Hyderabad: First Indian Intra-Nasal Vaksin Candidate – BBV154, which is being developed by Bharat Biotech along with the University of Washington in St.
Louis (Washu), has received approval from the drug regulator to conduct a phase-2 clinical trial.
Ministry of Union Minister of Science & Technology said the chimpanzee vector vaccine which lacked intransal replication Adenovirus SARS-COV-COV-2 not only became the first nose vaccine to receive regulatory approval for phase-2 trials in India, it was also the first of it kind of covid 19 Vaccines to undergo human clinical trials in India.
Bharat Biotech has received regulatory approval to conduct phase-2 clinical trials randomly, multi-centric, clinical combination of heterologous boost from the SARS-COV-2 vaccine to evaluate the immunogenicity and security of BBV152 (covaxin) with BBV154 in healthy volunteers, the ministry said.
Bharat Biotech recently completed the clinical trial phase-1 of the ChancanZee Adenovirus vaccine in healthy volunteers in the 18-60 year age group.
The ministry said the dosage given to volunteers in the phase-1 trial “was well tolerated”.
“There are no serious side effects (is) reported.
Previously, the vaccine was found safe, immunogenic and well tolerated in pre-clinical toxicity studies.
This vaccine is able to obtain high-level neutralization antibodies in research on animals,” he said.
Intrasal vaccine development has been supported by the Biotechnology Department (DBT) and the Biotechnology Industry Research Assistance (BIAC), he said.
Secretary of DBT and Chairman of BIRAC Dr.
Renu Swarup said BBV154 Bharat Biotech was the first intranasal vaccine developed in this country to enter the final clinical trial.