According to Bharat Biotech, Indian regulators have cleared its iNCOVACC (BBV154) intranasal vaccine against COVID-19 for use in adults aged 18 and older under a Restricted Use in Emergency Situation. Following the approval, Bharat Bio said, “the product will be launched and available for use in due course of time.”
Bharat Bio announced in September 2020 that it had partnered with Washington University in St. Louis for development of the intranasal vaccine and had acquired the distribution rights outside of the US, Europe, and Japan. The company recently announced positive results from a Phase 3 study of the vaccine that enrolled approximately 3,100 subjects.
According to Bharat Bio, the recombinant replication deficient adenovirus vectored vaccine is delivered via nasal drops, a method that was “designed and developed to be cost effective in low- and middle-income countries.” The company says that it has established that iNCOVACC is stable at 2-8 °C, making it relatively easy to store and distribute.
Bharat Biotech Chairman & Managing Director Krishna Ella commented, “We are proud to announce the approval of iNCOVACC, a global game changer in intranasal vaccines technology and delivery systems. Despite the lack of demand for COVID-19 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, the CDSCO, Dept of Biotechnology Govt of India, and Washington University St. Louis for their support and guidance. iNCOVACC has been designed for efficient distribution and easy administration.”
Read the Bharat Biotech press release.
