The National Vaccine Plan Update: Recent Activities and Next Steps Raymond A. Strikas, MD National Vaccine Program Office Department of Health and Human Services June 7, 2007

Presentation Outline Process to date –March 20, 2007 interagency meeting –Discussions with Assistant Secretary for Health –Review of WHO, Canada, UK, New Zealand strategic vaccine plans –June 05, 2007 interagency meeting Review of the priorities received to date –DHHS Agencies, offices, and DoD Process forward

Recommendations from 03/20/07 Interagency Meeting - 1 Incorporate HP 2010 objectives Consider public health infrastructure Provide and review ODPHP/HealthyPeople 2010 guidance document Evaluate 1994 plan with the “stake in the ground” approach. Use evaluation to identify gaps. Create a National Plan [as opposed to a federal government plan].

Recommendations from 03/20/07 Interagency Meeting - 2 Extend timelines to include stakeholders’ engagement Determine level for stakeholders’ involvment Develop “straw man” document for stakeholders Identify main purpose of the plan. Catalogue existing documents to help identify gaps Agencies should identify 5 to10 gaps

Results of Subsequent Discussion with Assistant Secretary for Health - 1 Purpose of updated Plan: –Engage in a process, with govt and non-govt stakeholders, to define challenges and opportunities, and thence goals. Identify steps to achieve the goals Process should be deliberate and may require 3 or more budget cycles Begin that involvement now to define challenges and priorities, to lead to goals –Look at diseases for which we do not have vaccines, and ask why not, as well as look for opportunities to improve current vaccines (e.g., what can adjuvants do?), e.g., improved bio-defense vaccines pandemic preparedness HIV TB Malaria –The updated plan should also include reference to Vaccine research and development Financing Safety Supply and Distribution

Results of Subsequent Discussion with Assistant Secretary for Health - 2 Process should reference the Healthy People (HP) 2020 objectives where possible, as well as the HP 2010 objectives Plan’s goals should define funding needs, but not have available funds or budget define possible goals

WHO Global Immunization Vision and Strategy Goals, Increase, then sustain coverage Reduce measles mortality by 2010 Reduce morbidity and mortality in children Ensure access to vaccines of assured quality Introduce new vaccines (and offer to all eligible within 5 years of introduction) Ensure capacity for surveillance and monitoring Strengthen systems (integrate with other health services) Assure sustainability

Other Countries’ Priorities: Canada’s 2003 National Immunization Strategy Goals Provide high, achievable and measurable coverage of publicly funded immunization programs for all Canadians. Provide complete coverage of all children with routine childhood vaccines recommended by the proposed national immunization committee. Ensure equitable access to these routinely recommended vaccines - among jurisdictions and in special populations - while considering jurisdictional program implementation differences. Promote public and professional acceptance of recommended programs. Provide optimal program safety, effectiveness and acceptance. Improve coordination and efficiency. Provide optimal cost-effectiveness and affordability of programs. Ensure security of vaccine supplies. Provide national intervention when required. [alludes to Canada’s federal system]

Other Countries’ Priorities: Canada’s National Immunization Strategy Components Immunization program planning: to support collaborative, national assessment and prioritization of new vaccines, using common criteria. Vaccine safety: to optimize the vaccine safety system, maintain professional and public confidence in the safety of vaccines, and address growing anti-immunization concerns Vaccine procurement: to ensure the best value for vaccines, the long- term security of supply for vaccines, the quality of supply, and improvements in accountability. Immunization registry network: to –Enhance national surveillance of immunization coverage rates –Facilitate transfer of and access to individual immunization records. –Measure progress towards national immunization goals and objectives. –Facilitate linkage of surveillance data of vaccine preventable diseases and vaccine-associated adverse events (VAAEs).

Other Countries’ Priorities: UK 2002 Strategy for Combating Infectious Diseases Extending the use of existing vaccines to larger numbers of people - in particular influenza vaccine and pneumococcal vaccine; Continuing to maintain high levels of coverage in the childhood immunisation programmes; Switching from oral polio immunisation to the injected form when global progress on polio eradication is at an appropriate point; Introducing available and soon to be available vaccines according to epidemiological needs and cost effectiveness, e.g. varicella vaccine, pneumococcal conjugate vaccine; Stepping up research and investment to bring forward new vaccines to prevent large or serious infectious disease problems, in particular meningococcal Group B vaccine, a vaccine against respiratory syncitial virus (one of the commonest causes of chest infection and hospital admission) and rotavirus gastroenteritis; Contributing to international research to develop a vaccine against HIV infection; Establishing a system to track vaccines using new technologies such as bar-coding; Designing new materials for the public and parents on vaccines which will be address their needs for information and will be made as widely accessible as possible through opportunities such as the internet.

Other Countries’ Priorities: Immunisation in New Zealand: Strategic Directions implement the National Immunisation Register, as a critical supporting tool for vaccinators, DHBs and the NIP; and as a basis for further implementation of electronic collection of Well Child information over time achieve a significant reduction in meningococcal B disease, through introduction of the MeNZB vaccine in 2004/05 (subject to licensure) improve access to immunisation services in primary care and outreach settings to reduce inequalities in immunisation coverage (and thus the risk of vaccine-preventable disease), prioritising equitable coverage for Maori and Pacific peoples develop an effective communication and promotion strategy for immunisation as a key component of child and adult health.

Interagency Meeting 06/05/07 Review and revision of priority Areas and Issues Review and revision of Lead and Contributing Agencies Discussion of stakeholder involvement Agreement on next steps

Priorities - 1 Received from many, agencies and offices –More to come Summary tables –Developed to include all items received –Reviewed at 06/05 interagency meeting –Revision in progress

Priorities - 2 Sorted according to goals of 1994 Plan –Develop new and improved vaccines –Ensure safety and effectiveness –Better educate public and health professionals –Achieve better use of existing vaccines Further sorted to Areas and Issues –E.g., Manufacture and Supply Surge capacity/rapid response Oversight Domestic Capacity Stability of vaccine supply

Priorities - 3 For planning purposes –Lead agency/agencies E.g., FDA –Contributing agencies E.g., CDC

Next Steps -- Priorities Lead, contributing agencies, NVPO –Identify/develop actions for each issue –2010 milestones –2020 milestones? Draft discussion document –Establish Task Force to do this

Stakeholder Involvement: Current Thoughts on Approach Complete priorities’ table with introduction and annotation National Vaccine Advisory Committee review and comments Engage other expert stakeholders – process of engagement being determined Engage broader groups of stakeholders, including the general public

Stakeholder Involvement: Next Steps NVPO develops draft priorities document for interagency review and comment NVAC review of document Implementation of stakeholder engagement

Further Comments NVPO (Drs. Gellin, Tardif) NVAC (Dr. Hinman) Interagency group participants NVAC discussion