Bharat Biotech has applied for market authorisation from the Drugs Controller General of India (DCGI) for an intranasal heterologous booster. According to reports, the five arms heterologous Intranasal booster dose means: Arm 1: 2 covaxin – booster covaxin, Arm2:2 covaxin – booster I/N vaccine, Arm 3: 2 Covishield- booster Covishield, Arm 4: 2 Covishield, Arm 4: 2 Covishield- booster I/N vaccine, Arm 5: 2 intranasal- booster intranasal.
Reportedly, the company also sought DCGI nod for phase three study of Intranasal vaccine in the 5-18 age group.
Recently, the Drugs Controller General of India(DCGI) on Tuesday has given emergency use authorisation (EUA) to Bharat Biotech for the intranasal vaccine.
“Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and vaccine developer of vaccines for infectious diseases, today announced that iNCOVACC (BBV154), has received approval under Restricted Use in Emergency Situation for ages 18 years and above,” said Bharat Biotech in a statement.
According to the vaccine maker, 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 company stated as quoted by news agencies.
According to the company, the intranasal vaccine is a heterologous booster dose. Moreover, the vaccine development data will be submitted to peer-reviewed journals.
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 company stated.
“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. We thank the Ministry of Health, the CDSCO, the 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,” said Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech.
The company claims that iNCOVACC is stable at 2-8°C for easy storage and distribution.
(With inputs from agencies)