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April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes

Food and Drug Administration
Center for Biologics Evaluation and Review

SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

April 6-7, 2011
Hilton Hotel Washington DC North/Gaithersburg, Gaithersburg, MD

Committee Members
Dr. Jose Romero, Chair #
Dr. Vicky Debold  *
Dr. Frank DeStefano #
Dr. Peter Gilbert
Dr. Margaret Rennels **
Dr. Ambrose Cheung 
Dr. Anna Durbin
Dr. Gregory Gray       
Dr. Gary Schoolnik
Dr. Carol Tacket

FDA Participants
Dr. Norman Baylor
Dr. Wellington Sun
Dr. Jay Slater
Dr. Konstantin Chumakov +
Dr. Carolyn Wilson +
Dr. Willie Vann +
Dr. Margaret Bash
Dr. Lucia Lee +

Temporary Voting Members

Dr. Patricia Ferrieri ##
Dr. Michael Apicella  
Dr. Bruce Gellin
Dr. Pamela McInnes  
Dr. Melinda Wharton #

Speakers

Dr. Wendell Zollinger +
Dr. Amanda Cohn +
Dr. John Clements +
Dr. Leonard Mayer ++
Dr. Thomas Clark ++
Dr. Rino Rappuoli ++
Dr. John Donnelly ++
Dr. Kathrin Jansen ++

Temporary Non-Voting Member
Dr. Thomas Clark ++

Designated Federal Official
Donald Jehn, M.S.

Committee Management Specialist
Denise Royster

* Consumer Representative
** Industry Representative
+ Attended April 6 only
# Did not attend
## Acting Chair
++ Attended April 7 only

These summary minutes for the April 6-7, 2011 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on May 5, 2011.

I certify that I participated in the April 6-7, 2011 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.

/// original signed ///

__________________________

Donald Jehn, M.S.

Designated Federal Official

/// original signed ///

____________________________

Patricia Ferrieri, M.D.

Acting Chair

The Acting Chair, Dr. Patricia Ferrieri, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 9:00 a.m. EST on April 6, 2011.  During Topic 1, the Committee heard updates of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA.  Presentations were provided by CBER, OVRR, DBPAP and LBP.  

An Open Public Hearing was announced.  No public comment was offered.  The Committee then went into closed session.

In the afternoon during Topic 2, the Committee was briefed on an approach to demonstrate effectiveness of meningococcal serogroups A, C, Y, and W-135 conjugate vaccines in children younger than 2 years of age.  Presentations were provided by CBER, CDC and a meningococcal vaccines consultant. 

An Open Public Hearing was announced.  No public comment was offered.

At 8:30 am on April 7, 2011 the meeting reconvened.  The Committee reviewed and discussed approaches to demonstrate effectiveness of vaccines for prevention of meningococcal serogroup B disease during Topic 3.  Presentations were provided by CBER, CDC, Novartis and Pfizer.

An Open Public Hearing was announced.  There was one oral presentation from the public.

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 World Wide Web. Proceedings were adjourned at approximately 2:45 pm on April 7, 2011.

Open Session

After opening administrative remarks on April 6, 2011, the Committee listened to updates of CBER, OVRR, DBPAP and LBP during Topic 1. 

During Topic 2 in the afternoon, the Committee was briefed on an approach used to demonstrate effectiveness of quadrivalent meningococcal serogroups A, C, Y and W-135 conjugate vaccines in children less than 2 years of age.  After an introduction of the topic by CBER, the CDC presented the epidemiology of meningococcal disease in the U.S.  A consultant discussed use of serum bactericidal antibody as a predictor of vaccine effectiveness.  CBER then presented its overview of this topic.  The following discussion points were presented to the Committee.

  1. Please comment on the use of human serum bactericidal antibody (hSBA) as an immune measure to infer effectiveness of meningococcal conjugate vaccine for children less than 2 years old.
  2. Please discuss post-licensure studies that might be needed to further evaluate the effectiveness of meningococcal conjugate vaccines in children less than 2 years old.

The Committee was asked to discuss and comment on these points.  There were no votes. 
The Committee agreed that data derived from studies conducted in the UK supported the role of functional antibody in protection from meningococcal disease and that vaccine effectiveness can be inferred from serum bactericidal antibody measurements in children less than 2 years of age.  It was thought that post-licensure studies are needed to further evaluate the effectiveness of meningococcal serogroup A, C, Y and W-135 vaccines in children less than 2 years of age but specifics were not discussed.

Following opening administrative remarks on April 7, 2011, the Committee reviewed and discussed approaches to demonstrate effectiveness of meningococcal serogroup B vaccines during Topic 3.  After an introduction of the topic by CBER, the CDC presented epidemiological information on N. meningitidis disease and antigen diversity of candidate vaccine targets.  CBER presented an overview of the issue of evaluating effectiveness of vaccines against serogroup B meningococcal disease.  Novartis and Pfizer then presented their approaches to assessing the potential coverage and estimate effectiveness of vaccines for prevention of serogroup B meningococcal disease.  .

The Committee was asked to discuss the evaluation of effectiveness of group B meningococcal vaccines based on:

  1. Bactericidal antibodies to outer membrane protein (OMP) antigens tested in hSBA assays.
  2. Bridging test strain specific hSBA to endemic disease isolates using microbiologic characterization that predicts strain susceptibility.

The Committee was asked to discuss and comment on these points.  There were no votes.
Committee members noted that companies have generated encouraging data demonstrating that vaccine induced bactericidal antibodies reacted with a broad range of test strains in the bactericidal assay and that the approaches developed by the companies to predict killing of meningococcal type B disease strains based on antigenic markers expressed are reasonable.  The committee made  several suggestions for collecting additional data including genetic sequencing to demonstrate similarities and differences in vaccine antigens and antigens expressed by disease strains, evaluating infant sera using intrinsic complement to determine bactericidal killing of a broad range of test strains as well as systems biology approaches to predict susceptibility of disease strains to bactericidal killing.  Overall, the committee expressed a “level of comfort” in using a) bactericidal antibodies to outer membrane protein (OMP) antigens tested in hSBA assays combined with b) bridging of test strain-specific hSBA to endemic disease isolates using microbiologic characterization as an approach to demonstrate effectiveness of sub-capsular meningococcal vaccines.  Committee members expressed confidence in using serum bactericidal titer as one component to predict effectiveness, however more data need to be generated to verify microbiological characterization of disease strains to predict strain susceptibility.

Closed Session

On April 6, 2011 before the conclusion of Topic 1, there was a closed session of this meeting in order to discuss the report of the intramural research programs and make recommendations regarding personnel staffing decisions.