Past Working Groups
The NVAC Vaccine Safety Working Group (VSWG) completed its first charge to review the CDC Immunization Safety Office’s Scientific Agenda in July of 2009. A detailed summary of Working Group activities and public engagement around to review the CDC Immunization Safety Office’s Scientific Agenda can be found here and the VSWG full report and recommendations can be found here. The second charge of the VSWG was “to review the current federal vaccine safety system and develop a White Paper describing the infrastructure needs for a federal vaccine safety system to fully characterize the safety profile of vaccines in a timely manner, reduce adverse events whenever possible, and maintain and improve public confidence in vaccine safety.” The White Paper on the U.S. Vaccine Safety System of the VSWG was reviewed and approved by NVAC. The White Paper, found here, was formally transmitted to the Assistant Secretary for Health, who reviewed and will consider them for potential implementation options.
In preparation for the 2009 H1N1 vaccine program, NVAC established the H1N1 Vaccine Safety Subgroup within the VSWG with the charge to review the current Federal plans for safety monitoring and provide feedback on the adequacy, strengths, weaknesses and considerations for enhancement. The draft recommendations, found here, were developed by the NVAC H1N1 Vaccine Safety Subgroup of the VSWG. They were subsequently reviewed, deliberated upon, and approved by the NVAC. The final recommendations were then formally transmitted to the Assistant Secretary for Health. All of these recommendations were implemented.
The H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG) conducted rapid reviews of 2009 H1N1 vaccine safety data and provided ongoing updates of their findings to the NVAC. The VSRAWG meet regularly to review and assess data from federal vaccine safety monitoring systems, described in Federal Plans to Monitor Immunization Safety for the Pandemic 2009 H1N1 Influenza Vaccination Program. The VSRAWG provided monthly reports to the NVAC on public conference calls and a final report at the February 7, 2012 NVAC meeting. Reports from the VSRAWG were deliberated and approved by the NVAC and formally transmitted to the Assistant Secretary for Health. All VSRAWG reports are available at NVAC’s Reports, Recommendations, and Resolutions page.
Adult Immunization Working Group
The NVAC convened an Adult Immunization Working Group (AIWG) in 2008. The first task of this working group was to assess public health adult immunization activities in HHS and other federal programs. This included identifying gaps and recommending improvements in program implementation, coordination, evaluation and collaboration across agencies to improve vaccination uptake in adults. The AIWG made recommendations in 9 areas to improve the function of federal programs to support adult immunization. The recommendations were approved by the NVAC in June 2009.
The AIWG completed its second charge, to develop recommendations for a comprehensive, sustainable, national adult immunization program that will lead to vaccine preventable disease reduction by improving adult immunization coverage levels. The recommendations were approved by NVAC in June 2011. The full report is available at the journal Public Health Reports.
Health Care Personnel Influenza Vaccination Subgroup
The Adult Immunization Working Group (AIWG) of the National Vaccine Advisory Committee established the Health Care Personnel Influenza Vaccination Subgroup in November 2010. Their charge was to develop recommendations on strategies to achieve the Healthy People 2020 annual goal of 90% influenza vaccine coverage for health care personnel.
The public comments to the draft report of the Health Care Personnel Influenza Vaccination Subgroup of the National Vaccine Advisory Committee are available here. The final NVAC report is available here at the NVAC’s Reports, Recommendations, and Resolutions page.
In 2006, the National Vaccine Advisory Committee (NVAC) formed a Vaccine Financing Working Group (VFWG) to examine the current state of financing vaccinations for children and adolescents in the United States, to define any financial barriers to effective delivery of vaccines, and to explore policy options to address these barriers. As a result of their deliberations, a White Paper entitled ‘Assuring vaccinations of children and adolescent without financial barriers” was created and included the Working Group’s findings, conclusions and proposed recommendations and takes into account public comments and stakeholder feedback received.
The report with recommendations was presented to the full NVAC for consideration and adoption during the September 2008 NVAC meeting and was subsequently forwarded to the Assistant Secretary for Health for his review. Status updates on the implementation plan for these recommendations have been presented to NVAC during the February, June and September 2009 meetings.
