Bharat Biotech-made iNCOVACC becomes world's first intranasal COVID vaccine to get EUA

New Delhi [India], September 6 : The Drugs Controller General of India (DCGI) rendered an emergency use authorization (EUA) to Bharat Biotech for the intranasal vaccine- iNCOVACC, said officials on Tuesday.
The intranasal vaccine for COVID-19 by Bharat Biotech is 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 chairman of Bharat Biotech called the approval a matter of pride for the organisation and said 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," it added.
The vaccine development data will be submitted to peer-reviewed journals.
"iNCOVACC was evaluated to determine its impact on safety. The reactogenic events and adverse events that were documented during the trial were highly comparable to published data from other covid-19 vaccines. Product development data will be submitted to peer-reviewed journals and will be made available in the public domain."
The 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 with operations pan India.
The Union Health Minister Dr Mansukh Mandaviya approved the vaccine for primary immunisation of those above 18 years.
"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," Mansukh Mandaviya tweeted.
According to Dr NK Arora, Chairperson Covid-19 working group, the NTAGI intranasal vaccine will be another feather in India's fight against Covid-19.
"Nasal Covid-19 vaccine approved today is first of its kind globally- it is another feather in India's fight against Covid-19. The vaccine uses a novel approach and is likely to influence the transmission of the virus. The vaccine will be available for both primary and booster doses with completion of all regulatory requirements," Dr NK Arora told.