H1N1 COUNTERMEASURES STRATEGY AND ... - PHE Home

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NBSB Pandemic Influenza Working Group Detailed Report Federal Advisory Committees: NVAC—Gus Birkhead, M.D., M.P.H. Dr. Birkhead explained that NVAC’s responsibility is laid out in statute and covers everything from research through funding. He detailed some of NVAC’s recent accomplishments, most notably the initiation of a review of the entire Federal vaccine safety system, including mechanisms for monitoring H1N1. NVAC believes its role in addressing H1N1 is to focus on implementation of vaccine programs by acting as a conduit for stakeholder input, helping with coordination among the other Federal advisory groups, and focusing on vaccine safety. It will hold monthly teleconferences throughout the summary to get updates from Federal and other partners on planning and implementation. NVAC is working with NVPO and the CDC Immunization Safety Office on its vaccine safety assessment. At its meeting earlier in June, NVAC reached consensus on several issues related to H1N1: Accelerate the urgency of planning efforts, because State and local planning efforts are already behind. Public health providers need more resources: o State and local health departments lost 10,000 workers last year and expect similar staff cuts this year. o The pandemic response will be simultaneous and require tracking, treatment, and addressing the concerns of the “worried well,” but pandemic influenza funding for State and local health departments ended in 2008, and other preparedness funding has declined. o While Congress has proposed $350 million in supplemental funding for pandemic influenza response, conservative estimates of the cost of simply administering vaccine are far higher. (At $15 per dose for administration, the total would $9 billion.) Vaccine safety is critical. Implementation considerations include the need to involve State and local public health providers in planning assumptions, such as prioritization of target populations. States need to define their role in actual distribution vs. central distributions, and they will need more resources if they are to distribute 15,000 packets per day. Implementation plans should take into account additional clinic procedures if a vaccine is used under an EUA (forms, signatures, counseling, questions), as well as requirements for accounting and measurement. Communication strategies should include risk communication that conveys the risks and benefits; strategies should also be flexible enough to facilitate communication of new risks as they are identified. Adverse event monitoring also should be considered. Dr. Birkhead said VSD is the key database for determining causal associations between adverse events and vaccination, but it may be of limited use because exposure information will be lacking if vaccine is not administered by health care providers and billed through one of the eight participating managed care organizations. One approach would be to link VSD with public health databases. VSD may also be hampered by the 46
NBSB Pandemic Influenza Working Group Detailed Report use of products from up to five different manufacturers, plus seasonal vaccine. Active surveillance is needed, especially for high-priority groups. Discussion Dr. Pavia: We probably have a vaccine, and we think we want to use it. So, we need to identify the target groups, priorities, doses, how it will be administered, contraindications, coadministration with seasonal vaccine, etc. I want to hear from the other Federal advisory groups: What information do you need to make a decision? Do you have that information? How can we inform the decision process? Dr. Neuzil: At ACIP, we’re 15 members, selected for our diverse expertise and representation, and we make recommendations to the director of CDC and to the HHS Assistant Secretary for Health. Our charter addresses vaccine licensed for the civilian population and maybe also for vaccines that are not yet licensed. So that’s why it’s important to understand if the H1N1 vaccine will be licensed or not. Under what circumstances does ACIP make decisions on unlicensed vaccines? Who decides what we should address? It’s in our charge to make recommendations on current seasonal vaccine, and we have. Nothing that I’ve heard so far would make me reassess our recommendation for the 2009–2010 seasonal vaccine. It’s important to understand that despite logistical and communication challenges of coadministration or sequential vaccine, nothing makes me think that the benefit for seasonal vaccine is not there. Dr. Pavia: Have we set a goal? Reduce the number of deaths? Minimize disruption? Who sets that goal? CAPT Fiore: The overarching goal so far has been to reduce deaths, hospitalization, and complications of seasonal influenza, and I expect the goal will be the same for pandemic influenza. We have relatively few deaths now, so we may need to reassess and look at severe illness and hospitalization or societal disruption. I think ACIP would contribute to goal-setting. Also, as influenza vaccination progresses, we’ve expanded the groups for whom we recommend vaccines greatly in the past 10 years; now, 84% of people are affected by annual influenza vaccine recommendations. ACIP goes beyond listed indications, e.g., recommending that pregnant women get influenza vaccine. It is an unusual Federal advisory group. It has ongoing work groups that meet throughout the year, including one on H1N1. The groups have other liaisons and ad hoc experts. ACIP has made decisions despite gaps in data by relying on expertise, and the group is comfortable talking in public forum about its concerns. Dr. Schonberger: Who deals with questions related to what’s available when? If you treated the new pandemic virus-related antigen like regular seasonal vaccine—15 mcg, no adjuvant, injected—and used it under an EUA, that could be ready quickly (without doing formal, time-consuming, clinical trials). But the lines that the manufacturers are pursuing mean there will be delays. Who evaluates that issue? If we decide to do clinical trials on adjuvants, that’s a decision that leads to a later vaccine. Dr. Pavia: If we leave aside the question of adjuvants, I’m uncomfortable making a decision about using one dose for all. We need at least some dose-response studies. 47
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