National Vaccine Advisory Committee (nvac)

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NVAC Public Health Options Working Group Update - Dr. Don Williamson

Dr. Williamson noted that NVAC had seen his slides before and that the working group had taken discussions as far as they could. The discussion began 5 to 6 years ago and came about because the cost of Prevnar was as much as the all the rest of the recommended immunization series combined. States were being confronted with whether they should require certain vaccines (i.e., hepatitis B, Varicella, Prevnar) and how they should make those decisions. Out of this issue, there was a need to quantify and clarify how they currently make immunization recommendations and how to better identify a framework for states to use to make these decisions. He clarified that this was not to give states a cookbook path that they had to take, but rather a framework of issues that states should consider to defend their decisions, recognizing that decisions can differ by state. As a result, ASTHO came to NVAC. A working group was convened, literature was reviewed, and hearings were held.

Dr. Williamson noted that the working group agreed on some broad principles, but fundamental differences remained. Some members of the working group, such as himself, believed that immunization mandates have worked well and are an important tool of public health. Others would suggest that in today’s environment, strategies, which take into account more personal choice and philosophical exemptions should be given more weight. The working group crafted a list of broadly based recommendations that allow a lot of flexibility on a state-by-state basis, while still providing the framework that ASTHO was looking for at the beginning of the process. The working group’s intention is to give the recommendations to NVAC and let the committee decide what to do with them.

The first recommendation was that states should consider a variety of factors taking into account public health, public policy, and operational environments within their own jurisdiction. They should specifically focus on the nature of the disease – the risk of morbidity, disability, and mortality; population at risk; risk of transmission in specific settings (e.g., schools, hospitals, households); risk for outbreaks; cost of disease; etc. They should focus on vaccine-related issues for the individual and the community in terms of the efficacy of disease prevention, risks of vaccine-related adverse events, accessibility of target populations, how it fits in with national recommendations, and in some states, financial considerations because some states require that if you mandate a vaccine, you must also pay for it. States should also consider issues of personal choice such as: the degree of societal consensus around the vaccine; feasibility of enforcemen;, and some weighing of autonomy and the freedom to choose or refuse vaccine.

The second recommendation was that states should consider certain underlying principles. A variety of strategies are useful in implementing vaccine recommendations and there is no single strategy to achieve high immunization levels. Optimal approaches balance population protection and adverse events, while respecting personal choice. Requirements may be most appropriate for diseases with the highest associated morbidity, transmissibility, and potential for costly and socially disruptive outbreaks.

The third recommendation was that the development of state policies and programs is a public process and should incorporate appropriate participation from stakeholders and be consistent with the state’s regulatory and legislative environment. This process is very different from state-to-state and depends on the culture of state. The concept of stakeholder participation is important to ensure that while there is public access, there is not overrepresentation of minority opinions in the deliberative process.

It is not only important to identify the recommendations, but the implementation plan is important as well. The fourth recommendation was that state and local health officials should develop an implementation plan for state immunization recommendations and requirements, and that implementers should participate. He gave the example that public health officials have often implemented requirements without timing the recommendations to coincide with school years and effective implementation strategies for schools. The plan should address procedure for implementation enforcement, exemptions, and monitoring of disease, exemptions, and coverage. For example, it is better to enforce requirements on the front end rather than wait until children are in school since most schools are reimbursed by their educational organizations on per child per day attendance and they could lose money for enforcing immunization requirements after school starts.

The fifth recommendation was that stakeholders should be educated about benefits and risks. School officials and providers should be supported. The provider community should be worked with to get their active involvement and endorsement. They should work with consumers so that they affirmatively understand the benefits of the vaccination and if it is a mandatory vaccination, the consequences of not being vaccinated should there be an outbreak.

The sixth recommendation was that exemption provisions should respect parental choice while maintaining high coverage. While all but two states have religious exemptions, most do not have a test for that religious exemption. Few states permit philosophical exemptions, but in almost all states, religious exemptions become philosophical exemptions because of the level of test that is applied for religious exemptions. They should develop and implement procedures to ensure that compliance with requirements through receiving vaccinations is at least as easy as obtaining exemptions. They should minimize economic and access barriers to get at states with fiduciary obligations to provide the vaccine.

