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The National Vaccine Advisory Committee (NVAC)

Letter from the Chair to the Acting Assistant Secretary for Health, RE: NVAC - February 5-6, 2009 Meeting

March 11, 2009

Stephen K. Galson, M.D., M.P.H
Acting Assistant Secretary for Health
Department of Health and Human Services
200 Independence Avenue, SW, Rm. 701-H
Washington DC 20201

RE: NVAC - February 5-6, 2009 Meeting

Dear RADM Galson:

This letter is to report to you on the discussions and recommendations of the National Vaccine Advisory Committee (NVAC) at its February 2009 meeting. I am sorry you were unable to join us for the meeting, but I would like to express our thanks for having Dr. Donald Wright, Principal Deputy Assistant Secretary for Health, attend the meeting and represent your office. The meeting agenda differed from the usual format in that the second day of the meeting, February 6, was devoted to stakeholder engagement regarding the ongoing update of the National Vaccine Plan. The agenda for the meeting is enclosed.

Report of the Chair. The first day of the meeting, February 5, began with the Report of the Chair that focused on two main areas. The first topic was NVAC membership. Following this meeting, the NVAC will have five vacancies due to term expirations for four members as well as the earlier resignation of one member. Efforts are underway to appoint new members to fill these vacancies and it is hoped that there will be a full complement of NVAC members at the next NVAC meeting in June 2009.

The second area discussed was the NVAC 2008 State of the National Vaccine Program Report. The need for such a report was discussed during the September 2008 NVAC meeting. In March, a draft report was written with proposed recommendations based on the previous discussion, and circulated among NVAC members for comment. The Report gives a brief overview of the recent accomplishments and current challenges facing the immunization enterprise in the United States; details recent activities of the National Vaccine Program Office (NVPO) and NVAC; and provides the NVAC's 2008 assessment, pursuant to Section 2105 of Public Health Services (PHS) Act, of the most important areas of government and non-government cooperation that should be considered in implementing sections 2102 and 2103 of the Act. Finally, the Report provides a series of recommendations to enhance the effectiveness of both the NVPO and NVAC. The primary recommendation is that the National Vaccine Program (NVP) should be given the resources and effective organizational authority within HHS necessary to carry out its mission to coordinate and direct the vaccine-related efforts of the federal PHS agencies. Having the NVP report to the Secretary of HHS would achieve the needed organizational authority. The Report is enclosed with to this letter for your review and approval. We suggest that the Report be shared with the new leadership in HHS to apprise them of the work of this Committee and of NVPO.

Report of the Principal Deputy Assistant Secretary for Health. Following the Report of the Chair, NVAC next heard from Dr. Wright who provided his thoughts on the main items on the NVAC meeting agenda including vaccine safety, vaccine financing, the update of the National Vaccine Plan, and vaccine development. Dr. Wright also gave certificates of appreciation to four NVAC members - Dr. Jaime Fergie, Dr. Sharon Humiston, Dr. Lance Gordon, and Dr. Charles Lovell, whose terms are expiring and for whom this was their final meeting as NVAC members.

National Vaccine Plan. Next, CAPT Raymond Strikas, NVPO, updated NVAC on the revision of the National Vaccine Plan, the first since it was initially published in 1994. A draft Plan has been developed by the NVPO, with input from relevant Federal agencies. HHS has commissioned the Institute of Medicine (IOM) to review and comment on the draft Plan. IOM is hosting a series of meetings around the country to obtain expert comments on each of the Plan's primary goal areas. As part of NVAC's role to assure broad stakeholder input into vaccine policies and to help assure that the Plan is a national, not just a Federal plan, NVAC hosted a stakeholder engagement session on the second day of this NVAC meeting and also published a Federal Register notice soliciting public comments. NVAC will contribute its findings to the IOM committee. The final IOM committee report will be issued in November 2009 and will guide the development of the updated National Vaccine Plan and implementation framework, to be completed in 2010. Following Dr. Strikas' presentation, Dr. Lance Gordon spoke of his experience attending an IOM engagement meeting in December 2008, and encouraged other NVAC members to attend these meetings if possible. The Committee discussion that followed identified gaps in the current draft Plan regarding the need for better coordination of vaccine-related activities and resources within the Federal government as well as the continued need to fully engage stakeholders and non-governmental partners. NVAC directed the Chair to draft a letter to be submitted to the IOM committee specifying language that NVAC feels is necessary for inclusion in the National Vaccine Plan to assure that coordination of governmental and non-governmental vaccine-related activities, including adequate resources to carry this out, is an integral part of the Plan.

NVAC Evaluation. Dr. Jeanne Ringel, RAND Corporation, presented the status of an external evaluation of the NVAC currently being conducted by RAND. The purpose of this evaluation is to identify the factors associated with implementation of NVAC recommendations and to develop strategies to increase the effectiveness of NVAC recommendations with regard to vaccine policy. Currently, all NVAC recommendations since 1998 have been cataloged and the results of their implementation are being examined. Additionally, interviews with key stakeholders, decision makers, current and prior committee members, etc., will begin soon. The final report will be delivered to the NVAC by the end of June 2009, with a presentation of the draft report at the June 2009 NVAC meeting.

