- The US FDA’s breakthrough therapy designation is based on the clinical study assessing prophylactic vaccine in RSV patients aged ≥60yrs. vs SOC demonstrating substantial improvement in the clinically significant endpoints
- Following BT designation, Janssen’s vaccine is eligible for all associated FDA features and is currently being evaluated in P-IIb proof of concept study evaluating the safety and efficacy of the vaccine against RSV in adults aged ≥65yrs.
- The prophylactic RSV senior vaccine comprises the genes encoding for the fusion protein of the RSV virus as an antigen and utilizes Janssen’s adenovector platform (AdVac)
Click here to read full press release/ article | Ref: Janssen | Image: Signbox