensing deal with the Washington University School of Medicine in St. Louis for the Covid-19 intranasal vaccine technology. Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe. Phase I trials took place at the university’s vaccine & treatment evaluation unit with Bharat Biotech conducting the Phase 2 and Phase 3 rounds in India.
Bharat Biotech has plans to make a billion doses of the intranasal vaccine at its facility in Genome Valley, Hyderabad.