Bharat Biotech’s Intranasal Vaccine receives both Primary series and Heterologous booster approval from from the Central Drugs Standard Control Organisation (CDSCO).
This is first ever Intranasal Vaccine approved under restricted emergency use for 18+ for heterologous booster doses..
This vaccine was tested on 3100 candidates at 14 trial sites across India majorly for immunogenicity during phase 3 trials.
In heterologous boosting, a person administered a different vaccine from the one that was used for the primary dose series.
“The booster dose studies were conducted for safety and immunogenicity in ~875 subjects, with BBV154 intranasal vaccine administered post 2 doses of the two commonly administered COVID-19 vaccines. The trials were conducted at 9 trial sites across India,” official press release reads.
Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “iNCOVACC®, is an intranasal vaccine for the primary 2-dose schedule, and heterologous booster dose. This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines. Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases.”
“We thank the Ministry of Health, CDSCO, Dept of Biotechnology, Govt of India, Technology Development Board, and Washington University, St. Louis, for their support and guidance. iNCOVACC® has been designed for efficient distribution, easy and pain-free administration. We have also initiated development of variant-specific vaccines for COVID for future preparedness,” says Dr. Ella.
Clinical trials were conducted to evaluate iNCOVACC® as a primary dose schedule, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID vaccines in India.
“We are excited by the expansion of the EUA for iNCOVACC® as a booster, which enables this intranasal vaccine to be used by many more people, and hopefully curtail transmission,” said Michael S. Diamond, MD, PhD, of Washington University in St. Louis, who co-developed the nasal vaccine technology with Washington University colleague David Curiel, MD, PhD. “This approval will increase the options for people to get vaccinated and protected against the SARS-CoV-2 virus during the ongoing pandemic.”
Dr. Rajesh S. Gokhale, Secretary, DBT, and Chairperson, BIRAC, lauded the efforts of the scientific community and said, “DBT is fostering biotech enterprises & innovation ecosystem and strategically strengthening Indian bioeconomy. DBT, along with BIRAC, is dedicated to the development of effective and safe COVID-19 vaccines under Mission COVID Suraksha.”
iNCOVACC® is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC® has been specifically formulated to allow intranasal delivery through nasal drops.