Covaxin maker Bharat Biotech completes nasal vaccine trial, claims it is safe


Hyderabad-based vaccine manufacturer Bharat Biotech on Monday said it has completed the clinical development for phase 3 trials and booster doses for India’s first intranasal Covid vaccine BBV154.

The vaccine manufacturer claimed BBV154 to be safe, well-tolerated and immunogenic in subjects in controlled clinical trials.

The BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.

In a statement on Monday, Bharat Biotech said, “This 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.”

Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (two-dose) schedule; and a heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid vaccines in India, it added.

The primary dose schedule phase III trials were conducted for safety, and immunogenicity in around 3,100 subjects and compared with Covaxin, Bharat Biotech’s approved injectable vaccine. The trials were conducted at 14 sites across India.

However, the heterologous booster dose studies were conducted for safety and immunogenicity in approximately 875 subjects, where a booster dose (third dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed Covid vaccines, Bharat Biotech claimed in the statement. The trials were conducted at nine sites in India.

“On this 75th 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,” said Suchitra K. Ella, Joint Managing Director, Bharat Biotech.

She 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.

The company said data from both phase 3 human clinical trials have been submitted for approval to India’s regulatory authorities.