Bharat Biotech completes indigenous intranasal Covid vaccine trial

Bharat Biotech founders Dr Krishna Ella and Suchitra Ella.

Covaxin manufacturers Bharat Biotech Bharat Biotech International Limited (BBIL), today announced that the company has completed the clinical development for Phase-III trials and booster doses for India’s first indigenous intranasal Covid vaccine.

“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,” the company said in a statement.

BBV154 (intra nasal vaccine) is a novel intranasal vaccine for Covid-19. It’s a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein.

This vaccine candidate was evaluated earlier in Phase I and II clinical trials with successful results.

According to Bharat Biotech, BBV154 has been specifically formulated to allow intranasal delivery.

“On this 75th 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,” Suchitra K. Ella, Joint Managing Director, Bharat Biotech, 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. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern. We hereby thank the volunteers, principle investigators, and clinical trial personnel for all their efforts,” she said.

The company said that BBV154 has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.

Bharat Biotech said that the data from both Phase-III human clinical trials have been submitted for approval to the Drug Controller General of India.

“The primary dose schedule of Phase-III trials were conducted for safety, and immunogenicity in 3,100 subjects, and compared with Covaxin. The trials were conducted in 14 trial sites across India,” the company said.

According to Bharat Biotech, the heterologous booster dose studies were conducted for safety and immunogenicity in 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.

The trials were conducted in nine 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, the company said.

The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries.