The US FDA issued a Complete Response Letter (CRL) for the four-dose Heplisav-B vaccine’s sBLA. It does not affect vaccine approval across the US, EU & Great Britain plus the EC’s decision for adults on hemodialysis
The sBLA was based on immunogenicity & safety results from the P-I (HBV-24) trial assessing a four-dose regimen of Heplisav-B in adults (n=119) on hemodialysis and 5 other Heplisav-B studies in CKD adults on hemodialysis
The CRL mentioned that the results were insufficient due to the destruction of source documents by a third-party study site operator for ~50% of enrolled individuals & the total no. of individuals across the single-arm HBV-24 study was considered inadequate for its safety assessment
Ref: Dynavax | Image: Dynavax
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