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Vaccines, Blood & Biologics

Confirmation Memo on BIMO Inspections - March 30, 2009 - Hiberix

From:                     Drabick, Christine

Sent:                      Monday, March 30, 2009 7:09 AM

To:                         Farizo, Karen

Cc:                         Temenak, Joseph; Humbert, Jason (CBER); Slater, Jay; Holobaugh, Patricia

Subject:                 RE: Need for BIMO inspections for Hiberix?


          Thank you for confirming that we will not need BIMO inspections at this time.  BIMO inspections for the planned confirmatory study appear to be the best option.


From: Farizo, Karen
Sent: Friday, March 27, 2009 5:27 PM
To: Drabick, Christine
Cc: Temenak, Joseph; Humbert, Jason (CBER); Slater, Jay
Subject: FW: Need for BIMO inspections for Hiberix?


Please see Email from Dr. Baylor indicating that BIMO inspections are not needed for the Hiberix BLA.



Joe and Jason: Please include the Email messages below in the file. Thanks.  


From:                     Baylor, Norman 

Sent:                      Friday, March 27, 2009 5:17 PM

To:                          Farizo, Karen

Cc:                          Pratt, Douglas R.

Subject:                RE: Need for BIMO inspections for Hiberix?


Given when these studies were done, I don't think a BIMO inspection will yield much if any useful information.  Further, I am not sure what records would be available now.  My recommendation is to waive any BIMO inspections for the Hiberix booster.  -----------b(5)----------------------------------------------------------------------------------------.


From:             Farizo, Karen 

Sent:              Friday, March 27, 2009 4:57 PM

To:                  Baylor, Norman

Cc:                  Pratt, Douglas R.

Subject:        Need for BIMO inspections for Hiberix?


I would like to get your input on the need for BIMO inspection(s) for site(s) that participated in the Hiberix studies that have been submitted to the BLA. There are 7 booster immunization studies and 2 supportive primary immunization studies in the BLA. The studies were conducted in the mid-to late 1990s either in Canada, Germany, Lithuania, or South America. The number of Hiberix subjects enrolled in each of the booster studies ranges from ~40-150, with the exception of one booster study that evaluated safety only and enrolled ~370 subjects in the Hiberix group.  

The BIMO reviewer has asked for input about what, if any, sites should be inspected. However, she has cautioned that given that all study sites are outside of the U.S., an inspection would not yield any information before the target decision date of August 1, 2009. Douglas and I have also questioned whether records would necessarily be available at the sites for studies conducted 10-15 years ago.

If I had to select a study for BIMO inspection it would be the largest booster study (~370 Hiberix subjects evaluated for safety) which was conducted in Germany. Subjects in this booster study had previously participated in a primary series Pediarix study that was pivotal for the Pediarix BLA. While I don't know if there were BIMO inspections of any of the sites under the Pediarix BLA, there was likely considerable overlap in sites for this Hiberix booster study and a pivotal study that we used to support the safety of Pediarix.  

I have discussed this with Douglas and our view is that given the circumstances of the Hiberix BLA, BIMO inspection(s) would unlikely be very useful. I also recall that in our internal meeting prior to the pre-BLA meeting, you suggested that BIMO inspections would not be needed for this BLA. However, Douglas and I wanted to get your input before conveying to BIMO that no inspections are needed under the current booster BLA for Hiberix. --b(5)------------------------------------------------------------------------------------------ --.



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