Bharat Biotech International Ltd BBIL said on Monday it has completed phase III and booster dose trials for its intranasal Covid- 19 vaccine BBV 154, and it has proven to be safe.
The company said that it had conducted two separate trials for its intranasal Covid vaccine, one as a primary dose schedule and another as a booster dose for subjects who have been double vaccinated with the two commonly administered Covid vaccines in India.
BBIL said in a statement that it has proven to be safe, well-tolerated and immunogenic in subjects in controlled trials.
The data from Phase III human clinical trials has been submitted to national regulatory authorities, the company said.
If approved, this intranasal vaccine will make it easier to deploy in mass immunisation campaigns with an easy to administer formulation and delivery device. A joint managing director of Bharat Biotech, Suchhitra K Ella said that vectored vaccines enable faster development of targeted vaccines in response to emerging variants of concern.
The company said its 'BBV 154' has been specifically formulated to allow intranasal delivery and designed and developed to be cost-effective in low and middle-income countries.
It is stable at 2 - 8 C, enabling easy storage and distribution, Bharat Biotech said it has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana.
BBIL said the primary dose schedule phase III trials were conducted in 14 trial sites across India for safety and immunogenicity in around 3,100 subjects, and compared to COVAXIN, the company's existing COVID 19 vaccine.
The trials for booster dose studies were conducted in nine places across India with about 875 subjects, where a booster dose 3 rd dose of BBV 154 intranasal vaccine was administered to participants.
The intranasal Covid vaccine was developed in partnership with Washington University St Louis, which developed the recombinant adenoviral vectored constructs and evaluated it in preclinical studies for efficacy, the company said.
On the other hand, BBIL took over responsibility for product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials.
The government of India has partly funded product development and clinical trials through the Department of Biotechnology's COVID Suraksha programme.