Food and
Drug Administration
Center for
Biologics Evaluation and Research
SUMMARY
MINUTES
VACCINES
AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
Meeting
# 100: September 22 - 23, 2004
Committee Members FDA Participants
Dr. Gary Overturf, Chair Dr. Carl
Frasch
Dr. Ruth A. Karron Dr. Lucia Lee
Dr. David Markovitz Dr. Joseph Toerner
Cindy Lyn Province, R.N., M.S.N.*
Dr. Walter Royal III
Dr. Monica M. Farley Guest
Speakers
Dr. Philip S. LaRussa+ Dr. Luc
Kuykens, Aventis Pasteur Inc.
Dr. Peter Palese+ Dr. Greg Gilmet,
Aventis Pasteur, Inc.
Dr. Steven Self++ Dr. Michael Decker,
Aventis Pasteur, Inc.
Dr. Bonnie M. Word Dr. Gary Chikami,
Aventis Pasteur, Inc.
Dr. Richard Whitley LTC Arthur Brown,
Office of Surgeon
General, US Army
Consultants Dr. Prasert
Thongcharoen, Thai National
Dr. Peter Densen AIDS Commission
Dr. Bruce Gellin Dr. Supachai
Rerks-Ngarm, Ministry of
Dr. Pamela McInnes Public
Health, Thailand
Dr. David Stephens
Dr. Stephen Petteway**
Executive Secretary Committee
Management Specialist
Christine Walsh, R.N. Denise Royster
These summary minutes for the September 22 -
23, 2004 Meeting of the Vaccines and Related Biological Products Advisory
Committee were approved on ___________________.
I certify that I participated in the
September 22 - 23, 2004 Meeting of the Vaccines and Related Biological Products
Advisory Committee and that these minutes accurately reflect what transpired.
____________________________
____________________________
Christine Walsh, R.N. Gary D. Overturf, M.D.
Executive Secretary Chair
*Consumer Representative +Not Attending
**Acting Industry Representative ++Not attending September 23,
2004
The Vaccines and Related Biological Products
Advisory Committee (VRBPAC) met on September 22 - 23, 2004 at the Holiday Inn
Select, 8120 Wisconsin Avenue, Bethesda, MD.
In open discussion on September 22, the committee reviewed and made
recommendations on the safety and efficacy of a tetravalent meningococcal
conjugate vaccine, Menactra, manufactured by Aventis Pasteur, Inc. and on
September 23, heard an update on the phase 3 Thai Trial for the prevention of
HIV-1 infection. A closed session was
held on September 23, 2004.
Following is a summary of the open
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 at http://www.fda.gov/ohrms/dockets/ac/cber04.htm#VaccinesandRelatedBiological
Open Session
The Vaccines and Related Biological Products
Advisory Committee meeting was called to order by the Chair, Dr. Gary Overturf,
on September 22, 2004 at 10:00 a.m. EST.
Dr. Carl Frasch, FDA, presented an introduction to the License
Application for the tetravalent meningococcal conjugate vaccine, Menactra,
manufactured by Aventis Pasteur, Inc.
Dr. Frasch’s presentation included a description of the product, requested
indication, and regulatory history. The
proposed indication was for the active immunization of adolescents and adults,
11-55 years old, for prevention of invasive disease caused by Neisseria meningitidis serogroups A, C, Y and W135. The approach to licensure was based
on the demonstration of non-inferiority to Menomune, a US licensed
meningococcal polysaccharide vaccine, by immunologic and safety criteria, and
demonstration of lot consistency. Serum
bactericidal antibody was used for immunologic comparisons. Following Dr. Frasch, the product
manufacturer, Aventis Pasteur Inc. made presentations to the committee on
clinical data in support of Menactra.
Several committee members made comment and asked questions to the
manufacturing representatives pertaining to product clinical data. Dr. Lucia Lee, FDA, then made presentation
to the committee on the clinical review of safety and efficacy of
Menactra. Questions of clarification
made by committee members were directed to Dr. Lee following her presentation.
An Open Public Hearing was announced. Public comment was offered by Dr. Paul G.
King on behalf of the Coalition for Mercury Free Drugs (CoMeD) and by Mike
Kepferle from the National Meningitis Association. Dr. Carl Frasch then presented two questions and two discussion
points to the committee.
After review of the data regarding the safety
and efficacy of Menactra, manufactured by Aventis Pasteur Inc., the committee
recommended:
The committee voted
unanimously (13 votes in favor, 0 against, and 0 abstained) on the question
“Are the available data adequate to support the efficacy of Menactra, i.e.,
non-inferiority of the antibody response to Menactra compared to the licensed
polysaccharide, Menomune, when administered to individuals 11 – 55 years of
age.”
The committee voted
unanimously (13 votes in favor, 0 against, 0 abstained) on the question “Are
the available data adequate to support the safety of Menactra when administered
to individuals 11 – 55 years of age.”
The committee was also requested to comment
on two discussion points presented.
Committee members commented on the importance of collecting additional
safety data post-licensure and a need for continued evaluation of antibody
persistence. Committee members also
recommended the evaluation of safety and immunogenicity when Menactra is
administered concurrently with other licensed vaccines given to adolescents and
travelers in post-marketing studies.
The Chair adjourned Day 1 of the meeting at
3:00 p.m. EST.
The Chair called Day 2 of the meeting to
order at 9:00 a.m. EST. In open
session, Dr. Joseph Toerner, FDA, presented opening remarks to the committee on
the phase 3 Thai Trial of ALVAC vCP 1521 [Aventis Pasteur, Inc.] with AIDSVAX
B/E [VaxGen, Inc.] for the prevention of HIV-1 infection. His remarks included
a brief update about the study and an overview of some of the US FDA regulatory
challenges encountered FDA’s review. The sponsor, Office of the Surgeon
General, US Army, along with representatives from Thailand presented an
overview of the study and rationale for proceeding to Phase III. Several committee members had questions and
made comment to the sponsors.
An Open Public Hearing was announced. Public
comment was offered by Mr. Richard Jeffreys representing the Treatment Action
Group
The Chair adjourned the Open Session at 10:20
A.M. EST.
Closed Session
The Chair called the closed session to order
at 10:45 A.M. EST. After discussion,
comment, and questions, the meeting was adjourned at 12:00 noon.