First intranasal vaccine for COVID-19 approved: DCGI gives green signal to Bharat Biotech's Intranasal 'Five Arms' - Know details

Bharat Biotech Nasal Vaccine: The Drugs Controller General of India (DCGI) has given approval to Bharat Biotech's Intranasal 'Five Arms' booster dose for restricted use for Covid19, as per the sources. This is India’s first intranasal vaccine for COVID-19.

The Subject Expert Committee (SEC) members of the DCGI held a meeting on November 15 to discuss the booster dose - iNCOVACC (BBV154), reported ANI.

In September of this year, BBIL submitted an application to DCGI seeking market authorization for its 'Five Arms' intranasal heterologous booster dosage. It has now been declared that iNCOVACC (BBV154) has been given the approval for Restricted Use in Emergency Situations for individuals 18 years of age and above.

"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 intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases. We thank the Ministry of Health, the CDSCO, Dept of Biotechnology Govt of India, and Washington University St. Louis for their support and guidance. iNCOVACC has been designed for efficient distribution and easy administration," Dr Krishna Ella, the chairman and managing director of BBIL stated in a statement, as per ANI.

"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. INCOVACC 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 BBIL's statement added.

"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 issued by the company read.

"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. The 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 further said.

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 BBIL added in its statement.

{With ANI inputs}