Vaccine-maker Bharat Biotech said it successfully completed the phase-3 clinical development trials for its intranasal Covid-19 vaccine (BBV154).
Announcing that the intranasal vaccine was “proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials,” Bharat Biotech submitted for approval the results to the Indian drug regulatory authorities.
The vaccine was developed in partnership with the Washington University in St. Louis, which designed and developed the “recombinant adenoviral vectored constructs” and evaluated them in preclinical studies for efficacy.
Two separate, simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (two-dose) schedule—and a heterologous booster dose—for those who had received both doses of any of the commonly administered Covid-19 vaccines in India.
Primary dose schedule trials were conducted for safety and immunogenicity in about 3,100 subjects, at 14 trial sites across the country, and the results were compared with Bharat Biotech’s Covaxin.
Heterologous booster dose studies were conducted in 875 subjects, in nine trial sites, where a booster dose (third dose) of BBV154 intranasal vaccine was administered to study participants previously vaccinated with licensed Covid-19 vaccines.
Both study data were submitted to the national regulatory authorities, Bharat Biotech said on Monday.
The vaccine-maker’s statement also said, “Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract which may provide the potential to reduce infection and transmission.”
The Hyderabad-based biotech firm said that further studies were being planned.
“We are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine. If approved, the vaccine will make it easier to deploy in mass immunization 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,” said Suchitra Ella, joint managing director, Bharat Biotech.
According to Bharat Biotech, the BBV154 was a “recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.”
This vaccine was also evaluated in phases 1 and 2 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,” the company said in a statement.
Product development related to the preclinical safety evaluation, large-scale manufacturing scale-up, formulation and delivery device development, including human clinical trials, were conducted by Bharat Biotech, and the Indian government partly funded the product development and clinical trials through the Department of Biotechnology’s Covid Suraksha programme.
Company representatives said that BBV154 had the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunization protect from emerging concern variants. “BBV154 is stable at 2-8°C for easy storage and distribution,” the company said.