Bharat Biotech's first intra nasal Covid vaccine approved for emergency use

Hyderabad: iNCOVACC or BBV154, the world's first intranasal vaccine for Covid-19 developed by Hyderabad-based Bharat Biotech International Limited (BBIL), was approved for restricted use in an emergency situation by the Drug Controller General of India.

The vaccine can be used by those who are 18 years and above. It can be delivered via drops in the nose. This is the first vaccine that will protect the nose and mouth regions which are affected by the Covid-19 virus.

The vaccine is expected to help reduce the transmission of the virus and also offer protection. With the Covid-19 Omicron variant being easily transmissible and there being a threat of more different variants of Covid-19 emerging, there was a demand for a nasal vaccine.

iNCOVACC is 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.

It has been specifically formulated to allow intranasal delivery through nasal drops. This vaccine is cost-effective and can be easily used in low and middle-income countries in mass vaccination camps or immunisation programmes of the government.

The vaccine has been developed in partnership with Washington University St. Louis. They have designed and developed the recombinant adenoviral vectored constructs and evaluated them 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. The government of India's department of biotechnology, Covid Suraksha programme partly funded the programme.

The clinical trials were carried out on those who had received two doses of Covid-19 vaccines. Immunogenicity, efficacy, and the long-term impact on T and B cells were documented keeping in mind the different emerging variants.

Dr. Krishna Ella, the chairman and managing director of Bharat Biotech, said, "We are proud to announce the approval of iNCOVACC, a global game changer in intra nasal vaccines technology and delivery systems. Despite the lack of demand for Covid-19 vaccines, we continued product development in intra nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases."

iNCOVACC 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.