Bharat Biotech on Monday said its intranasal coronavirus vaccine (BBV154) has proven to be safe, well-tolerated and immunogenic in the Phase-3 clinical trials.
In a statement here, the Hyderabad pharma firm said that the vaccine, designated BBV154, was tested on 3,100 subjects across 14 locations in India. The booster jab of BBV154 was tested on 875 subjects who had received the two doses of Covid-19 vaccines used in India. The trials were conducted in 9 trial sites across India.
The vaccine candidate was evaluated earlier in phase I and II clinical trials with successful results.
BBV154 has been specifically formulated to allow intranasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries, a press release from the vaccine maker said.
BBV154 was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.
Product development related to pre-clinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, was conducted by Bharat Biotech, the statement added.
The Centre partially funded product development and clinical trials through the Department of Biotechnology’s, COVID Suraksha programme.
Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule and a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered Covid vaccines in India.
Suchitra K Ella, Joint Managing Director, Bharat Biotech, said, “On this Independence Day, we are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine. We stay committed and focused on innovation and product development; this is yet another achievement for the multidisciplinary teams at Bharat Biotech.” If approved, the intranasal vaccine will make it easier to deploy in mass immunisation campaigns with an easy to administer formulation and delivery device, she further said.
Heterologous booster dose studies were conducted for safety and immunogenicity in approximately 875 subjects, where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed COVID vaccines.