Sanofi’s Dengvaxia: US FDA Panel Finds Pediatric Use More Acceptable Than Broader Target Population
Even a more limited label for the dengue vaccine may not be enough to overcome the lack of a readily available and reliable point-of-care diagnostic for screening potential vaccine recipients for previous dengue infection.
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Dengvaxia’s Restrictive Indication Will Make Immunization Recommendations Difficult, ACIP Members Say
The need to screen individuals in dengue-endemic areas for prior infection before administering Sanofi’s vaccine will be difficult to operationalize, particularly in the absence of a reliable and rapid diagnostic, experts say; Advisory Committee on Immunization Practices working group aims for full committee vote on use recommendations in February 2020.
Keeping Track: US FDA Approves Sanofi’s Dengvaxia, But Heron’s HTX-011 And Nabriva’s Contepo Fall Short
The latest drug development news and highlights from our US FDA Performance Tracker.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.