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On Tuesday, Health Minister Mansukh Mandaviya tweeted that Central Drugs Standard Control Organisation (CDSCO) has approved Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine for primary immunization against COVID-19 in the 18+ age group for provincial use in emergencies. This vaccine is India’s first intranasal vaccine for COVID-19.

The Minister also tweeted that this initiative will bolster India’s collective battle against the pandemic. He tweeted that India has harnessed its science, research and development, and human resources in the war against COVID-19 under Prime Minister Narendra Modi’s leadership. With the science-driven strategy and Sabka Prayas, we will defeat COVID-19.

The product – iNCOVACC – is stable at 2-8°C for uncomplicated storage and distribution. Bharat Biotech stated that they established wide-ranging manufacturing capabilities at multiple sites across India, including Telangana, Gujarat, Maharashtra, and Karnataka, with operations pan-India.

Chairman and Managing Director of Bharat Biotech, Dr. Krishna Ella, stated that iNCOVACC would be a global game changer in intra-nasal vaccine technology and delivery systems. Despite the absence of demand for COVID-19 vaccines, we resumed product development in intra-nasal vaccines to guarantee that we are well prepared and ready with platform technologies for future infectious diseases.

The vaccine is designed and developed by professionals for efficient distribution and easy administration. The company noted that iNCOVACC had been evaluated to determine its influence on safety.

The statement added that the reactogenic and adverse events documented during the trial were highly analogous to the published data from other COVID-19 vaccines. Product development data will be submitted to peer-reviewed journals and will be soon made available in the public domain.

iNCOVACC has the dual benefit of promoting faster development of variant-specific vaccines and easy nasal delivery, enabling mass immunization to protect from arising variants of concern. It promises to become an essential and effective tool in mass vaccinations during pandemics and endemics. The company said that with the permit of approval today, the product will be launched and available for use soon.

The company added that iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was assessed in Phase-I, II, and III clinical trials with successful results. iNCOVACC has been particularly developed to permit intra-nasal delivery via nasal drops. The nasal delivery system is developed and designed to be cost-effective in low and middle-income countries.

iNCOVACC was developed and designed in partnership with Washington University St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical contemplations for effectiveness. Product development associated with preclinical safety evaluation, delivery device development, formulation, and large-scale manufacturing scale-up, including human clinical trials, were conducted by Bharat Biotech. The government of India funded product development and clinical trials through the Department of Biotechnology COVID Suraksha Program.

Additionally, clinical trials were conducted to evaluate iNCOVACC as a preliminary dose schedule and as a heterologous booster dose for subjects who have earlier received two doses of the two commonly administered COVID vaccines in India.

New Source: The Hindu