Bharat Biotech says Phase 3 trial over, intranasal vaccine 'safe'

Seeks nod as both primary and precaution dose

Bharat Biotech has submitted data from Phase 3 clinical trials of BBV154, its intranasal Covid vaccine candidate, to the drug regulator. It has sought approval both as a primary two-dose vaccine, and a heterologous booster shot.

A heterologous booster implies that the third or subsequent dose of the vaccine is different from its primary dose. Typically, the primary dose comprises two shots. The Hyderabad-based company claimed that BBV154, which is stable at 2-8 degrees Celsius, is proven to be safe, well-tolerated and immunogenic in the subjects under controlled clinical trials.

“Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract. These may provide the potential to reduce infection and transmission. Further studies are being planned,” the company noted on Monday.

Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose regimen), and a heterologous booster dose. These were for subjects, who had already received two doses of the two commonly-administered vaccines — Covishield and Covaxin.

“Data from Phase III human clinical trials has been submitted for approval to the National Regulatory Authorities,” the company said.

Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana. Primary dose schedule Phase III trials were conducted for safety, and immunogenicity in around 3,100 subjects and compared with Covaxin. The trials were conducted at 14 sites across India.

Heterologous booster dose studies were conducted for safety and immunogenicity in around 875 subjects. The booster dose (third dose) of BBV154 intranasal vaccine was administered to study the participants, who were previously vaccinated with licensed Covid vaccines. The trials were conducted at nine sites across India.

“BBV154 has been specifically formulated to allow intranasal delivery. The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries,” the company said.  

BBV154 was developed in partnership with Washington University, which had designed and developed the recombinant adenoviral vector constructs. It evaluated them in preclinical studies for efficacy.

Product developments 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 Centre partly funded the product development and clinical trials through the department of biotechnology’s Covid Suraksha programme. Suchitra K. Ella, joint managing director, Bharat Biotech, said, “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.”

She added, “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.”     

THE PROCESS

• Two separate and simultaneous clinical trials were conducted to evaluate the vaccine as both primary and booster dose
• Data from both Phase III human clinical trials have been submitted for approval to National Regulatory Authorities
• Trials for primary dose were conducted for safety and immunogenicity in 3100 subjects, and compared with Covaxin
• Booster dose studies, where the first two doses were of a different vaccine, were conducted in 875 subjects
• The vaccine was found producing local antibodies in the upper respiratory tract, which may reduce transmission