The seventh recommendation was that they should develop exemption procedures that facilitate informed decision-making. All parents considering non-medical exemptions should be educated on the risks and benefits of vaccination. People who choose to decline the vaccine or choose an exemption need to understand the consequences to their children if there is an outbreak and they have not been vaccinated.

The eighth recommendation was that state health departments should work with school officials to remove financial disincentives for enforcement of school entry requirements. They need to find a way that school systems are not financially penalized for enforcing immunization requirements.

The ninth recommendation was that states should monitor and evaluate their implementation of requirements and revise them accordingly. While states know their school immunization rates and exemption rates, they can not differentiate between medical and non-medical exemptions. Exemption data need to be compiled at the state and local levels, and CDC should be engaged at the national level to improve reporting exemption rates by exemption category.

The tenth recommendation was that CDC should summarize and report exemption data submitted by the states and provide technical assistance.

The eleventh and final recommendation was that, recognizing that there is still knowledge to be gained, research should be conducted to develop new knowledge on effective strategies other than requirements and aspects of requirements (e.g., effective implementation, effective enforcement, representative participation, and impact on public and professional attitudes).

Dr. Williamson noted that the recommendations were broad enough that they could reach consensus and were relatively non-controversial, and that they provide a framework for states and serve as a guide for decision-making.

Discussion and Public Comment

Dr. Helms noted that Dr. Hinman had made changes to the Committee’s comments on the DHHS draft Pandemic Influenza Preparedness and Response Plan, based on the Committee’s discussion earlier in the day.

  1. A second bullet was added under the policy decisions that need to be discussed, saying that indemnification of vaccine manufacturers and those who administer vaccine and adequate compensation to those who experience serious adverse effects as a result of vaccination.

  1. The change in the last bullet was that the plan should describe linkages to general health preparedness activities to bring together the related streams of activities.

  1. The final paragraph was changed to say that based on these observations, NVAC feels the most important thing it can do is provide a mechanism for full discussion of the key policy and priority issues so decisions can be made before the pandemic occurs. This discussion should involve a wide range of stakeholders. Given that we cannot predict when the pandemic will occur, it is important to begin the process immediately. Consequently, NVAC is establishing a pandemic influenza working group that will include NVAC members and other stakeholder representatives to carry out the widespread public discussions and make policy recommendations by June 30, 2005. These recommendations will include recommendations for ongoing review of the plan and needed modification as the situation evolves.

Dr. Helms asked if members were comfortable with the changes.

Dr. Guerra noted that they might lose something in the last bullet, although it did capture some of the earlier discussion. He explained that he tried to put it into the context of the whole new system and infrastructure that is evolving related to preparedness with respect to other threats (e.g., bio-terrorism).

Dr. Hinman asked if Dr. Guerra was referring to overall preparedness activities. He noted if approved, the next step would be to form a working group and a charge, etc.

Dr. Klein noted that in light of the day’s events and though addressed in the document, he would like some of the emphasis to be that the third bullet on the first page is generically applicable to annual immunization as well as pandemic preparedness. He noted that this comes out in the top paragraph of the next page in the middle and that it would be preferable to put it at the beginning or the end that these recommendations would be valid for every year. These issues should be pushed not just for a pandemic but also for the entire influenza immunization program.

Dr. Hinman noted that they are responding specifically to the pandemic influenza preparedness plan. There is a qualitative difference between dealing with pandemic versus annual issues.

Dr. Klein suggested putting it at the end rather in than in the middle so that there is the recognition that it is not just another bullet. Dr. Hinman responded that they could make it the last bullet.

Ms. Marcus Levine suggested that the working group be made up of exclusively NVAC members, but that people from the outside could be consulted and provide input.

Dr. Hinman noted that it was his understanding that NVAC subcommittees could only include NVAC members, but that working groups could include non-NVAC members. He noted that this has been the pattern in the past – the IOM financing immunization working group and the registry working group both contain non-NVAC members.

Ms. Levine responded that her recommendation was the safer approach because working groups are not specifically addressed under FACA – only subcommittees.

Dr. Helms noted that they are involved more as consultants.

Dr. Hinman agreed to make the change.

Dr. Curlin noted that NVAC was responding to a plan developed by the Department and asked whether Dr. Hinman had cleared this additional mission with the department. Dr. Hinman responded that this is completely contained in the existing NVAC charter.

