Hyderabad-based vaccine manufacturer Bharat Biotech on Monday said it has completed the clinical development for phase 3 trials and booster doses for India's first intranasal Covid vaccine -- BBV154.
The vaccine manufacturer said that BBV154 (intra nasal vaccine) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.
The BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized 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. In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries", claimed Bharat Biotech in a statement.
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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 2 doses of the two commonly administered Covid vaccines in India, it said further.
The 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 in 14 trial sites across India.
However, the heterologous booster dose studies were conducted for safety and immunogenicity in approximately 875 subjects, where a booster dose (3d dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed Covid vaccines, Bharat Biotech claimed in the statement. The trials were conducted in 9 trial sites across India.
"On this 75th Independence Day, we are proud to announce 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," said Suchitra K. Ella, Joint Managing Director, Bharat Biotech.
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She further said that if it is 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 data from both Phase III human clinical trials have been submitted for approval to the National Regulatory authorities.
