- To be given under Restricted Use in Emergency Situation (RUE) for ages 18 and above in India for heterologous booster doses.
- iNCOVACC recently received approval under Restricted Use in Emergency Situation for ages 18 and above for heterologous booster doses.
- In heterologous boosting, a person administered a different vaccine from the one that was used for the primary dose series – Phase III trials were conducted for safety, immunogenicity in ~3100 subjects, at 14 trial sites across India
Indiglobal Bureau
In a major development in the fight against Covid-19, Bharat Biotech International Limited (BBIL) has announced that its Intranasal Vaccine iNCOVACC (BBV154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above, in India, for heterologous booster doses.
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. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.
The nasal vaccine is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.
iNCOVACC was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy. Product development related to preclinical safety evaluation, large-scale manufacturing scale up, formulation and delivery device development, including human clinical trials were conducted by Bharat Biotech. Product development and clinical trials were funded in part by the Government of India, through the Department of Biotechnology’s, COVID Suraksha Program.
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. 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.”
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.