Janssen’s Investigational Prophylactic Vaccine Receives the US FDA’s Breakthrough Therapy Designation to Prevent Respiratory Syncytial Virus

 Janssen’s Investigational Prophylactic Vaccine Receives the US FDA’s Breakthrough Therapy Designation to Prevent Respiratory Syncytial Virus

Janssen’s Investigational Prophylactic Vaccine Receives the US FDA’s Breakthrough Therapy Designation to Prevent Respiratory Syncytial Virus

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)

Click here to read full press release/ article | Ref: Janssen | Image: Signbox

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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