Bharat Biotech-made iNCOVACC becomes world’s first intranasal COVID vaccine to get Emergency Use Authorization

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The Drugs Controller General of India (DCGI) gave emergency use authorization (EUA) to Bharat Biotech for the intranasal vaccine- iNCOVACC, said officials on Tuesday, Sept. 6, 2022.
The intranasal iNCOVACC, is the first-of-its-kind needle-free vaccine.

“Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that intranasal COVID vaccine (BBV154), has received approval under Restricted Use in Emergency Situation for ages 18 and above,” read a statement from Bharat Biotech.

The iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results.

This vaccine 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 company said.

The chairman of Bharat Biotech called the approval a matter of pride for the organization adding that the intra-nasal vaccine would be a global game changer.

“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. We thank the Ministry of Health, the CDSCO, the Department of Biotechnology Govt of India, and Washington University St. Louis for their support and guidance,” said Dr Krishna Ella, chairman and managing director, Bharat Biotech.
The intranasal vaccine is a heterologous booster dose.

“Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India,” the statement added.

“Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG’s through ELISA’s. To evaluate vaccines taken through the intranasal route, IgA’s were evaluated by ELISA in serum and saliva. An evaluation was also carried out for the ability iNCOVACC to elicit long-term memory T and B cell responses against the ancestral and omicron variants,” the company said.

The vaccine development data will be submitted to peer-reviewed journals.

According to the makers, “The reactogenic events and adverse events that were documented during the trial were highly comparable to published data from other covid-19 vaccines,” and the company said product development data will be submitted to peer-reviewed journals and will be made available in the public domain.

The intra-nasal vaccine is stable at 2-8°C for easy storage and distribution, said Bharat Biotech which has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana with operations pan India.

“Big Boost to India’s Fight Against COVID-19! Bharat Biotech’s ChAd36-SARS-CoV-S covid-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO for primary immunization against COVID-19 in 18-plus age group for restricted use in an emergency situation,” Union Health Minister Mansukh Mandaviya tweeted.