Global researchers have been trying for some time to earn approval for an intranasal version of a COVID-19 vaccine, and the day has finally arrived for one region of the world. Hyderabad-based Bharat Biotech’s iNCOVACC has been given the green light in India for Restricted Use in Emergency Situations for ages 18 and above by the Central Drugs Standard Control Organisation (CDSCO) for heterologous doses. The nasal delivery system in iNCOVACC was tinkered with extensively to improve cost effectiveness for use in low and middle-income countries.
“This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines,” said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech. “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.”
This vaccine had previously been granted clearance under Restricted Use in Emergency Situation for ages 18 and above for the primary two-dose schedule. To earn approval for this, phase-3 trials were launched across 14 sites in India with more than 3,000 subjects. Receiving a thumbs up on the heterologous dose version entailed a 9-site trial set-up that saw 875 subjects receive two doses of the two commonly administered vaccines.