Food and Drug Administration
Center for Biologics Evaluation and Research
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
May 7, 2010
Hilton Hotel, Gaithersburg, MD
|Committee Members||FDA Participants|
|Dr. Jack Stapleton, Chair||Dr. Norman Baylor|
|Dr. Vicky Debold *||Dr. Jerry Weir|
|Dr. Jose Romero||Dr. Phil Krause|
|Dr. Pablo Sanchez||Dr. Keith Peden|
|Dr. Frank DeStefano||Dr. Wei Hua|
|Dr. Peter Gilbert|
|Dr. Margaret Rennels **|
|Temporary Voting and Non Voting Members||Speakers|
|Dr. Andrew Cheung||Dr. Umesh Parashar, CDC|
|Dr. John Coffin||Dr. Gorgon Allan, Belfast, Ireland|
|Dr. Bruce Gellin|
|Dr. Harry Greenberg||GSK Participants|
|Dr. Stephen Hughes||Dr. Emmanuel Hanon|
|Dr. Philip LaRussa||Dr. Gary Dubin|
|Dr. Pamela McInnes||Dr. Barbara Howe|
|Dr. Theodore Tsai***||Dr. Leonard Friedland|
|Dr. Melinda Wharton|
|Designated Federal Official||Committee Management Specialist|
|Christine Walsh, R.N.||Denise Royster|
These summary minutes for the May 7, 2010 Meeting of the Vaccines and Related Biological products Advisory Committee were approved on June 23, 2010.
I certify that I participated in the May 7, 2010 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.
|Christine Walsh, R.N.||Jack Stapleton, M.D.|
|Designated Federal||Official Chair|
* Consumer Representative
** Industry Representative – Did Not Attend Meeting
*** Acting Industry Representative
The Chair, Dr. Jack Stapleton called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 8:00 a.m. ET on May 7, 2010. The committee discussed available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in infants. The committee also discussed what additional steps should be considered to address this finding. The committee also discussed and made recommendations on the use of advanced analytical detection methods not currently applied for the consideration of cell substrates, viral seeds, and other biological materials used in the production of viral vaccines for human use.
An Open Public Hearing was announced for each topic. Several public comments were made.
Following is a summary of the discussion. Additional information and specific details may be obtained from the transcript of the meeting. The transcript may be viewed on the 2010 Meeting Materials, Vaccines and Related Biological Products Advisory Committee page.
Proceedings were adjourned at approximately 4:20 p.m. ET on May 7, 2010.
After opening administrative remarks, Dr. Norman Baylor, FDA, introduced the mornings topic: available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, manufactured by GlaxoSmithKline and preliminary data of unexpected findings of PCV 1 and 2 DNA in RotaTeq, manufactured by Merck. Both, Rotateq and Rotarix are US licensed rotavirus vaccines indicated for the prevention of rotavirus gastroenteritis in infants. This introductory presentation was followed by an overview of the safety and effectiveness of US licensed rotavirus vaccines presented by Dr. David Martin, FDA and Dr. Umesh Parashar, CDC, respectively. The manufacturer, GSK, discussed its assessment of porcine circovirus type 1 in Rotarix which was followed by an overview of porcine circoviruses given by Dr. Gordon Allen, Queens’s University, Belfast. Dr. Phil Krause, FDA, provided the CBER assessment of porcine circovirus in US licensed rotavirus vaccines.
The VRBPAC was asked to discuss the significance of these findings of PCV DNA and virus in rotavirus vaccines and the implications of the data for continued use of these vaccines. In its deliberations, the committee considered the postmarketing safety data of Rotarix® and RotaTeq since licensure and the impact these vaccines had in reducing rotavirus disease in the US and worldwide. Data on the more recent findings of PCV1 and PCV2 DNA in RotaTeq Ò were mentioned but, because of the preliminary nature of the findings, not specifically discussed by the committee. Some advisory committee members expressed concern with the preliminary finding of PCV2 DNA in RotaTeq Ò. However, the majority of the advisory committee members expressed support for the continued use of Rotarix Ò and RotaTeq Ò and stated that the vaccine’s benefits far outweigh the theoretical risks posed by PCV. During discussion of the application of new and more sensitive techniques for detection of adventitious agents committee members expressed the opinion that these methods should be used to evaluate products and that they may detect currently undetected adventitious agents. However, the committee advised FDA that any findings should be evaluated in a rationale manner and placed in the context of the available data from clinical studies and post-marketing use.
The meeting adjourned at 4:20 p.m.