The Food and Drug Administration (FDA) has granted Fast Track designation to BLB-201, a vaccine candidate for the prevention of respiratory syncytial virus (RSV) associated disease in adults aged over 60 and children aged under 2 years.
BLB-201 is an intranasal, single dose vaccine based on an attenuated strain of parainfluenza virus 5 (PIV5) that expresses the RSV-F protein. According to the Company, preclinical studies demonstrated that the vaccine induces serum antibody and mucosal antibody responses, as well as cell-mediated immune responses. Additionally, protection from RSV infection was demonstrated in challenge studies conducted in multiple animal species.
A phase 1 trial (ClinicalTrials.gov Identifier: NCT05281263) is expected to begin soon to assess the safety and immunogenicity of BLB-201. The trial is being led by Paul Spearman, MD, Director of Infectious Diseases at Cincinnati Children’s Hospital Medical Center.
“FDA’s granting of Fast Track designation for BLB-201 reflects the urgent need for an RSV vaccine,” said Dr Biao He, founder and CEO of Blue Lake Biotechnology and its parent company, CyanVac LLC. “It is encouraging that FDA recognizes the potential of our vaccine to address this need for children under 2 years old as well as for older adults.”
A recent global study using data from 2019 found that RSV infection contributes to substantial mortality in children.
Blue Lake Biotechnology announces FDA Fast Track designation for BLB-201 intranasal RSV vaccine. News release. May 24, 2022. https://www.prnewswire.com/news-releases/blue-lake-biotechnology-announces-fda-fast-track-designation-for-blb-201-intranasal-rsv-vaccine-301553567.html