Lhds Flu Vaccine Production

Universal Influenza Vaccination Recommendations: Local Health Department Perspectives Geoffrey R. Swain and James Ransom rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr

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odern vaccines—including influenza vaccine—provide a uniquely powerful and cost-effective way to prevent deadly communicable diseases from spreading. Unfortunately, since the last decade of the 20th century, influenza vaccine supply and distribution problems have steadily grown worse in the United States. Supply disruptions such as delayed deliveries or shortages have occurred in 5 of the last 6 years, hindering efforts to combat a disease that every year kills about 36,000 people and sends more than 200,000 to hospital. Universal influenza recommendations may be one means of resolving our nation’s recurring influenza vaccine supply and distribution crises.

KEY WORDS: influenza, local health departments, universal

vaccination, vaccine distribution, vaccine supply

During the influenza vaccine shortage of 2004–2005, local, state, and federal governmental public health agencies and vaccine manufacturers collaborated in an unprecedented effort to share vaccine distribution information.1–3 This effort was an important step, but we need to go further. As a nation, we should move toward a clear recommendation for an annual influenza vaccination for everyone aged 6 months and older. Universal influenza vaccination would decrease the number and severity of influenza cases, save lives, and lessen the impact of influenza on the healthcare system and economy.4 By increasing demand, universal vaccination would be expected to build production and distribution capacity. Universal vaccination would not end the vagaries of vaccine strain production based on egg-based technology because there are many variables in this equation (eg, production, manufacturing, distribution, administration of vaccines, market forces).5–7 However, it is essential that we address each variable and make every J Public Health Management Practice, 2006, 12(4), 317–320  C 2006 Lippincott Williams & Wilkins, Inc.

effort to get to the point where the promise of influenza vaccine can be made good on in interpandemic periods, and where we could vaccinate everyone, quickly, in the event of an influenza pandemic. If well accepted, a universal vaccination recommendation would provide more stability for vaccine manufacturers, thereby significantly reducing annual fluctuations in demand on the basis of how many cases of influenza-like illness appear early in the season. This stability for manufacturers would likely result in both higher and more stable supplies of vaccine, which would in turn minimize the confusion of yearly, and sometimes mid-season, changes in recommendations that public health leaders must make because supplies are currently so difficult to predict. Additional benefits would result from the extensive public education that will be needed to achieve universal vaccination. People will better understand how vaccines work and why protecting themselves with annual influenza shots will also help protect people to whom they might unintentionally transmit the virus—their families, friends, clients, and coworkers. Our current system produces mixed messages— encouraging everyone to get an annual influenza shot, but having complex risk-based recommendations that shift with supply forecasts. This article will discuss perspectives of local health departments (LHDs), since perspectives of private practitioners have been discussed and detailed elsewhere.8 Minimizing future influenza vaccine supply disruptions—both for interpandemic influenza and for pandemic preparedness—is crucial to public Corresponding author: James Ransom, MPH, National Association of County and City Health Officials, 1100 17th St NW, Second Floor, Washington, DC 20036 (e-mail: [email protected]).

qqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqqq Geoffrey R. Swain, MD, MPH, Associate Medical Director, City of Milwaukee Health Department, and Center Scientist, Center for Urban Population Health, Milwaukee, Wisconsin; and Associate Professor, Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. James Ransom, MPH, Senior Analyst, Immunization Project, National Association of County and City Health Officials, Washington, DC.

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318 ❘ Journal of Public Health Management and Practice health’s mission. However, the manufacturing and distribution of influenza vaccine is controlled by the private sector. Even though the public sector accounts for a best-guess estimate of 15 percent of all doses purchased and administered,9 local public health is expected to be responsible for local mass vaccination in the event of a pandemic. At the same time, local public health has no solid support from state and federal agencies for assuring adequate vaccine supply. In addition, the nation does not have adequate public sector infrastructure for adult immunizations, and this gap cripples LHDs’ efforts to develop organizational capacity and infrastructure to vaccinate hard-to-reach high-priority adults and their contacts annually. This differs tremendously from the childhood vaccination platform, where governmental public health purchases a bulk quantity of those childhood doses through the vaccines for children (VFC) program.∗