- Assuring Vaccination of Children and Adolescents without Financial Barriers: Recommendations from the National Vaccine Advisory Committee (NVAC) - March 2009 [PDF - 469KB]
- Children and Adolescents Vaccine Financing Recommendations Adopted by NVAC - September 2008
- An implementation plan has been developed to track progress in instituting the recommendations.
- To date, Congress has allocated additional funding from the American Recovery and Reinvestment Act (ARRA) to support three of the recommendations (14, 19, 22). Additionally, NVAC and the National Vaccine Program Office (NVPO) continue to partner with the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services (CMS) to outreach to the appropriate stakeholders to adopt and implement these recommendations.
Following the February 2005 meeting, a joint NVAC/Vaccines and Related Biological Products Advisory Committee (VRBPAC) working group was established to examine potential legislative and regulatory changes that would be required to allow vaccines licensed for use in other industrialized countries to be licensed more expeditiously in the U.S.
The Working Group was developed by the Immunization Coverage Subcommittee following the June 2004 meeting: Strengthening the Delivery of New Vaccines to Adolescents: A National Stakeholders Meeting sponsored by the CDC and the NVPO. The charge to this working group was to develop a series of recommendations for the programmatic and financial implementation of adolescent immunization recommendations. This was to be accomplished by:
- Examination of available evidence regarding adolescent immunization programs
- Examination of available experience regarding adolescent immunization programs
- Determination of what additional information is needed.
The report with recommendations was presented to the full NVAC for consideration and adoption during the June 2008 NVAC meeting and was subsequently forwarded to the Assistant Secretary for Health for his review. Status updates on the implementation plan for these recommendations have been presented to NVAC during the September 2008 and September 2009 meetings.
- The Promise and Challenge of Adolescent Immunization as published in the American Journal of Preventive Medicine (Am J Prev Med. 2008 Aug;35(2):152-7)
- Adolescent Vaccination: Recommendations from the National Vaccine Advisory Committee, Adolescent Working Group - June 2008 [PDF - 842KB].
- An implementation plan has been developed to track progress in instituting the recommendations.
The Pandemic Influenza Working Group was formed following the June 2004 meeting to assist the Committee in the development of comments and recommendations regarding the draft HHS Pandemic Influenza Preparedness and Response Plan. The Committee's comments and recommendations were submitted to the Department in December 2004. The Working Group re-convened in April and June 2005 to provide guidance to the Department regarding the identification of priority groups for vaccination and antiviral administration and the purchase and distribution of vaccines. A second set of recommendations covering the use of vaccine and antiviral medications as well as the purchase and distribution of vaccine during a pandemic event. (http://www.hhs.gov/nvpo/nvac/documents/chairletter.pdf)
Polio Laboratory Containment
The National Vaccine Advisory Committee in 2004 convened a workgroup on laboratory containment of wild polioviruses to monitor implementation of the project.
Phase I — To assess the quality and completeness of the interim National Inventory and request additional information as necessary to satisfy that all Phase I requirements have been met.
Phase II — Review and recommend that NVAC endorse routine reports and documentation submitted by HHS upon request of the Regional Certification Commission (RCC). Review and recommend that NVAC affirm that the HHS submission of the final US National Inventory and containment documentation meet all RCC requirements for Global Certification.
The Working Group issued a report, which was accepted by the NVAC and entitled "Laboratory Containment on Wild Poliovirus in the United States, Phase I, The National Inventory of Institutions/Laboratories Retaining Wild Poliovirus Materials."
Enhancing Public Participation in Vaccine Policy Deliberations
The Working Group held a two-day meeting in September 2004 to discuss ways to consider options for enhancing public participation in vaccine policy deliberations and to evaluate a proposal from the Wingspread Public Engagement Planning Group for the Vaccine Policy Analysis Collaborative demonstration project. NVAC submitted recommendations to the Department in December 2004. Activities included support of public engagement activities around vaccine priority groups for pandemic influenza and plans for dialogs on adolescent vaccines. The Committee's recommendations can be found at this NVAC web site. Issues regarding public participation were then considered by the Subcommittee on Public Engagement and Communications.
