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Letter from the Chair to the Assistant Secretary for Health, RE: NVAC – February 3-4, 2010 Meeting

Howard K. Koh, M.D., M.P.H
Assistant Secretary for Health
Department of Health and Human Services
200 Independent Avenue, SW, Rm. 701-H
Washington DC 20201

RE: NVAC – February 3-4, 2010 Meeting

Dear Dr. Koh:

This letter summarizes the National Vaccine Advisory Committee (NVAC) meeting held in-person on February 3-4, 2010.  The agenda for this meeting is enclosed.

It was a pleasure to have you join the meeting and provide updates on the vaccine and immunization activities occurring in the Department of Health and Human Services (HHS) as well as other changes in the Office of Public Health and Science, HHS.  As I stated at the meeting, I really appreciated your very thoughtful extended remarks to the Committee on what you see as the mission for your office and your three priorities to make Healthy People come alive for all Americans, to reduce disparities and promote health equity, and to focus on prevention.  Let me assure you that the NVAC stands ready to support you in this mission and in achieving these priorities in any way we can.  This was the first time in my tenure on the Committee that the ASH presented this detailed a vision for the role of his office and of the NVAC. 

At this meeting, the State of the National Vaccine Program Report for 2009 was finalized and approved by the NVAC (enclosure).  The Committee also received updates on the revision of the draft National Vaccine Plan and spent significant time formulating NVAC’s comments to you on the Plan.  We hope to finalize those comments on our next public teleconference meeting on February 26.  At this meeting we also discussed implementation of previous NVAC recommendations on vaccine safety and financing, the current progress in the vaccine safety and adult immunization working groups, the state of health care reform and its potential impact on vaccination, efforts at the Centers for Disease Control and Prevention (CDC) to develop pediatric vaccine stockpiles, the communication efforts developed within the National Vaccine Program Office (NVPO), and seasonal and H1N1 influenza.

Report of the Chair

The focus of this Report was on the 2009 State of the National Vaccine Program report.  This report serves to identify key accomplishments and progress of the NVPO and NVAC, as well as to identify priority areas for the coming year.  Briefly, four priority areas for the NVAC’s work for the coming year were identified: 1) completion of the revision of the National Vaccine Plan, 2) participation in a review of the 2009 H1N1 influenza response, 3) implementation of the recommendations of the RAND report on the effectiveness of the NVAC, and 4) continued exploration of methods to increase public awareness and media coverage of NVAC activities and recommendations.

National Vaccine Plan

CAPT Raymond Strikas, NVPO, reviewed the timeline for the revision of the National Vaccine Plan and presented an overview of the key Institute of Medicine (IOM) recommendations on the priorities in the National Vaccine Plan.  Robert Bednarczyk presented a summary of the input provided by NVAC members on both the current draft of the National Vaccine Plan and the IOM recommendations.  These comments were used as the basis for discussion of formal NVAC recommendations regarding the National Vaccine Plan.  Development of these recommendations was undertaken during the meeting, and a complete set of recommendations will be presented for discussion and voting for approval at the NVAC public teleconference meeting on February 26, 2010.

Vaccine Safety

Updates on vaccine safety activities were split between three areas.  First, Dr. Andrew Pavia briefed the Committee on the work and progress of the Vaccine Safety Working Group including the information gathering process currently underway, the tentative plans to gather stakeholder input and the overall plan to complete a report or set of reports containing recommendations on improving the national vaccine safety system for a final vote by the NVAC in September 2010. 

Second, Dr. Marie McCormick presented an overview of the work and recent reports of the Vaccine Safety Risk Assessment Working Group (VSRAWG) that is conducting independent, rapid review of available immunization safety monitoring data for the 2009 H1N1 influenza vaccines.  As has been communicated to you following the December 2009 and January 2010 NVAC teleconference meetings, the VSRAWG has found that the available data are adequate to assess the presence or absence of a vaccine safety signal, the data do not favor a signal between the outcomes examined and the receipt of H1N1 influenza vaccines, and that safety monitoring should continue as more data become available.

Third, Dr. Frank DeStefano, CDC Immunization Safety Office (ISO), updated the NVAC on efforts made by the CDC ISO to address the NVAC recommendations on the ISO Scientific Agenda from June 2009.  There is strong support for these recommendations and widespread efforts are being made to implement the recommendations.  Dr. DeStefano stated that a full written response from CDC to the recommendations will be provided to the NVAC in the near future.

Update from the Assistant Secretary for Preparedness and Response

Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response, briefed the NVAC on efforts to review the response to the H1N1 influenza pandemic.  Dr. Lurie indicated that the safety of countermeasures will be a key point of the review, as will vaccine production and supply.  The role of the NVAC in this review was discussed, with a focus on coordination of other Federal advisory committees related to vaccines and engagement of stakeholders in the review process.  I would like to take this opportunity to highlight the desire of NVAC to have an active role in the H1N1 vaccine after-action assessment process. 

