[an error occurred while processing this directive]
National Vaccine Advisory Committee – Workgroups
A number of working groups have been convened to address specific items from the activities of both the full Committee and its subcommittees.
The charge to the Vaccine Safety Working Group is to-
- Undertake and coordinate a scientific review of the draft Immunization Safety Office (ISO) research agenda. Advise on:
- Content of ISO draft research agenda (e.g., are the topics on the agenda appropriate? Should other topics be included?)
- Prioritization of research topics
- Possible scientific barriers to implementing the research agenda and suggestions for addressing them
- 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.
Previously, the Working Group held a stakeholders meeting and prepared a report responding to a request made by the Institute of Medicine (IOM) in its report entitled "Financing Vaccines in the 21st Century: Assuring Access and Availability." As a result of these deliberations, the Committee developed a set of recommendations, submitted to the Department in December 2004, addressing the approaches that they feel should be taken to stabilize the financing of immunizations in the United States. Issues concerning the financing of vaccines are being considered by the Subcommittee on Immunization Coverage.
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 is to develop a series of recommendations for the programmatic and financial implementation of adolescent immunization recommendations. This will 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.
Updated information about this working group will be available shortly.
- H1N1 Vaccine Safety Risk Assessment:
The H1N1 Vaccine Safety Risk Assessment
Working Group (VSRAWG) will conduct rapid reviews of 2009 H1N1 vaccine safety
data and provide ongoing updates of their findings to the NVAC. The VSRAWG
held an initial in-person meeting in November 2009 and will meet regularly
to review and assess data for six months after the conclusion of the 2009
H1N1 influenza vaccination program. The VSRAWG will make monthly reports
to the NVAC.
Following the February 2005 meeting, a joint NVAC/Vaccines and Related Biological Products Advisory Committee (VRBPAC) working group has been 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 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)
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 will be published in Clinical Infectious Diseases in the near future. An NVAC report, "Strengthening the Supply of Routinely Recommended Vaccines in the United States," is posted on the NVPO Web Site at http://www.hhs.gov/nvpo/bulletins/nvac-vsr.pdf.
Issues of vaccine supply are now being considered by the Subcommittee on Vaccine Development and Supply.
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. Ongoing activities include 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: http://www.hhs.gov/nvpo/nvac/oct04.html.
Issues regarding public participation are now being 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: http://www.hhs.gov/nvpo/nvac/oct04.html.
Polio Laboratory Containment:
The National Vaccine Advisory Committee 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.
Specific actions include:
- Review the National Plan of Action and protocol/description of inventory process.
- Ensure that the National Inventory database of laboratories is complete and that all relevant biomedical laboratories have been targeted.
- Review data collection procedures to ensure that reports were obtained from appropriate individuals within institutions.
- Affirm that information has been accurately recorded in the interim National Inventory database.
- Recommend that NVAC (as the National Certification Committee) endorse the HHS submission of the interim National Inventory to the American Regional Certification Commission.
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. Specific actions include:
- Review expanded National Plan of Action for containment.
- Review mechanism for notifying the laboratory community that wild polio circulation has been interrupted.
- Ensure that all agencies retaining or likely to retain wild poliovirus materials have been contacted and have provided adequate documentation BSL containment as appropriate.
- Ensure that the final National Inventory report is complete and accurate.
- Recommend that NVAC (as the National Certification Committee) endorse the HHS documentation of containment for submission to the American Regional Certification Commission.
Challenges identified by the Workgroup
- Ensuring that institutions/laboratories are aware that inventory and containment is a two phase process.
- Defining Workgroup action priorities for Phase I and II tasks.
- Identifying appropriate mechanisms to validate the completeness of laboratories on the database.
- Recording institution reports of destruction of wild poliovirus materials.
- Developing a system to ensure that new labs are included on the inventory as appropriate.
- Investigating the feasibility of conducting site visits.
- Categorizing laboratories to be contacted when Phase II begins.
- Approaches to dealing with non-responding laboratories.
- Scheduling annual letters to laboratories listed on the inventory to keep them informed.
- Ensuring that the reporting process for academic institutions incorporates replies from all levels of the institution.
- Reviewing the potential for designating poliovirus as a select agent in the post eradication period.
- Assuring that the interim HHS report endorsed by the Workgroup is accurate for all relevant US biomedical laboratories.
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." A copy of the report can be found at: http://www.hhs.gov/nvpo/polio/.
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 is currently being 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 will be 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/nvac/reports.html.