Bharat Biotech completes clinical development for phase III trials, booster doses for BBV154 intranasal Covid vaccine

Bharat Biotech International said on Monday that BBV154 (intranasal vaccination) has been shown in controlled clinical studies to be safe, well-tolerated, and immunogenic in individuals.

BBV154 is a pre-fusion stabilised spike protein recombinant replication-deficient adenovirus vectored vaccine. This vaccine candidate has already been studied in phase I and II clinical trials, with positive findings. BBV154 has been particularly designed for intranasal administration. Furthermore, the nasal delivery system was conceived and developed to be affordable in low and middle-income nations.

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 preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, were conducted by Bharat Biotech. The Government of India partly funded product development and clinical trials through the Department of Biotechnology’s, COVID Suraksha program.

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.

Data from both Phase III human clinical trials have been submitted for approval to National Regulatory Authorities.

Primary dose schedule phase III trials were conducted for safety, and immunogenicity in 3100 subjects, and compared with COVAXINO. The trials were conducted in 14 trial sites across India.

Heterologous booster dose studies were conducted for safety and immunogenicity in ~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.

Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract which may provide the potential to reduce infection and transmission. Further studies are being planned.

At the start of the COVID pandemic, Bharat Biotech commenced work on 4 platform technologies, the Vero cell inactivated platform, and the adenoviral vector platform have been developed.

“On this 75th Independence Day, we are proud to announce the successful completion of clinical trials for the 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, this intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy-to-administer formulation and delivery device,” said Suchitra K. Ella, Joint Managing Director, Bharat Biotech.

“Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern. We hereby thank the volunteers, principal investigators, and clinical trial personnel for all their efforts,” Ella said.

BBV154 has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunization protect from emerging concern variants. It promises to become an important tool in mass vaccinations during pandemics and endemics.

BBV154 is stable at 2-8°C, making it ideal for storage and delivery. Bharat Biotech has created major manufacturing capacities in numerous locations across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with activities throughout the country.