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Vaccines, Blood & Biologics

Clarification Memo Regarding Post-Marketing Required Study - July 9, 2009 - Hiberix



Date:  July 9, 2009

From:  Karen M. Farizo, M.D.
            Medical Officer, Clinical Review Branch 1

Through:  Douglas Pratt, M.D.
                 Chief, Clinical Review Branch 1

Subject:  HIBERIX Required Post-Marketing Study

To: Jay Slater, M.D.
         Chair, HIBERIX BLA Review Committee
         BLA STN# 125347

The July 8, 2009 clinical review memo for the Hiberix BLA includes a recommendation for a required postmarketing clinical trial to evaluate the safety and immunogenicity of Hiberix compared to a U.S. licensed vaccine when administered to healthy infants and children at 2, 4, 6, and 15-18 months of age, concomitantly with other recommended vaccines. As outlined in the clinical review memo, this study is intended to: 1) fulfill the requirement of the Pediatric Research Equity Act (PREA) for pediatric studies for the age group 6 weeks to 14 months of age; 2) provide the pivotal clinical data to support licensure of Hiberix for primary immunization; and 3) verify and further describe the clinical benefit of booster immunization with Hiberix, as required by CBER for accelerated approval.

A detailed review of clinical studies safety data and postmarketing safety data on Hiberix that were submitted to the BLA is provided in the July 8, 2009 clinical review memo. Based on review of these data, I do not recommend any postmarketing studies under the Food and Drug Administration Amendments Act (FDAAA) of 2007, Section 901, Title IX. Although the postmarketing study described above is required under PREA and the accelerated approval regulations (21 CFR Part 601, Subpart E), this study is not required under FDAAA for any of the following purposes:

  • To assess a known serious risk related to the use of Hiberix
  • To assess signals of serious risk related to the use of Hiberix
  • To identify an unexpected serious risk when available data indicate the potential for a serious risk.


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