Bharat Bio's nasal Covid vax gets DCGI nod

Hyderabad: Bharat Biotech International Ltd (BBIL), a global vaccine developer for infectious diseases, on Tuesday announced that its intranasal Covid vaccine – iNCOVACC (BBV154), has received approval from Drugs Controller General of India (DCGI) under restricted use in emergency situation for ages 18 and above.

"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_India_INF for primary immunization against Covid-19 in 18+ age group for restricted use in emergency situation," Union Health Minister Mansukh Mandaviya tweeted.

He said this step will further strengthen 'our collective fight' against the pandemic. India has harnessed its science, research and development (R&D), and human resources in the fight against Covid-19 under Prime Minister Narendra Modi's leadership, he said.

"With the science-driven approach & Sabka Prayas, we will defeat Covid-19," Mandaviya also said.

According to the company, the nasal vaccine 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. The nasal delivery system has been designed and developed to be cost effective in low-and-middle-income countries.

The intranasal vaccine was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy. Product development and clinical trials were funded in part by the Government of India through the Department of Biotechnology's, Covid Suraksha programme.

Dr Krishna Ella, CMD, Bharat Biotech, said: "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."

The nasal vaccine 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 new 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. It promises to become an important tool in mass vaccinations during pandemics and endemics. With the receipt of approval today, the product will be launched and available for use in due course of time. 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.