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Interagency Vaccine Group

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Interagency Vaccine Group

NVPO Meeting with Manufacturers on ISO Agenda Final 3/21/08

    National Vaccine Program Office (NVPO)

    Individual Simultaneous Consultation:

    Input from Vaccine Manufacturers’ Representatives

    On the ISO Research Agenda

    November 16, 2007

    Meeting Summary

    In Attendance:

Centers for Disease Control and Prevention (CDC) GlaxoSmithKline

    Karen R. Broder Harry Seifert John K. Iskander MedImmune Dixie E. Snider (CDC moderator) by telephone: Aaron Mendelsohn Nelson Arboleda Jeff Roncal James M. Baggs Gabrielle L. Fowler Merck Paul M. Gargiullo

    Fabio Lievano Tanya Johnson

    Luwy Musey Barbara Slade

     Eric S. Weintraub Novartis Food and Drug Administration (FDA) Barbara Mahon Robert Ball sanofi pasteur Carmen M. Collazo-Custodio David R. Johnson National Vaccine Advisory Committee (NVAC) Alena Khromava Andrew T. Pavia Wyeth National Vaccine Program Office (NVPO) Ann Strauss

    Laura YorkKenneth J. Bart

    Bruce Gellin

    Daniel Salmon (Chair)

Disclaimer: This document does not represent Centers for Disease Control and Prevention (CDC) or

    National Vaccine Program Office (NVPO) policy, nor does it necessarily reflect which ideas will be

    incorporated into CDC’s final Immunization Safety Office Scientific Agenda. This document has been reviewed by meeting participants.

    1 Background and Administrative Summary:

    CDC’s Immunization Safety Office (ISO) is developing a comprehensive,

    scientifically robust Research Agenda with extensive input in a transparent manner; the horizon is 3-to-5 years. ISO is working with the National Vaccine Program Office (NVPO) and National Vaccine Advisory Committee (NVAC) to respond to a recommendation from the 2005 Institute of Medicine (IOM) report: “Vaccine Safety

    Research, Data Access, and Public Trust. IOM recommended that a subcommittee of

    NVAC advise CDC on the Vaccine Safety Datalink (VSD) Project research agenda. Because carrying out high-quality research requires integration across the ISO research and surveillance components, the scope of the research agenda being developed will include the full ISO research agenda, including the VSD Project.

    In this context, ISO collaborated with NVPO to obtain input from scientists representing vaccine manufacturers to inform development of the ISO draft research agenda before the NVAC scientific review. NVPO organized an individual simultaneous consultation with vaccine manufacturers and federal scientists. Two representatives from each manufacturer with vaccines that were licensed (as of August 24, 2007) in the United States and routinely used in the civilian population were invited. Scientists from other agencies and operating divisions of HHS who serve on the Interagency Vaccine Group (IAVG) were also invited to attend. Participants received briefing material before the meeting that included a charge and lists of current ISO scientific activities.

    The meeting convened in the Humphrey Building, Washington DC at

    approximately 9 am on November 16, 2007. It followed the agenda provided in the Appendix (A), with a few minor changes to accommodate the schedule. Dr. Salmon led the meeting and Dr. Snider moderated the group discussions. During the meeting Dr. Broder reminded manufacturers’ representatives of the goal to obtain individual input

    from the participants, rather than a consensus. Participants were encouraged to speak freely and were informed that documents would note the ideas that were discussed without using names. In addition they were asked to complete anonymous feedback worksheets at the end of each brainstorming session. These were summarized by Dr. Broder (Appendix B).

     1 Terms in the document reflect those that were in use at the time of the meeting on 11/16/2007. Disclaimer This document does not represent Centers for Disease Control and Prevention (CDC) or 2

    National Vaccine Program Office (NVPO) policy, nor does it necessarily reflect which ideas will be incorporated into CDC’s final Immunization Safety Office Scientific Agenda. This document has

    been reviewed by meeting participants.

Meeting Events and Discussion

Welcome From the NVPOBruce Gellin and Daniel Salmon

Dr. Gellin thanked the participants for coming. He stressed the importance of input from 2vaccine manufacturer representatives in the development of the ISO Research Agenda.

    The process of putting together that Agenda with input from federal agencies and stakeholders stems from a 2005 Institute of Medicine (IOM) recommendation for NVAC to review and provide advice on the Vaccine Safety Datalink (VSD) research plan. That charge has been expanded to include the ISO scientific activities as a whole.

    Dr. Salmon informed participants that they were encouraged to complete worksheets at the end of the brainstorming session. The participants would be asked to note research topics in each of the areas addressed during the meeting. He asked that any ideas for research topics that occurred to the participants after the meeting should be sent to him or to Drs. John Iskander or Karen Broder.

Welcome from the ISOJohn Iskander

    Dr. Iskander provided background information on the ISO Research Agenda as a context for the present meeting. Since 2005, the ISO’s mission has focused on vaccine risk assessment although it remains engaged in broader science and policy initiatives concerned with vaccine safety.

