Covid intranasal vaccine phase III trials over, proven safe: Bharat Biotech

Data from both phase III human clinical trials have been submitted for approval to national regulatory authorities.

Covid intranasal vaccine phase III trials over, proven safe: Bharat Biotech
Being an intranasal vaccine, BBV154 could produce local antibodies in the upper respiratory tract, which may provide the potential to reduce infection and transmission.

Bharat Biotech has completed clinical development for phase III trials and booster doses for its intranasal Covid-19 vaccine (BBV154). The company on Monday said BBV154 has proven to be safe, well-tolerated and immunogenic in subjects in controlled clinical trials phase III.

Data from both phase III human clinical trials have been submitted for approval to national regulatory authorities. If approved, this would the country’s first intranasal Covid vaccine.

Two separate and simultaneous clinical trials were conducted to evaluate the vaccine 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.

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Being an intranasal vaccine, BBV154 could produce local antibodies in the upper respiratory tract, which may provide the potential to reduce infection and transmission. Further studies are being planned. The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries, a press release issued by the vaccine maker said.

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,” Ella said.

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The BBV154 is 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. BBV154 has been specifically formulated to allow intranasal delivery.

BBV154 has been developed in partnership with Washington University St Louis. Product development, manufacturing scale-up, formulation and delivery device development, including human clinical trials, were conducted by Bharat Biotech. The Centre partly funded product development and clinical trials through the Department of Biotechnology’s Covid Suraksha programme.

Trials were conducted in 14 sites across India. Primary dose schedule phase III trials were conducted for safety and immunogenicity in 3,100 subjects. Heterologous booster dose studies were conducted for safety and immunogenicity in 875 subjects, where a booster dose of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed Covid vaccines. Trials were conducted in nine trial sites across India.

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