Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
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
This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US
The study demonstrated that patients who received NONS had significant reduction in viral load within 24 hours, which was sustained over seven days of treatment.
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
Intranasal immunization lowers the viral load below the limit of detection in lungs of hamsters
Glenmark received manufacturing and marketing approval from DCGI for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process
Intranasal vaccines are easier to administer in mass immunisation campaigns and help reduce or stop transmission
It has also been granted permission to conduct trials for booster dose
The vaccine is designed to neutralise the virus in the nostril itself and prevent it from penetrating deep down into the respiratory tract
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