New Delhi: In a piece of good news for the country, the first nasal vaccine developed by Bharat Biotech and supported by Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) on Friday got approval for phase 2 and 3 trials. This was informed by the Union Ministry of Science and Technology.Also Read - Bharat Biotech Likely to Get WHO Emergency Use Approval For Covaxin on October 5
“Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials. 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,” the ministry said in a statement. Also Read - WHO's Approval For Bharat Biotech's Covaxin Likely This Week: Sources
As per the updates, Phase 1 clinical trial has been completed in age groups ranging ≥18 to ≤60 years. The company has reported that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, has been well tolerated. It also added that 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. Also Read - Previously Infected With Covid? ICMR Study Reveals Single Covaxin Shot Equivalent to 2 Doses For Unaffected
Dr RenuSwarup, 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.