Bharat Biotech has completed the phase-1 clinical trials of its intranasal vaccine candidate, BBV154, and the data has been submitted to the Central Drugs Standard Control Organisation (CDSCO).
The data was analysed by a subject expert committee (SEC) on Tuesday. A senior official told CNN-News18 that the manufacturer sought permission from the panel for a change from nasal drop to nasal spray for their product.
The subject expert committee of CDSCO was of the opinion that Bharat Biotech should use both drop and spray for the clinical trials. The Central Drugs Standard Control Organisation, which comes under the ministry of health and family welfare, is India’s national regulatory body for pharmaceuticals and medical devices.
BBV154 is a single-dose, chimpanzee adenovirus vectored intranasal vaccine being developed by the Hyderabad-based vaccine maker in collaboration with the University of Washington School of Medicine at St Louis.
The advantage of a nasal spray vaccine, according to experts, is that it can secure an immune response at the site of infection, which in the case of the novel coronavirus is the nose, where the pathogen attacks human cells. Apart from preventing infection, a nasal spray vaccine can also help to check the transmission of the virus. Further, this method eliminates the need for syringes and needles, and neither does it require trained healthcare workers to administer it, potentially indicating lower costs for a vaccination drive that uses the nasal spray.
Bharat Biotech had earlier said the intranasal candidate has already shown superior protection against SARS-CoV-2 in animal studies.
The phase-1 trials have been conducted on 175 volunteers across the country in the age group of 18-60 years.