Food and Drug Administration
Center for Biologics Evaluation and
Research
SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
Meeting # 113: February 20 - 21, 2008
Hilton Hotel North Washington,
Committee Members FDA
Participants
Dr. John Modlin,
Dr. Seth Hetherington *, *** Dr.
Steven Rosenthal
Dr. Vicky Debold ** Dr.
Joseph Toerner
Dr. Jose Romero Dr.
Jerry Weir
Dr. Pablo Sanchez + Dr.
Hana Golding
Dr. Zhiping Ye
Dr. Florence Houn
Temporary Voting and
Non-Voting Members
Dr. Ermias
Belay + GlaxoSmithKline
Participants
Dr. Bruce Gellin Dr.
Thomas Verstraeten
Dr. Pamela McInnes
Dr. Steven Self Speakers
Dr. Robert Couch ++ Dr.
Nancy Cox
Dr. Theodore Eickhoff ++ Ms.
Angela Owens
LTC Wayne Hachey ++ Major
Thomas Gibbons
Dr. Nancy Cox ++, *** Mr.
Tony Colegate
Executive Secretary Committee
Management Specialist
Christine Walsh, R.N. Denise Royster
These summary minutes for the
February 20 - 21, 2008 Meeting of the Vaccines and Related Biological Products
Advisory Committee were approved on ____March 20, 2008___________.
I certify that I participated in the February 20 - 21, 2008
Meeting of the Vaccines and Related Biological Products Advisory Committee and
that these minutes accurately reflect what transpired.
________/s/________________
__________/s/______________
Christine Walsh, Executive
Secretary John Modlin, M.D., Acting Chair
* Industry Representative **
Consumer Representative ***
Non-Voting
+ Attended February 20 only ++ Attended February 21 only
The Acting Chair, Dr. John Modlin,
called the one hundred and thirteenth Meeting of the Vaccines and Related
Biological Products Advisory Committee to order at 8:30 a.m. ET on February 20,
2008. In Topic 1, the meeting addressed
the safety and efficacy of a rotavirus vaccine manufactured by GlaxoSmithKline Biologicals. On
February 21, 2008, Topic 2 of the meeting included discussion and
recommendations on the strain selection for the influenza virus vaccine for the
2008 – 2009 influenza season. Topic 3 of the meeting was an open discussion
on clinical development of influenza vaccines for pandemic and pre-pandemic
uses.
An Open Public Hearing was announced at each of the sessions
during both meeting days. Public comment
was offered February 21, 2008, during Topic 2, by Ms. Manon
Cox representing Protein Sciences Corporation.
Public comment was also made on Topic 3 by Ms. Fran Lessens representing
Passport Health and by Dr. Paul Mehlman.
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 at: http://www.fda.gov/ohrms/dockets/ac/cber08.html#VaccinesandRelatedBiological.
Open Session
Dr. Steven Rosenthal, FDA opened Topic 1 on February 20,
2008, on the safety and efficacy of Rotarix™ vaccine
manufactured by GlaxoSmithKline with an introduction and background to the
morning’s session. In his opening
briefing, Dr. Rosenthal included the questions that would be presented to the
committee for recommendation later that day.
Following Dr. Rosenthal, subsequent presentations were made by Dr. Clare
Kahn, Dr. Leonard Friedland, and Dr. Thomas Verstraeten, GSK.
Following GSK, Dr. Rosenthal returned and presented for the FDA.
An Open Public Hearing was
announced. No public comment was
offered.
Following the Open Public Hearing, the questions were presented
to the panel for discussion and recommendation.
Based on information presented to the committee regarding
the efficacy of Rotarix™, the
committee recommended:
Based on information presented to the committee regarding
the safety of Rotarix™, the committee recommended:
The committee discussed additional issues that should be
addressed in post-marketing studies beyond the applicant’s proposed
After committee discussion, the
meeting was adjourned for the day.
The Chair called day 2 of the meeting to order at 8:30 a.m.
ET on February 21, 2008. Dr. Jerry Weir,
FDA introduced the morning’s topic; strain selection for the influenza virus
vaccine for the 2008 – 2009 influenza season.
Dr. Weir’s presentation also included committee discussion questions for
consideration and recommendation.
Following Dr. Weir were a series of presentations that included Dr.
Joseph Bresee and Dr.
An Open Public Hearing was announced. Ms. Manon Cox
representing Protein Sciences Corporation made public comment.
After being presented an overview of options for strain
selection of the components for next season’s influenza vaccine, the committee
held discussion and made the following recommendations for the influenza virus
strains to be included in the vaccine for use during the 2008 – 2009 influenza season in the
After lunch, Dr. Hana Golding, FDA
opened the afternoon session, Clinical Development of Influenza Vaccines for
Pandemic and Pre-pandemic Uses, with an overview and summary of the FDA/NIH/WHO
December 2007 Workshop on Immune Correlates of Protein Against Influenza A
Virus in Support of Pandemic Vaccine Development. Following Dr. Golding, Dr. Nancy Cox, CDC presented a short update to the panel on H5NI global
surveillance in animal and humans.
Immediately following Dr. Cox, Dr. Joseph Toerner
made presentation which opened the meeting’s final discussion regarding
pandemic and pre-pandemic influenza vaccine development issues.
Dr. Toerner stated an influenza
vaccine with a pandemic indication is a vaccine intended for immunization of
persons who are at high risk of exposure to an influenza virus strain with
pandemic potential. Intended use would
include immunizing persons during a declared pandemic, laboratory workers
working with a particular strain with pandemic potential, or persons deployed
to areas with risk of getting that strain of influenza. An influenza vaccine with prepandemic
indication is a vaccine intended for immunization of persons against influenza
virus subtypes with pandemic potential during the inter-pandemic period as a
strategy for population-based pandemic influenza preparedness. Topics for discussion focused on immune
response evaluation for adjuvanted influenza vaccines
with a pandemic indication, how to confirm efficacy for vaccines with pandemic
and prepandemic indications, immune response criteria
for the prepandemic indication that would involving
priming and a “boost” during the pandemic, and size of the safety database,
especially for non-aluminum adjuvants.
An Open Public Hearing was announced. Public comments were made from Ms. Fran Lessens
representing Passport Health and Dr. Paul Mehlman.
The meeting was adjourned at
4:09 p.m.