NVAC Vaccine Safety Working Group (VSWG) update. Dr. Andy Pavia, chair of the VSWG presented an overview of its current activities. The WG is focused on reviewing the Centers for Disease Control and Prevention (CDC) Immunization Safety Office (ISO) draft scientific research agenda. To assure public input regarding general perceptions of vaccine safety issues, the Keystone Center is conducting public engagement sessions. Ms. Janesse Brewer, Keystone Center, presented a summary of three public engagement sessions that Keystone facilitated in Birmingham AL, Ashland OR, and Indianapolis IN. While these sessions did not involve representative samples of their respective populations, the focus group style meetings did help generate discussion and ideas on values related to vaccines and vaccine safety which will be incorporated into the Working Group's recommendations on the ISO scientific agenda. A final report from these community meetings is being prepared by the Keystone Center. Dr. Pavia then summarized the outcomes of a day-long VSWG meeting that took place on February 4, 2009. The morning session was a public meeting where public input was sought on an initial set of draft recommendations on the CDC ISO research agenda developed by the WG. The afternoon was a closed meeting of the WG. One immediate action item that was indentified by the WG was the need for the NIH-sponsored National Children's Study (NCS) to collect medical record data on vaccination histories in order to improve the accuracy of the data, rather than rely on parental recall of vaccinations, which is the current plan. The NCS is a tremendous opportunity to study possible safety issues related to childhood vaccines in a well designed, representative cohort study. NVAC agreed with this concern and directed the Chair to draft a letter to NIH expressing this concern.

NVAC Vaccine Finance Working Group update. As part of the approval of the NVAC Vaccine Finance Working Group (VFWG) recommendations in September 2008, NVAC requested that NVPO develop cost estimates for each of the recommendations for presentation at this meeting. These estimates do not alter the approved recommendations, but were generated as a follow-up activity linked to the implementation of the recommendations. The cost estimates were presented by CDR Angela Shen, NVPO, and Dr. Lance Rodewald, CDC. Some estimates have not been fully developed, and further refinement will be done with final cost estimates to be presented when completed.

NVAC Adult Immunization Working Group update. Dr. Richard Clover, Chair of the NVAC Adult Immunization Working Group, reviewed the work of the group to date. The WG has been meeting with HHS and other Federal agencies (Veterans Administration, Department of Defense) who have a stake in adult immunizations. A set of preliminary recommendations based on these reviews of adult immunization programs is being developed. A final set of WG recommendations is expected to be presented at the June 2009 NVAC meeting.

Influenza update. CAPT Anthony Fiore, CDC, provided a summary of the 2008-2009 US influenza season. To date, widespread influenza activity has been limited to a few states and the match between the vaccine strains and the circulating strains has generally been very good. However, antiviral resistance in circulating strain has been a problem this season. CDC has issued interim guidance on antiviral treatment of influenza. Dr. Andy Pavia then provided background related to the National Biodefense Science Board (NBSB) pre-pandemic influenza vaccination policy. Discussions are underway to examine the possibility of using stockpiled H5N1 vaccine in a pre-pandemic setting, to prepare for a possible pandemic. It was suggested that an NVAC representative take part in these discussions as a member of the NBSB pre-pandemic influenza vaccination working group.

Pediatric Vaccine Stockpiling. CAPT Abigail Shefer, CDC, presented the current status of the pediatric vaccine stockpile coordinated by CDC. This issue has been discussed at several recent NVAC meetings, including reports at the last two meetings on mathematical models looking at the need and adequacy of stockpiles for each antigen. Currently, the stockpile is designed to be a six month national supply for Vaccines for Children (VFC) program-eligible children only. The concern of stockpiling only VFC-related vaccines led to discussions about the best way to proceed with the development of a pediatric vaccine stockpile. An NVAC working group will be formed to address this issue.

Vaccine Innovations and Development. CDR Angela Shen, NVPO, presented an overview of the vaccine development process, with a focus on efforts to improve vaccine innovation, particularly for vaccines with limited markets, similar to "orphan drug" development. This was followed by a presentation from Dr. Robin Robinson, Director, Biomedical Advance Research and Development Authority (BARDA), on the recent development of preparedness-related vaccines (e.g., smallpox, anthrax) as well as the activities related to pandemic influenza vaccine research and development, stockpiling, and infrastructure development.

NVAC Stakeholder Session on the National Vaccine Plan. The second day of the NVAC meeting was devoted to obtaining public and stakeholder input into the draft National Vaccine Plan. The meeting opened with an introduction by Dr. Bruce Gellin and myself on the purpose and need for working with stakeholders during the update of the National Vaccine Plan. Then CAPT Raymond Strikas, NVPO, provided an overview on the process of updating the National Vaccine Plan.

For the remainder of the morning session, break-out groups were formed to obtain stakeholder input on each of the five primary goals of the Plan. These include: (1) Develop new and improved vaccines; (2) Enhance the safety of vaccines and vaccination practices; (3) Support informed vaccine decision-making by the public, providers, and policy-makers; (4) Ensure a stable supply of recommended vaccines and achieve better use of existing vaccines to prevent disease, disability and death in the US; and (5) Increase global prevention of death and disease through safe and effective vaccination. The first part of the afternoon was spent in small groups defined by stakeholder sector. These included: (1) vaccine industry and vaccine researchers; (2) public health organizations; (3) health professional organizations; (4) health care payers and plans; and (5) other groups.

The key points of each discussion group were summarized and presented to the full Committee, with time for discussion and public comment. After a final discussion and public comment period, the meeting was adjourned.

Please feel free to contact me with any questions or concerns you may have in regard to any of the Committee's activities. I would also like to invite you to attend our next meeting, which is scheduled for June 2-3, 2009. Of course, I am available at any time to speak to you by telephone or to meet in person.



/Guthrie S. Birkhead/
Guthrie S. Birkhead, M.D., M.P.H.
Chair, National Vaccine Advisory Committee