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NBSB Pandemic Influenza Working Group Detailed Report At present, FDA believes evidence is sufficient to recommend evaluating adjuvants in clinical trials and to consider for use under an EUA. Ultimately, use of adjuvants is a policy decision. FDA recognizes that a coordinated effort may be needed to help health care providers understand the options when faced with a variety of products. Dr. Sun pointed out that FDA does not have primary responsibility for liability concerns. In general, however, the Public Readiness and Emergency Preparedness (PREP) act provides liability protection and compensation mechanisms for products used under an EUA. Discussion Dr. Pavia: What would be the impact of adjuvants on attenuating disease in the fall? Also, what are the international implications if the U.S. uses one-tenth of the global vaccine supply? What are the ethical and legal implications of using a product that may carry a higher risk to the individual but is thought to better benefit society? Mr. Ferguson: The timing of the epidemic and the vaccination window are key. We expect to see it peak in October, so it’s a narrow window. What the U.S. uses affects the rest of the world, and there’s a meeting on that topic going on in Seattle right now. Gary Noble, M.D., M.P.H.: All these points have been made, but I think they bear reiterating: It’s best not to have the President out there as a spokesperson for vaccine policy. Let data drive decisions where you can. Keep the steps open to change. It is unlikely there will be enough clinical data for decision-making. There are arguments for using adjuvant to extend vaccine and possibly for dampening interference from seasonal vaccine, but there will be real or perceived side effects. If a rapid response is needed, chances are you won’t have data. Be prepared to address communication and public confidence—e.g., use some term other than “oil-in-water.” [Unidentified]: Other countries are thinking more about dose-sparing and adjuvants than we are. We had the experience of 1976 and clinical trials show that the priming will be there for many in our population. There are thoughts at WHO that the U.S. will use all the antigen because it will not use adjuvant, and the world needs dose-sparing. But the real issue is when the vaccine will be available. If clinical trials are finished after the event, it doesn’t matter, and evaluating the risks and benefits of a monovalent vaccine will not help. The important lesson of 1976 was that we must be flexible. Maybe we should be thinking about priming the rest of the population that was not primed by the first and second wave. We’re going to see lots of disease in fall. It’s going to be a tremendous job to explain why we’re giving seasonal vaccine that doesn’t protect against <strong>H1N1</strong> and then trying to give <strong>H1N1</strong> when seasonal influenza is peaking. Dr. Pavia: Dr. Robinson showed a model of a hybrid approach of using adjuvant for some people. 40
NBSB Pandemic Influenza Working Group Detailed Report Dr. Treanor: That sounds complicated, but it’s a good idea otherwise. Tailoring the vaccine for the target population sounds good, but implementation is a problem. We have trouble using vaccine in anything other than simple strategies. Robert Field, J.D., Ph.D., M.P.H.: Public health ethics differ from clinical bioethics. Mainly, public health is about populations—what’s good for large numbers—so it is the principle of utilitarianism. Clinical bioethics focus on autonomy, such as the doctorpatient relationship and the right to die. If we’re talking about protecting a population, utilitarian concerns come into play. If the goal is to protect the safety of the population, look at what gets the most vaccine out there. If the goal is to protect vulnerable populations, then more specific issues come into play. Keep in mind the importance of communication. Vaccine is such a hot topic, as we see with the focus on exemptions, autism, etc. Consider economic, social, and other effects if key people can’t function. Let your decision-making flow from your ultimate goals. Brooke Courtney, J.D., M.P.H.: Liability is always an issue, but there are strong legal tools and protections available, such as EUAs and the PREP act (as long as compensation funds have money). Liability is important, but we shouldn’t let liability be too large a concern with moving forward on these difficult decisions and paralyze our planning efforts. If there is mass vaccination, one thing we tend to overlook is that it will largely be coordinated at the State and local levels, which are already stretched to the max to provide daily services and otherwise respond to the pandemic. You may assume that if medical countermeasures are available, the public health system will easily and quickly be able to get them where they need to go, but that will be extraordinarily difficult, even with good planning; on top of mass vaccination, there are the issues of receiving and storing Strategic National Stockpile assets, use and allocation of antivirals, etc. Even though many health departments have significantly improved their response capabilities since 2001 and are very well prepared, these are very challenging issues, especially with the budget and staffing challenges that most health departments are currently facing. We need to consider how decisions about adjuvants might impact local public health providers. If the timing is right, a better vaccine using less antigen means more people could get vaccinated. Fewer people would potentially get sick, so the surge in health care could be lower. Having more vaccine available potentially could mitigate difficult vaccine allocation decisions at the local level. It’s hard to develop allocation plans on paper but even more difficult to implement them at the local provider levels. So, a shortage of vaccine means more challenging allocation issues at the local level. On the other hand, using adjuvant in a hybrid approach would seriously complicate local decision-making. There’s also the complexity of EUAs at the local level. If you go that route, be sure to get information out as early as possible to public health professionals and health care providers. If an EUA requires forms, such as instruction sheets to hand out to the public, that’s a big deal—even things that might seem simple, like the logistics of making copies, can be a big challenge for health departments. Whatever is decided, make sure State and local public health providers get clear, consistent, early guidance 41
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