Hyderabad-based Bharat Biotech completes phase-III trial of nasal Covid-19 vaccine BBV154

“This vaccine candidate was evaluated 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,” the company said in a statement on Monday.

Moreover, two separate and simultaneous clinical trials were conducted to evaluate the intranasal vaccine as a primary dose schedule and a heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid-19 vaccines in India.

Bharat Biotech’s Chairman and MD Krishna Ella earlier said, “Injectable vaccines only protect the lower level (of the body). That’s why people who were vaccinated with injectable vaccines might still test positive in RT-PCR, whereas the nasal jab gives protection to the whole body.”

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

According to the company, the primary-dose schedule phase-III trials were conducted for safety and immunogenicity in 3,100 subjects and compared with Covaxin. The trials were conducted in 14 sites across India.

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

BBV154 was developed in partnership with the Washington University of 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 growth, formulation, and delivery device development, including human clinical trials, were conducted by Bharat Biotech.

The Central government partially funded the product’s development and clinical trials through the Department of Biotechnology’s COVID Suraksha programme.

Bharat Biotech Joint Managing Director Suchitra K Ella said in a statement, “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.”