FDA ex­perts gun down a big part of Sanofi's pitch for their con­tro­ver­sial vac­cine

Sanofi has tak­en its con­tro­ver­sial dengue vac­cine to the FDA, but a pan­el of out­side ex­perts just hand­ed down a mixed de­ci­sion that could re­duce — or even elim­i­nate — any mar­ket po­ten­tial it may have in the US.

In a se­ries of votes Thurs­day af­ter­noon, the FDA’s vac­cine ad­vis­ers hand­ed down split votes on safe­ty and ef­fec­tive­ness for the phar­ma gi­ant’s tar­get pop­u­la­tion, from 9 to 45. They lost the ef­fi­ca­cy vote 6 to 7, with one ab­sten­tion, with a straight 7-7 split on safe­ty.

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