    Dr. Iskander noted a series of IOM reports on the assessment of the possible causal relationship between vaccines and adverse events in the 1980's and 1990's that found inadequate scientific evidence to determine whether or not a causal relationship existed in more than half of safety concerns investigated. IOM determined that this finding was due to limitations in knowledge and research capacity.

    Gaps in vaccine safety knowledge persist because of the rarity of serious adverse events, the difficulty of performing high-quality scientific studies, the relative newness of vaccine safety science, and the broad scope of the field. There is, therefore, a need to collect, organize, and prioritize vaccine safety studies.

     2 The ISO Research Agenda is also referred to as the “Agenda” in this document.

    Disclaimer This document does not represent Centers for Disease Control and Prevention (CDC) or 3

    National Vaccine Program Office (NVPO) policy, nor does it necessarily reflect which ideas will be incorporated into CDC’s final Immunization Safety Office Scientific Agenda. This document has

    been reviewed by meeting participants.

ISO Research Agenda Development: Process and Discussion Framework

    Karen Broder

Dr. Broder spoke about the ISO’s Research Agenda development process. First, CDC

    will develop a draft research agenda with input from scientists with diverse expertise. Today’s meeting is the last component of this first phase. Earlier input was received

    from other Department of Health and Human Services and Department of Defense agencies (8/2007) and programs and from an external scientific consultancy (5/2007).

    The input will be synthesized, and the key research themes prioritized to develop an ISO draft ISO Research Agenda. After this draft is complete, NVAC will facilitate a scientific review of the draft Research Agenda. CDC will have an opportunity to respond to the NVAC feedback and will finalize the Agenda.

    Dr. Broder also spoke about the mission of the ISO, the interrelationships of its main research and surveillance components, and the general research themes that had emerged from the earlier input from external consultants and federal scientists. These themes included research on specific vaccines, vaccination practices, host factors (e.g., genomics), clinical outcomes, vaccine adjuvants and nonantigen components, and risk perception.

The charge to the manufacturers’ representatives was similar to that given to the previous

    groups. They should identify vaccine safety research areas and gaps in knowledge that are or will be important for public health and could be studied by the ISO. They were also encouraged to indicate why these topics are important, suggest feasible approaches to their study them, and advise ISO as to their relative priority.

Objectives and Format for the DayDixie Snider

    The meeting was divided into five brainstorming sessions: One on vaccine adjuvants and other nonantigen vaccine components and new vaccine technologies and four sessions divided according to life stages of the vaccine recipients (Appendix A).

Discussion

    In response to a question, Dr. Snider said that a report will be generated from the series of discussions and will be in the public domain.

    One participant noted that the data could be useful in the creation of physician guidance. The example offered had to do with immunocompromised children inappropriately vaccinated.

Disclaimer This document does not represent Centers for Disease Control and Prevention (CDC) or 4

    National Vaccine Program Office (NVPO) policy, nor does it necessarily reflect which ideas will be incorporated into CDC’s final Immunization Safety Office Scientific Agenda. This document has

    been reviewed by meeting participants.

Another participant hoped that there would be FDA “buy-in” to the current solicitation of

    input from manufacturers. Dr. Snider replied that the ISO would be working with the FDA. He noted that there is some overlap of interest between the two bodies but that ISO’s primary concern is the safety of vaccines already being used in the national vaccine program rather than with the approval of new individual vaccines as they emerge from Phase III clinical trials.

    The question was raised whether vaccine failure is a safety issue. Dr. Iskander replied that although there is the potential for overlap, most studies are focused primarily on either safety or efficacy. For example, VSD conducts influenza vaccine efficacy studies that are separate from VSD influenza vaccine safety studies. We will also look to international standards (e.g. Council for International Organizations of Medical Sciences) for guidance.

    Brainstorming Session 1: Vaccine Adjuvants, Other Nonantigen Vaccine Components, and New Vaccine Technologies

    The following were suggested as areas for research or topics of concern:

    ; VSD and the Vaccine Adverse Event Reporting System (VAERS) are not

    designed to assess whether events are transient or long-lasting outcomes. It

    would seem important to assess the severity and duration of an event as well as its

    incidence in order to judge its importance.

    ; Although clinical trials may be considered by some to be the gold standard, they

    aren’t always easy to interpret. There are a lot of confounding variables in

    clinical trials; for example, the patient dropout rate may be due to anxiety related

    events rather than to anything intrinsic to a specific vaccine.

    ; In clinical studies, false signals can also appear. In addition, when studies are put

    on hold because of concern about an adverse event, other patients are lost to the

    study, making the final interpretation more difficult.

    ; New adjuvants are undergoing a degree of scrutiny not applied to alum, an

    existing adjuvant. This scrutiny may obscure the benefit of new adjuvants.

    ; A database of background adverse event rates might help in deciding which

    outcomes after vaccination warrant further study.

    ; Because of proprietary or confidentiality concerns, manufacturers are sometimes

    told by regulators to look at particular adverse events or groups of events without

    knowing any of the specifics (e.g., the reason for the concern, what factors to look

    for). More open communication from manufacturers should be provided about

    the frequency of the event and the biological relationship with the specific