Communication Hurdles Remain For Sanofi’s Dengue Vaccine
CDC drafting recommendation for Sanofi’s Dengvaxia, setting parameters for required pre-vaccination screening in the absence of tests approved by the US FDA.
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Vaccine Decisions: US FDA And CDC Weigh New Vaccines For Diseases From Dengue To RSV
Pink Sheet infographic tracks US regulatory forecast for the many new vaccines facing the twin tests of FDA approval and CDC recommendation, which are both needed to effectively access the US commercial marketplace.
Dengvaxia Dengue Vaccine Finally Gets Green Light From CDC’s Advisory Committee
ACIP recommends Sanofi’s vaccine for use in persons 9 to 16 years old with a laboratory confirmation of previous dengue infection who are living in endemic areas. Recommendation comes two years after FDA licensure and following development of improved pre-vaccination screening tests.
Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets
A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate.