Bharat Biotech’s nasal vaccine gets nod for phase 2 human trials

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Bharat Biotech's nasal vaccine has received regulatory approval for Phase 2/3 trials, according to information provided by the Department of Biotechnology on Friday.</p>
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This is the first of its kind COVID-19 jab to undergo human clinical trials in India. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. BBIL has in-licensed technology from Washington University in St Louis, USA.</p>
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The vaccine is expected to play a key role stepping up the war against pandemic as it is easy to administer and would accelerate the inoculation drive.</p>
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Phase 1 Clinical trial has been completed in age groups ranging from 18 to 60 years. The company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, has been well tolerated. No serious adverse events reported. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies.</p>
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<strong>Also read:</strong>  <a href="https://www.indianarrative.com/health-news/zydus-seeks-govt-nod-for-use-of-new-india-made-vaccine-as-trials-have-been-completed-99201.html">Zydus seeks govt nod for use of new India-made vaccine as trials have been completed</a></p>
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The regulatory approval has been received for conducting“A Phase 2 randomized, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in Healthy Volunteers.”</p>
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The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have have strategized to fast-track R & D efforts vaccine development, diagnostics, drug repurposing, therapeutics and testing, the official statement said.</p>
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Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said that “the Department through Mission COVID Suraksha, is committed to development of safe and efficacious COVID-19 vaccines. Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials.”</p>