Shots:

• 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)

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Ref: Janssen | Image: Janssen