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Recommendations on the 2008 Draft National Vaccine Plan

National Vaccine Advisory Committee

DRAFT February 5, 2010

The National Vaccine Program Office (NVPO) is coordinating the update of the National Vaccine Plan (NVP), last issued in 1994.  In 2008, a draft National Vaccine Plan was released for comment.  The draft plan is primarily the result of deliberation, analysis, and input from multiple Federal agencies under the coordination of the NVPO; additional input on the draft plan is currently being sought from a broad range of stakeholders and the general public. 

The National Vaccine Advisory Committee (NVAC) has assisted in this review by hosting a one-day stakeholder meeting and three one-day public engagement meetings in 2009.  The NVAC also provided comments to the Institute of Medicine (IOM), which had been engaged by NVPO to conduct a comprehensive review of the draft NVP, focusing specifically on the need for better organization and coordination of National Vaccine Program efforts along with an appropriate level of authority and resources.  The IOM issued its report on the draft National Vaccine Plan in November, 2009. 

In January 2010, the Assistant Secretary for Health (ASH) requested that the NVAC make recommendations to him on the draft National Vaccine Plan, taking into account the recommendations in the IOM report, to inform the next draft of the National Vaccine Plan.  The ASH also requested that the NVAC prioritize the goals in the draft Plan.  On its January 20, 2010 public meeting conference call, the NVAC reviewed the IOM criteria for prioritization of the Plan goals and added one additional criterion (see below).   A template was then circulated to NVAC members for them to comment on the draft Plan goals and the IOM recommendations, to identify remaining gaps, and to prioritize goals in the plan.   These were discussed during its February 3-4, 2010 NVAC meeting.  Based on these discussions, a final set of recommendations was developed for discussion and adoption on the February 26, 2010 NVAC public meeting conference call. 

These recommendations were approved at the February 26 meeting and will be transmitted to the ASH for his review and consideration of options for their implementation.

General Recommendations

1.              The NVAC agrees with the IOM finding that there needs to be clear assignment of authority, responsibilities and resources to achieve the goals of the National Vaccine Plan.  The NVAC, in its 2008 State of the Program Report stated “NVP should be given the resources and effective organizational authority within HHS to carry out its mission.”  The NVAC believes that under the current HHS structure, only the Secretary of HHS commands this authority.  The NVAC agrees that the National Vaccine Plan needs to serve as the primary planning tool for all components of the National Vaccine Program.  The NVAC recommends that the IOM Recommended Goal 6 – Coordination – be moved to be the first Goal of the National Vaccine Plan. 

 

2.              The NVAC endorses the recommendations made by the IOM, with the exceptions listed
here:
 

a.         IOM Recommendation 1.4, to include therapeutic vaccines in future iterations of the National Vaccine Plan should not be included.  Advances in this important, but very different, area of vaccines should continue to be monitored and re-evaluated if indicated.;

b.         IOM Recommendation 2.3, to establish a permanent NVAC vaccine safety subcommittee should not be specified in the Plan because the NVAC Vaccine Safety Working Group is currently meeting to make a recommendation on how to best structure oversight of vaccine safety in the US.

         The NVAC recommends that the NVPO and other Federal staff developing the National   Vaccine Plan strongly consider implementation of all other IOM recommendations into the next revision of the Plan.  Comments about specific IOM recommendations are presented below, within their appropriate goal.

3.              The NVAC recommends the following criteria for evaluation and prioritization of the National Vaccine Plan.  These criteria are: 1) potential impact on morbidity and mortality, 2) feasibility (technical and financial), 3) strategic opportunity, and 4) public salience.

4.             The NVAC recommends that terms such as “independent” and “transparent” should be clearly defined in the National Vaccine Plan.

Draft 2008 National Vaccine Plan Goal 1 – Develop new and improved vaccines

5.             The NVAC endorses IOM recommendation 1.3 to incorporate improvements in the vaccine regulatory process that reflect innovation and current science without compromising efficacy and safety.  The Goal should be written to emphasize the need to develop and utilize innovative strategies to achieve these objectives. 

6.             The NVAC recommends that this goal emphasize new vaccine development continue to consider the complexity of the existing vaccination schedule to maximize compliance and ease of administration, within the bounds of scientific data available at the time of development. 

Draft 2008 National Vaccine Plan Goal 2 – Enhance the safety of vaccines and vaccination practices

7.             The NVAC endorses IOM Recommendation 2.4, to expand and strengthen vaccine safety research, and strongly urges the identification of a source of stable and predictable funding for safety research be incorporated into the Goal.


Draft 2008 National Vaccine Plan Goal 3 – Support informed decision-making by the public, providers and policy makers

8.             The NVAC recommends that an objective should be added to the Goal that establishes an ongoing public engagement process for vaccine-related topics.

9.             The NVAC recommends that National Vaccine Plan Objective 3.6, to improve the knowledge of vaccines and vaccine-preventable diseases among healthcare providers should specifically include education about vaccine safety issues.

 

Draft 2008 National Vaccine Plan Goal 4 – Ensure a stable supply of recommended vaccines and achieve better use of existing vaccines to prevent disease, disability and death in the US

10.         The NVAC endorses IOM Recommendation 4.1, to develop and implement strategies to assure a stable and adequate vaccine supply for public health preparedness and recommended routine use.  The NVAC recommends that indicators for these efforts should not focus solely on stockpiles as the way to prevent vaccine shortages.

11.         The NVAC endorses IOM Recommendation 4.5 that the Plan assures active involvement of the NVPO and relevant partners in the planning and implementation of the national health information initiative, and recommends that this include an emphasis on universal participation in immunization registries integrated with other electronic health information technologies.

12.         The NVAC endorses IOM Recommendation 4.6, but suggests the following modifications to the recommendation: “The Plan should include strengthening the public health infrastructure to 1) support vaccine delivery, 2) measure immunization practice and performance, including vaccine management and distribution, 3) support providers with strategies and technologies to improve vaccine management and administration, 4) understand and intervene to address disparities, and 5) respond to emerging infectious disease threats.”

Draft 2008 National Vaccine Plan Goal 5 – Increase global prevention of death and disease through safe and effective vaccination

13.         The NVAC acknowledges the importance of global health, but does not believe that NVPO or NVAC, as currently constituted, have the expertise to properly address global health goals as it is currently constituted.

14.         The NVAC recommends that the staffing of the NVPO and the membership of the NVAC be expanded to include persons with expertise on global health and immunization issues.

15.         The NVAC recommends that National Vaccine Plan Objective 5.5, to support the development of regulatory environments and manufacturing capabilities that facilitate access to safe and effective vaccines in all countries, should more clearly address the need for regulatory harmonization.