This Working Group was formed following the February 2004 NVAC meeting to identify high priority issues and develop recommendations for improvement of the national influenza program. A preliminary report was submitted to the Department in December 2004. A copy of the report can be found at this NVAC web site.
The work group convened a Workshop on Strengthening the Supply of Vaccines in the United States in February 2000. The purpose of the Workshop was to review the status of vaccine supply in the United States and recommend ways to ensure a stable supply of vaccines. A report of the meeting was prepared, presented to NVAC, and approved by the Committee. Proceedings from the Workshop were published in Clinical Infectious Diseases. An NVAC report, "Strengthening the Supply of Routinely Recommended Vaccines in the United States," is posted on the NVPO Reports page NVAC Report: Strengthening the Supply of Vaccines in the U.S. January 2003 [PDF - 112KB] Issues of vaccine supply were subsequently considered by the Subcommittee on Vaccine Development and Supply.
Public Health Options for Implementing Immunization Recommendations
The Workgroup convened three "town hall" type meetings to discuss options for implementing immunization recommendations at the state level. A draft report was discussed among workgroup members and a framework for state decision making, which could be utilized by state authorities in the implementation of vaccine recommendations, has been developed. A report was submitted to the Department upon its completion.
Oral Polio Vaccine (OPV) Stockpile
The charge to the Joint Advisory Committee on Immunization Practices (ACIP)/NVAC Workgroup on OPV Stockpile is to:
- Develop the rationale for use of OPV to control an outbreak of poliomyelitis in the United States. Identify what, if any, the role of Inactivated Polio Vaccine (IPV) should be in an outbreak. Weigh the relative risks and benefits of the use of OPV vs. IPV in an outbreak and justify the use of OPV based on the risk analysis. Identify the outbreak criteria that need to be met to use OPV from the stockpile and to maximize the benefit: risk ratio. Is there a place to encourage development of a live attenuated poliovirus vaccine with an improved safety profile?
- Determine what the optimal characteristics of the OPV stockpile should be. Optimal characteristics of a stockpile may include specifying: the composition of OPV (e.g. trivalent or monovalent vaccine as discussed in WHO documents), the OPV characteristics (e.g., immunogenicity, efficacy, stability, shelf-life and potency), the experience with a particular OPV product (e.g., vaccine associated paralytic poliomyelitis), the quantity of OPV necessary to stockpile, the steps and process by which stockpiled vaccine will be made available rapidly (e.g. staged readiness, storage at multiple sites vs. single site), the option for rotation of OPV into market, and potential sources OPV (e.g., sole source versus multiple manufacturers)
- Identify incentives for manufacturers to supply OPV for a stockpile and for use in the event of an outbreak of poliomyelitis in the US. According to recent WHO estimates, OPV will be used on the world market at least until 2011. Nevertheless, in the next 7 years countries may increasingly prefer IPV or transition to exclusive use of IPV, thereby decreasing the world market for OPV and the incentive for manufacturers to stay in the market.
- Address potential FDA issues regarding consent, labeling, and release of an OPV manufactured outside of the US to control an outbreak of poliomyelitis in the US. It is unlikely that an OPV product will be licensed for use in the US. OPV therefore will likely be made available as an Investigational New Drug (IND) after obtaining approval by the FDA. The process of approval may involve complexities including, e.g., FDA evaluation of the production facility and IRB approval of the research protocol. Recipients of OPV will be informed that taking the vaccine constitutes participation in research. Asking for consent for participation in research and the known risk of Vaccine Associated Paralytic Poliomyelitis associated with OPV pose unique challenges to the consent process during an outbreak. Collecting the data required for research may be onerous and a disincentive during an outbreak control program.
The Working Group submitted a report and recommendations to the Department regarding the inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) stockpiles and overcoming special OPV stockpile challenges. A copy of the Working Group's report can be found at: http://www.hhs.gov/nvpo/reports/.