● Local Public Health Department Perspective The National Association of County and City Health Officials (NACCHO) surveys LHDs every influenza season. Collectively, LHDs are not satisfied with federal efforts toward addressing the chronic influenza vaccine supply crises.10,11 Understanding the reasons for frustrations at the local level is fundamental to planning an effective strategy toward implementing universal recommendations. Many LHDs are concerned that the federal government and vaccine manufacturers are failing to keep a close eye on the threat from continued influenza vaccine supply disruptions. In response to years of influenza vaccine supply disruptions, many communities have developed their own reallocation and sharing schemes to better redistribute scarce doses of vaccine.12 The successes of these activities have resulted from strategic community partnerships formed between LHDs, private healthcare providers, nursing homes and other long-term-care facilities, hospitals, community health centers, pharmacies, and other entities that provide immunization services to the community. However, LHDs facilitate vaccine reallocation among these providers using 20th-century tools. They determine who has how many doses of vaccine by making phone calls and they record the results on simple spreadsheets. Eventually, in the event of an influenza pandemic, we will need a safe, sturdy, and reliable 21st-century system to confront it.

Routine use of state electronic vaccination databases would be a natural starting point to include adult immunizations. Regarding emergency preparedness in general, LHDs are an increasingly important part of our national security and readiness interests. But to the extent that public health preparedness includes the ability to deploy either preexposure or postexposure mass vaccination, the end result is that the linchpin of our readiness is in the hands of private companies, whose primary mission is not to protect the public’s health but to improve shareholder value. It is imperative to take every opportunity to solidify supplies and improve distribution channels of influenza and other life-saving vaccines. This may take a multipronged approach that could include increased public-private partnerships, targeted governemental regulation, secondary vaccine markets, federal purchase of additional doses, and last—not the least—increasing demand through a universal recommendation for influenza vaccine.

● Case Study: Milwaukee Many LHDs have historically provided substantial direct service delivery of influenza vaccine administration. More recently, some of these LHDs, like the City of Milwaukee Health Department (MHD), have partnered with local mass vaccinators to provide most influenza vaccine in their communities. In Milwaukee, the MHD has partnered with the local Visiting Nurse Association (VNA), and the VNA holds a large number of public influenza vaccine clinics at multiple sites distributed throughout the area. The MHD helps assure that sites serving underserved populations are included in the VNA’s clinic schedule, and helps the VNA advertise its clinic dates, times, and locations. The MHD’s role in direct influenza vaccine administration has thus recently been limited to vaccine for high-priority homebound individuals (for whom MHD nurses make home visits to provide vaccine), and some influenza vaccine provision for individuals presenting to the MHD’s routine childhood immunization clinics. While the MHD has invested substantial energy and resources in preparedness issues in general and in pandemic preparedness specifically, it has not yet—as some other LHDs have done∗ —used annual influenza vaccine administration as a vehicle to test and exercise its pandemic-scale mass vaccination capabilities. ∗

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The VFC helps families by providing free vaccines to doctors who serve eligible children and is administered at the national level by the CDC through the National Immunization Program. The CDC contracts with vaccine manufacturers to buy vaccines at reduced rates.

The NACCHO Influenza Vaccine Reallocation Database is an online collection of voluntary vaccine reallocation plans to help public health agencies and their community partners share information on influenza vaccine supplies. This database is a collection of critical local contingency plans that can help direct other jurisdictions in their efforts to prepare for supply disruptions.

