By Express News Service
HYDERABAD: City-based Bharat Biotech on Monday announced it had completed clinical development for phase III trials and booster doses for BBV154 intranasal Covid vaccine.
The adenoviral intranasal vaccine BBV154 is the first of its kind Covid-19 vaccine to undergo human trials in India. “BBV154 has proven to be safe, well-tolerated and immunogenic in subjects in controlled clinical trials,” the pharma company said in a statement.
Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-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 trials for the primary dose were conducted among 3100 subjects in 14 trial sites across India, while the heterologous booster dose was done at nine trial sites among 875 subjects.
Data from both phase III human clinical trials have been submitted for approval to National Regulatory Authorities, the company 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. Further studies are being planned, it added.
ALSO READ | DCGI allows Bharat Biotech to conduct phase-III trials for COVID’s intranasal booster dose
Bharat Biotech said BBV154 has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunisation protect from emerging concern variants. It promises to become an essential tool in mass vaccinations during pandemics and endemics, it added.
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 the BBV154 intranasal vaccine. 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 concern variants.”
BBV154 is stable at 2-8°C for easy storage and distribution.
The company said they had established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.
HYDERABAD: City-based Bharat Biotech on Monday announced it had completed clinical development for phase III trials and booster doses for BBV154 intranasal Covid vaccine.
The adenoviral intranasal vaccine BBV154 is the first of its kind Covid-19 vaccine to undergo human trials in India. “BBV154 has proven to be safe, well-tolerated and immunogenic in subjects in controlled clinical trials,” the pharma company said in a statement.
Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-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 trials for the primary dose were conducted among 3100 subjects in 14 trial sites across India, while the heterologous booster dose was done at nine trial sites among 875 subjects.
Data from both phase III human clinical trials have been submitted for approval to National Regulatory Authorities, the company 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. Further studies are being planned, it added.
ALSO READ | DCGI allows Bharat Biotech to conduct phase-III trials for COVID’s intranasal booster dose
Bharat Biotech said BBV154 has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunisation protect from emerging concern variants. It promises to become an essential tool in mass vaccinations during pandemics and endemics, it added.
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 the BBV154 intranasal vaccine. 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 concern variants.”
BBV154 is stable at 2-8°C for easy storage and distribution.
The company said they had established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.
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