Bharat Biotech claims success in intranasal Covid vaccine trials

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Bharat Biotech International on Monday said that its BBV154 intranasal Covid vaccine has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.</p>
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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.</p>
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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. It is also easier to administer on a mass scale.</p>
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BBV154 was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.</p>
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The Government of India partly funded product development and clinical trials through the Department of Biotechnology's, COVID Suraksha program.</p>
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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.</p>
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Data from both Phase III human clinical trials have been submitted for approval to National Regulatory Authorities.</p>
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“If approved, this intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy-to-administer formulation and delivery device," said Suchitra K. Ella, Joint Managing Director, Bharat Biotech.</p>