Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine has been approved by Central Drugs Standard Control Organisation (CDSCO) for primary immunization against COVID-19 in 18+ age group for restricted use in emergencies, Health Minister Mansukh Mandaviya tweeted on Tuesday. This is India’s first intranasal vaccine for COVID-19.
The Minister further tweeted that this step will strengthen India’s collective fight against the pandemic. “India has harnessed its science, research and development, and human resources in the fight against COVID-19 under PM Narendra Modi’s leadership. With the science-driven approach and Sabka Prayas, we will defeat COVID-19,’’ he said.
The product – iNCOVACC – is stable at 2-8°C for easy storage and distribution. Bharat Biotech in its statement said that it has established large manufacturing capabilities at multiple sites across India including Gujarat, Karnataka, Maharashtra and Telangana with operations pan-India.
Dr. Krishna Ella, chairman and managing director, Bharat Biotech, said: “iNCOVACC will be 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.‘’
Stating that it is designed for efficient distribution and easy administration, the company noted that iNCOVACC has been evaluated to determine its impact on safety.
“The reactogenic events and adverse events that were documented during the trial were highly comparable to the 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,’’ it said in a statement.
iNCOVACC has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunisation 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, the company said.
“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 intra-nasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries,’’ said the company.
iNCOVACC 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 related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation and delivery device development, including human clinical trials were conducted by Bharat Biotech. Product development and clinical trials were funded in part by the Government of India through the Department of Biotechnology’s COVID Suraksha program.
Further clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, and as a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered COVID vaccines in India.