Dr. Helms noted that there is nothing specific in the NVAC charter about pandemic influenza, that it is a vaccine-preventable disease, and that there are many issues regarding the plan that deal with use of vaccine. He did not see this as a stretch of the charter.

Ms. Levine noted that they are providing notice to the Department of their intentions and that the Department would communicate any concerns that they might have.

Dr. Hinman made a motion to adopt the NVAC’s Comments on the DHHS draft Pandemic Influenza Preparedness and Response Plan as amended. Dr. Klein seconded the motion. All members were in favor.

Dr. Hinman agreed to make the revisions and have copies for NVAC the following morning.

Dr. Helms then adjourned the meeting for the day.

Day 2 – October 6, 2004

Dr. Helms began with some general topics. He noted that the committee members should have a copy of the formal comments on the Pandemic Influenza Preparedness and Response Plan, which will be provided to Asst. Secretary Beato. Based on a recommendation of the comments, Dr. Helms will be creating a working group. Those that are interested in participating in the working group should contact Dr. Helms or Dr. Gellin. The working group will need to produce policies and recommendations by June 30, 2005.

Dr. Helms noted that the minutes from the previous meeting are now available. Dr. Evans has reviewed and approved them. Dr. Klein motioned to accept the minutes, and Ms. Koslap-Petraco seconded. All voted in favor of approving the minutes.

He commented that it might be helpful to provide two-page summary on the supply issues to Dr. Beato. The summary will be drafted by Dr. Klein.

Dr. Arvin noted that the summary to Dr. Beato could include specific information on the special issues about flu, including difficulty in stockpiling and increasing manufacturing.

Dr. Gellin added that they have hired a consulting firm, PRTM, to look at the influenza vaccine industry to determine possible government incentives to diversify manufacturing technology, with a particular focus on domestic production.

Subcommittee Updates and Reports

Immunization Coverage Subcommittee and Future Vaccines Subcommittee –

Dr. Patricia Whitley-Williams

Dr. Whitley-Williams noted that the joint subcommittee meeting discussed adolescent immunization. The reason for the meeting was that as future vaccines are being developed for use in adolescents, there are concerns about the capacity to reach and immunize the majority of adolescents. The purpose was to seek comment and collaboration in the planning of a National Stakeholder Meeting on Strategies to Increase the Uptake of New Vaccines for Adolescents. The future vaccines include MCV, Tdap, HPV, HSV, CMV, and HIV.

There are four goals of the National Stakeholder Meeting. First, identify the strengths and weaknesses of key implementation strategies and issues. Second, identify approaches that will effectively and efficiently increase the proportion of adolescents who receive vaccines. Third, develop plans to implement these approaches. Fourth, identify research initiatives to support the successful introduction of new vaccines and to accelerate the development of vaccines in the pipeline.

There are also several key strategic areas and issues:

  • Delivery systems and settings—in which combination of delivery systems and settings can the new adolescent vaccines best be implemented?

  • Communications strategies—what communications strategies are most appropriate and effective?

  • Research initiatives for future vaccines—what should the research agenda be for future vaccines for adolescents and what is the role of novel vaccine delivery systems (i.e., needle-less systems) for delivery of vaccines to adolescents?

  • Integration with other adolescent health priorities—how can vaccination be integrated with other adolescent health priorities?

  • Financing and other important barriers—how should adolescent vaccination efforts be financed?

  • Immunization regulations and other mandates—when and how should immunization regulations and other mandates be used to increase the uptake of new vaccines?

  • Consent—are there new approaches to obtaining consent?

  • Appropriate roles and responsibilities (local, state, and federal)—what are the appropriate roles and responsibilities of local, state, and federal public health officials?

  • Novel vaccine delivery systems

The stakeholders include:

  • Provider organizations, including AAP, SAM, AAFP, AMA, NMA, ANA, etc.

  • Non-pediatric provider organizations, including ACOG, STD clinics, etc.

  • NGOs

  • Vaccine manufacturers

  • Federal, local, and state public health agencies

The two-day meeting is tentatively scheduled for June 2005 in Washington, DC. The meeting’s organizing committee is currently seeking volunteers and is considering a co-sponsor (e.g., Society for Adolescent Medicine). The participating stakeholders will include adolescent specialists from SAM, AAP, ACIP, CDC, etc.

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