The National Vaccine Advisory Committee (NVAC)
National Vaccine Advisory Committee (NVAC)
Committee Members in Attendance
NVAC Ex Officio Members
NVAC Liaison Representatives
Committee Members Absent
Opening Remarks, Introduction, and Report of the Chair�Dr. Guthrie Birkhead
Presentation of the NVAC Vaccine Safety Working Group draft report�Dr. Daniel Salmon
A robust public engagement process occurred. The Keystone Center facilitated public and stakeholder engagement, including three community meetings in Birmingham, AL, Ashland, OR, and Indianapolis, IN. Ashland, OR was chosen for its high rates of vaccine exemptions. There was also a Writing Group meeting in Salt Lake City with a variety of stakeholders who drafted materials for additional stakeholder consideration at the March 16, 2009 stakeholder meeting in Washington D.C. There were two formal solicitations for written comments; both made available through notices in the Federal Register.
A vote on the recommendations is anticipated for the June NVAC meeting. If passed, the recommendations will be given to the Assistant Secretary for Health (ASH), and the ASH can communicate the recommendations to CDC/ISO.
Dr. Salmon described the prioritization criteria used by the Working Group and reviewed the 32 recommendations of the Working Group. Criteria used to prioritize included consideration of the significance of the exposure to a vaccine, burden of the adverse health event following immunization, public concern, scientific concern and degree to which science warrants further study, impact on policy, and feasibility of study (Appendix 1). The first five criteria consider "what to do," while the last considers "how to do it." For each of these criteria, the specific vaccine safety questions were rated low, medium, or high.
Dr. Salmon discussed two overarching issues for the Vaccine Safety Working Group: 1) the constraints of looking at the draft ISO Scientific Agenda in isolation, as ISO/CDC is only one component of federal vaccine safety system, and 2) the belief that emphasis should be placed on the prevention of vaccine adverse events, and if not possible, amelioration of those events.
Dr. Salmon read through the nine general recommendations, eight capacity recommendations, and 15 research recommendations (Appendix 2). He described how the prioritization criteria were applied by the Working Group to each specific vaccine safety questions (Appendix 3). For each of the five prioritization criteria, the proportion is given of Working Group members who rated the topic high, medium, or low as well as the proportion believing each study is feasible. Dr. Salmon used the question, "Is exposure to thimerosal associated with increased risk for clinically important tics, Tourette syndrome, and/or speech and language delays?" as an example. The overall priority rating was low, and since thimerosal has been taken out of most vaccines in all but trace amounts, the overall amount of exposure, and thus significance of exposure in the U.S., was low. Furthermore, the impact on policy of any study would also be low. This question received a low priority overall, but the Working Group did recommend further analysis of the Thompson study (Thompson WW et al. N Engl J Med 2007;357(13):1281-92). Because the marginal cost would be low, it was considered an important item.
Dr. Pavia thanked everyone for their hard work, including the Working Group members, NVPO staff, and everyone who participated in the community and stakeholder meetings. Dr. Salmon explained that there were two subsequent Working Group calls scheduled, one to discuss NVAC comments and one to discuss public comments, after which the report would be revised as appropriate. Those changes would be highlighted to the NVAC at the June meeting, when a vote is anticipated. The call was opened up to questions and comments from NVAC members on the presentation or on the report itself. Dr. Rawlins asked if there would be a communications strategy around publicizing the results of vaccine safety studies. Dr. Salmon responded that this is not part of the first charge. The second charge to the Working Group, which will start with a kick off meeting July 15-16, 2009, in Washington DC, is to look at the system more broadly; the Working Group may decide to include discussion of communications when addressing the second charge.
Dr. Morse commented from the ACIP perspective. There were two issues that have come up at ACIP meetings. The first is the importance of VSD. Dr. Pavia noted in the report that it would be addressed more fully in the second charge. Because the VSD is so much more valuable than the Vaccine Adverse Event Reporting System (VAERS), Dr. Morse said he would like it to be enhanced. The second issue is the absence of research on vaccine safety during pregnancy; while it is mentioned in Special Populations section, Dr. Morse would have liked to see a subcategory that covers the need for further research on vaccine safety in pregnancy. Dr. Pavia noted that while identifying a population as special is a start, a research agenda should start to develop what the questions are and how to answer them. The Working Group therefore recommended that CDC better define what they specifically hope to study.
Dr. Dekker reported feedback from CISA investigators that because the Working Group only prioritized the specific vaccine safety questions, some people are tending to focus on those. It may be important to better emphasize that these are not the only priorities, and not to the exclusion of research in the topical areas. Dr. Pavia explained that the Working Group had long discussions over whether it was possible to prioritize sections B-D but came to the conclusion that the topics were too general to be appropriately prioritized. Dr. Gordon pointed out that it also highlights the need for periodic review, so that research questions on non-specific areas be formulated and those should be prioritized in future rounds of review. It was decided to highlight this point in the executive summary.
Dr. Birkhead asked the NVAC members if they felt that the prioritization approach was reasonable. Dr. Rawlins and Dr. Almquist agreed that it was the right approach.
Dr. Fergie commented that the background should frame the discussion of ISO with a few comments on pre-licensure safety evaluation, and how the results of post-licensure safety studies feedback to the FDA. Dr. Gordon agreed, noting that the report should differentiate the types of questions that can only be answered post-licensure, and why. There was some discussion about how much background to insert. A few sentences or a paragraph were felt to be sufficient. This can also be emphasized in the report where the Working Group recommends ISO coordinate with other agencies. Dr. Salmon recommended page 14 for this statement, and everyone agreed.
Dr. Dekker noted a comment from a CISA Principal Investigator that it would be good to emphasize the benefits of vaccination.
Dr. Birkhead asked for additional comments from the NVAC by noon on Monday, May 11th, 2009, for the Working Group to discuss on their next call on Tuesday, May 12th. Ms. Vannice reported that there had been few public comments received to date, but she expected more prior to the deadline for submission, which is Wednesday, May 13th.
Dr. Almquist noted that in the executive summary, there are some acronyms that are not identified and recommended a page listing all of the acronyms be added.
Dr. Birkhead then opened the call for comments from public attendees.
Jim Moody, SafeMinds
Dr. Birkhead thanked Mr. Moody for his comments and noted that the feasibility study has been a major topic of discussion. The National Children's Study is not part of ISO's research, but NVAC has taken a strong stance that immunization histories from medical records be obtained. Dr. Pavia said this will also be tackled in charge 2.
Rebecca Estepp, Talking About Curing Autism
Dr. Broder pointed out that simultaneous vaccination was originally part of the initial ISO draft Scientific Agenda. Dr. Pavia reminded everyone that the Working Group does not execute studies, only makes recommendations to ISO.
Dr. Birkhead thanked everyone for all of their work and reminded NVAC members to send additional comments on the draft report. Dr. Pavia also thanked Janesse Brewer and The Keystone Center for their tremendous work getting public input. Dr. Salmon also thanked the Working Group for all of their time. Dr. Birkhead closed the meeting.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Appendix 1. Prioritization criteria used by the Vaccine Safety Working Group.
Appendix 2. Summary of Recommendations
Appendix 3. Summary of the Vaccine Safety Working Group's prioritization of Specific Vaccine Safety Questions in the draft ISO Scientific Agenda.
Percentages represent proportion of Working Group members who rated a question in the high, medium, or low category for each of the Step 1 criteria, and a yes or no in the Step 2 criteria.