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Bharat Biotech International Limited (BBIL) announced on Monday that iNCOVACC (BBV154), an intranasal vaccine against coronavirus disease, has received approval from the Central Drugs Standard Control Organization (CDSCO) for heterologous booster doses under Restricted Use in Emergency Situation for all adults in India.
According to a press release from Bharat Biotech, iNCOVACC is the world’s first intranasal Covid vaccine to be approved for a primary 2-dose schedule and a heterologous booster dose. iNCOVACC is stable at 2-8°C for easy storage and distribution, according to the company.
Bharat Biotech International Limited (BBIL) announced on Monday that iNCOVACC (BBV154), an intranasal vaccine against coronavirus disease, has received approval from the Central Drugs Standard Control Organization (CDSCO) for heterologous booster doses under Restricted Use in Emergency Situation for all adults in India.
According to a press release from Bharat Biotech, iNCOVACC is the world’s first intranasal Covid vaccine to be approved for a primary 2-dose schedule and a heterologous booster dose. iNCOVACC is stable at 2-8°C for easy storage and distribution, according to the company.
iNCOVACC is a pre-fusion stabilized SARS-CoV-2 spike protein recombinant replication deficient adenovirus vectored vaccine. This vaccine candidate was evaluated in clinical trials at phases I, II, and III, with positive results. iNCOVACC has been specifically designed for intranasal administration via nasal drops. According to the statement, the nasal delivery system was designed and developed to be cost-effective in low and middle-income countries.
iNCOVACC was created in collaboration with Washington University in St. Louis. Bharat Biotech conducted product development related to preclinical safety evaluation, large-scale manufacturing scale up, formulation and delivery device development, and human clinical trials. The Government of India helped fund product development and clinical trials.
In 2020, Washington University licensed vaccine technology to Bharat Biotech for further development. The impact of iNCOVACC on safety was assessed. Clinical trials were carried out to assess iNCOVACC as a primary dose schedule and as a heterologous booster dose for those who had previously received two doses of the two COVID vaccines most commonly used in India. The reactogenic and adverse events documented during the trial were 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.
Dr. Krishna Ella, chairman and 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.”
Source:IE