Universal Influenza Vaccination Recommendations

The move from being a mass provider of influenza vaccine to partnering with a community-based agency (VNA, in Milwaukee’s case) for provision of influenza vaccine was a local policy decision. A substantial change in recommendations regarding who should receive influenza vaccine (ie, a universal recommendation) would spur the MHD to review that policy decision. The MHD would need to discuss the advantages and disadvantages of wading back into the mass vaccinator role. The pros include potentially improved emergency preparedness; the cons include questions of whether government should take over what the private sector seems to be doing well, and questions of what services the MHD would not provide as a result of investing staff resources into substantially increased influenza vaccine administration. However, this does not argue against a universal recommendation. In fact, universal recommendation or not, optimal emergency preparedness as it relates to mass vaccination may require LHDs such as the MHD to strengthen their partnerships with private entities, community-based vaccinators such as the VNA, and others. The fundamental issue at the moment is supply: it does very little good for the MHD to be prepared, either alone or in partnership, to vaccinate the entire 600,000-person population of Milwaukee if the amount of vaccine supply available is nowhere near that required to do it. To the extent that a universal recommendation would stimulate increased production capacity and thus stabilize and optimize supply of influenza vaccine during interpandemic periods, capacity and supply would also be likely greater in the event of a pandemic. Thus, a universal recommendation— by increasing supply—would also support the MHD’s other preparedness efforts and partnerships to be more effective when needed.

● Benefits, Implementation Issues, and Other Options A universal recommendation for influenza vaccine cannot be quickly or easily implemented. Although influenza vaccination is quite cost-effective, finance and reimbursement questions would need to be worked out. Strengthened public-private partnerships would be needed to assure that adequate resources are available for vaccination. A great deal of public education would also be required. The general public would need to understand that the risk factors have not gone away; certain people would still be at greater risk of complications and/or death from influenza, and it would remain true that those highest-risk persons would still be first priority in the event of a vaccine shortage during interpandemic periods.

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However, if the general public can grasp the concepts stated above and simultaneously understand that each person is a potential influenza transmitter, and that the health of all of us, in this case, depends in large part on the health of each of us, then we will have made substantial strides in increasing and solidifying the demand for influenza vaccine, which will in turn provide manufacturers with what they need to increase and solidify the supply. There are some other alternatives to increase supply and improve distribution, some of which could be used either separately from or in conjunction with a universal recommendation. For example, the CDC could act as a vaccine distributor for state and local health departments, and for others in the private sector as well. In this scenario, the CDC could order a guaranteed number of vaccine doses from each available manufacturer, and LHDs and others would order vaccine from the CDC at a pooled price. In addition to providing stable demand to support a stable supply, if one manufacturer experienced difficulties in production, no LHD would be caught without vaccine, since the CDC would still have supply from the others. In effect, the CDC could function as the clearinghouse at the national level that LHDs frequently serve now locally. Furthermore, it may make sense to initiate demonstration projects in several geographic areas. Particularly for interpandemic influenza, it makes intuitive sense that higher levels of vaccine uptake will result in higher levels of “herd immunity,” and thus lower attack rates even among the unvaccinated. The data from Milwaukee two decades ago show this clearly to be true for measles attack rates and measles-mumps-rubella vaccine completion rates.13 Influenza might not behave in the same way; specific demonstration projects showing universal vaccination associated with lower influenza attack rates among the unvaccinated may help to provide the data needed to support a universal influenza vaccination recommendation—and its implementation—nationwide.

● Conclusions Universal influenza recommendations present new obstacles and new opportunities for overcoming dangerous limitations in our current influenza vaccine supply and distribution situation. These limitations, though admittedly not entirely or directly caused by low supply, have forced LHDs to experiment with novel ways to connect their communities with life-saving vaccine. However, reactive responses such as improvised rationing do not necessarily equate with effective planning. Future success will depend on their ability to have adequate and reliable supplies of influenza vaccine, and

320 ❘ Journal of Public Health Management and Practice increasing demand through a universal recommendation is one strategy toward that end. If LHDs are expected to be central and key figures in responding to a pandemic scenario, then the expansion of production of influenza vaccine doses may be one key to ensuring that the necessary supply and distribution capacity is built in over time. Universal recommendations could help governmental public health to transcend a crisis mode of functioning and to more effectively address long-term system problems and challenges. Such a monumental change may require increased and innovative public-private partnerships. It may even require re-imagining a public health service and public health practice on the basis of principles of vaccines as public utilities and not as commodities. It will certainly require collective responsibilities and full cooperation on the part of all the partners—including political partners—in deliberative planning, providing technical assistance, and, most important, the creation of an infrastructure and network of resource support to sustain it.

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