Vaccine Finance

CDR Angela Shen, NVPO, presented a summary of the reports of key stakeholder groups on the actions they have undertaken to address the NVAC recommendations on vaccine financing that were approved in September 2008.  This session was part of the NVAC’s efforts to revisit progress on the implementation of its recommendations to assure that they are as effective as possible. Representatives of the six stakeholder sectors (consumers; vaccine distributors and purchasers; manufacturers; federal, state and local government health departments; employers, payers and health insurers; and health care providers and related organizations) also provided detailed information about the activities that entities in their sector are performing in response to these recommendations.  Generally, speakers expressed good strong support and a number of specific actions occurring as part of the implementation of these recommendations.  However, the uncertainty of health care reform is resulting in delays in the response to some recommendations that may be addressed by proposed health care reform legislation. 

Health Care Reform and Vaccination

Ms. Caya Lewis, Office of Health Reform, provided an overview of the vaccination-related proposals in the Senate and House health care reform legislation.  Committee discussion centered on two areas – defining what was meant by Advisory Committee on Immunization Practices-recommended vaccines (e.g. routine recommendation, permissive recommendation, recommendations only for high-risk populations) and the possible impact of health care reform legislation on ERISA-exempt health insurance coverage.  The current state of health care reform and associated uncertainty precluded comprehensive responses to these concerns.

Adult Immunization

Dr. Julie Morita presented an update of the activities of the Adult Immunization Working Group towards meeting their second charge, a comprehensive examination of the national adult immunization program with associated recommendations.  Currently the Working Group is gathering data in anticipation of a future white paper with recommendations to improve adult immunization in the United States.  Dr. L.J. Tan also introduced a newly released report from the Trust for America’s Health, the Infectious Diseases Society of America, and the Robert Wood Johnson Foundation entitled “Adult Immunization: Shots to Save Lives”. 


Ms. Stephanie Marshall, NVPO, outlined the Communications Plan being developed by the NVPO, detailing the methods used to identify the best means of message delivery.  She also discussed the upcoming release of the website that will house HHS vaccination information.  This web site will combine information on vaccines from a variety of federal agency websites. This is in line with the NVAC’s and the NVPO’s long standing push for improved coordination among federal agencies on vaccine matters.  For this reason, Committee members were quite complementary of the effort and look forward to seeing the web site in action.  

Vaccine Stockpile

Dr. Lance Rodewald, CDC, updated the NVAC on efforts made to refine the Vaccines for Children program vaccine stockpile.  The major piece of this program is the stockpile target, which is a three month national supply for most vaccines, with notable exceptions such as the measles-mumps-rubella vaccine, which will have a larger stockpile amount.  As stockpiles are built to the target levels over the next five years, targets and performance of the stockpile will be re-evaluated.  While this target level is smaller than previous estimated targets, it is anticipated that performance will be similar, with less difficulty in storage and stockpile maintenance.  While there was no specific task given to NVAC from this update, it is anticipated that representatives from VFC will report back on the performance of the stockpile.

Seasonal and H1N1 Influenza

RADM Anne Schuchat, CDC, began her overview of the H1N1 update with a reminder of the uncertainty and assumptions that had to be made during the initial planning phases of the H1N1 influenza response.  She then highlighted a number of program accomplishments including the number of provider agreements signed and vaccine ship-to sites utilized.  The decline of influenza activity was discussed while emphasizing that the virus is still circulating and there is uncertainty about what will happen in the coming months.  An additional wave of influenza occurred later in the winter in one previous pandemic.  This underscores the need for maintaining vaccination efforts in the coming months.

Dr. L.J. Tan informed the NVAC about the upcoming National Influenza Summit, scheduled for May 17-19, 2010, in Scottsdale AZ. 

Dr. Vito Caserta, Health Resources and Services Administration, provided an update on the Countermeasures Injury Compensation Program (CICP).  Dr. Caserta indicated that requests for benefits can not currently be accepted or processed until the final rule is published in the Federal Register, though individuals can submit letters of intent to file to ensure that the one-year filing deadline is not missed.  As of this meeting, 65 letters of intent to seek compensation related to H1N1 influenza vaccine have been filed.

State and local partners from the National Association of County and City Health Officials, Association of State and Territorial Health Officials and Association of Immunization Managers provided updates from the perspectives of their sectors.  Key themes presented involved attempts to manage the mismatch between vaccine supply and demand, associated difficulties in managing vaccine orders and inventories, and concerns about losing gains in public health capacity and infrastructure when Public Health Emergency Response funds expire. 

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 regularly scheduled NVAC meeting, which is scheduled for June 2-3, 2010, as well as any off-schedule meetings that will be held to address the H1N1 influenza situation or the revision of the National Vaccine Plan.  Of course, I am available at any time to speak to you by telephone or to meet in person.




Guthrie S. Birkhead, M.D., M.P.H.

Chair, National Vaccine Advisory Committee