Bharat Biotech's nasal vaccine gets the nod for phase 2 trial
- EP News Service
- Aug 13, 2021
NEW DELHI: The Ministry of Science & Technology today said that a first of its kind nasal vaccine for COVID-19 developed by Bharat Biotech Ltd (BBL) has got the nod of regulator for phase 2 clinical trials.
Technically named BBV154, the vaccine is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine and BBIL has in-licensed technology from Washington University in St Louis, USA.
As per the ministry, the phase 1 clinical trial for the vaccine has been completed in age groups ranging ≥18 to ≤60 years and the BBL has reported that the doses of the vaccine administered to healthy volunteers in 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 a high level of neutralizing antibodies in animal studies," the ministry said.
The ministry said that BBL has developed the intranasal vaccine with support from the Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) which has taken the task of development of vaccines as a top priority.
Dr Renu Swarup, Secretary, DBT and Chairperson of BIRAC speaking on the subject said, "The Department through Mission COVID Suraksha, is committed to the 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."
Globally similar studies are also being conducted in Canada and Britain as well and as per information available in the public domain on the current worldwide research a COVID-19 nasal vaccine would be a single dose shot and it stimulates an immune response in just 14 days.
It can also minimise the virus load in the local area from where the virus enters the body which is the nasal cavity after which it spreads to the other parts body, including the lungs.