India’s first indigenous intranasal Covid-19 vaccine, developed by Covaxin-maker Bharat Biotech, was approved on Tuesday by the Controller General of India (DCGI) for “restricted use” in beneficiaries over the age of 18 years. Union health minister Mansukh Mandaviya said the step will further strengthen “our collective fight” against the pandemic.
Called iNCOVACC (BBV154), it’s a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results, the vaccine-maker said. An intranasal vaccine is sprayed into the nostrils and then inhaled as opposed to the injectable shots, which are also referred to as intramuscular vaccines.
Earlier this year, Glenmark had launched its nitric oxide nasal spray, FabiSpray, to treat adult Covid-19 patients at high risk of progression of the disease. Bharat Biotech said iNCOVACC is the world’s first intranasal vaccine to prevent Covid.
Dr Behram Pardiwala, the director of internal medicine at Wockhardt Hospital, said it’s too early to comment on how effective an intranasal vaccine would be, considering that the dominant sub-lineage of Omicron, BA.2.75, can escape it.
As per the company, clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule for subjects who have previously received two doses of other Covid vaccines. The phase III trials were conducted for safety and immunogenicity in about 3,100 subjects, at 14 trial sites across India.
“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 to ensure that we are well prepared with platform technologies for future infectious diseases,” said Dr Krishna Ella, the chairman and managing director of Bharat Biotech.
