BackBharat Biotech’s nasal covid vax gets CDSCO’s nod as heterologous booster
With this development, INCOVACC becomes world’s first intranasal vaccine to receive both primary series and heterologous booster approval, the company said
PremiumPharma firm Bharat Biotech on Monday announced that its intranasal covid-19 vaccine iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organization (CDSCO) for people above 18 years of age as a heterologous booster dose under restricted emergency use in India. With this development, INCOVACC becomes world’s first intranasal vaccine to receive both primary series and heterologous booster approval, the company said.
Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech said, “iNCOVACC, is an intranasal vaccine for the primary 2-dose schedule, and heterologous booster dose. This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines. Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases. INCOVACC has been designed for efficient distribution, easy and pain-free administration. We have also initiated development of variant-specific vaccines for COVID for future preparedness."
INCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results and it was evaluated to determine its impact on safety.
The phase III trials were conducted for safety, immunogenicity in approx. 3100 subjects, at 14 trial sites across India. Heterologous booster dose studies were conducted for safety and immunogenicity in approx. 875 subjects, with BBV154 intranasal vaccine administered post 2 doses of the two commonly administered COVID-19 vaccines. The trials were conducted at 9 trial sites across India.
“Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID vaccines in India while keeping it cost effective for low- and middle-income countries," the company statement said.
The vaccine is stable at 2-8°C for easy storage and distribution. The company claims that the vaccine has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern. The company further plans declare pricing and availability of the vaccine in the coming days.
Dr. Rajesh S. Gokhale, Secretary, Department of Biotechnology (DBT) said, “The DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage."
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