Destruction of documents, insufficient data lead FDA to reject hep B vaccine update

Dy­navax’s he­pati­tis B vac­cine was re­ject­ed for a la­bel ex­pan­sion in the US af­ter pa­tient da­ta was de­stroyed by a third-par­ty clin­i­cal tri­al site op­er­a­tor, the com­pa­ny an­nounced Tues­day.

The com­plete re­sponse let­ter cit­ed the de­struc­tion of “da­ta source doc­u­ments by a third-par­ty clin­i­cal tri­al site op­er­a­tor for ap­prox­i­mate­ly half of the sub­jects en­rolled in the tri­al.” It al­so said that 119 he­modial­y­sis pa­tients in the sin­gle-arm HBV-24 study was not enough to de­ter­mine safe­ty, ac­cord­ing to Dy­navax.

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