FDA signs off on GSK la­bel ex­pan­sion for Tdap vac­cine

The FDA an­nounced last week that it ex­pand­ed GSK’s Tdap vac­cine, Boost­rix, for ex­pec­tant moth­ers in the third trimester of preg­nan­cy to pre­vent whoop­ing cough (per­tus­sis) in in­fants two months old and younger.

In­fants younger than two months old are too young for the per­tus­sis vac­cine al­ready in­di­cat­ed for chil­dren, mak­ing this Boost­rix la­bel ex­pan­sion the first specif­i­cal­ly al­lowed to be ad­min­is­tered dur­ing preg­nan­cy to pass pro­tec­tion to the un­born child, FDA’s Pe­ter Marks said in a state­ment.

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