Bharat Biotech International Limited (BBIL) on August 15 said its COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III.

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. 

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 the 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. Primary dose schedule phase III trials were conducted for safety, and immunogenicity in approximately 3,100 subjects, and compared with Covaxin. The trials were conducted in 14 trial sites across India.

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. The trials were conducted in 9 trial sites across India.