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Implementation of ACIP Recommendations

Implementation of the Initial Target Group Recommendations

To facilitate vaccine administration to those at highest risk for illness and complications, CDC’s ACIP recommended an initial set of target groups for vaccination (Box 4-1). ACIP also developed a subset of target groups for use during times of limited vaccine supply. The specific implementation strategy for these recommendations was left to state and local jurisdictions.

Because initial vaccine supplies were low, most state and local public health departments, including all of those represented at the workshops, requested that vaccine be given first to members of the initial target groups. However, within this broad approach, jurisdictions had many decisions to make. For example, jurisdictions had to decide whether to focus initially on reaching all members of the initial target groups or whether to first focus on the subset of target groups. Practical considerations, such as the availability of particular formulations, impacted the order in which groups and subgroups were vaccinated. Jurisdictions and healthcare providers also had to decide how rigidly to enforce the recommendations.



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4 Implementation of ACIP Recommendations Implementation of the Initial Target Group Recommendations To facilitate vaccine administration to those at highest risk for illness and complications, CDC’s ACIP recommended an initial set of target groups for vaccination (Box 4-1). ACIP also developed a subset of target groups for use during times of limited vaccine supply. The specific im- plementation strategy for these recommendations was left to state and local jurisdictions. Because initial vaccine supplies were low, most state and local pub- lic health departments, including all of those represented at the work- shops, requested that vaccine be given first to members of the initial target groups. However, within this broad approach, jurisdictions had many decisions to make. For example, jurisdictions had to decide whether to focus initially on reaching all members of the initial target groups or whether to first focus on the subset of target groups. Practical considerations, such as the availability of particular formulations, im- pacted the order in which groups and subgroups were vaccinated. Juris- dictions and healthcare providers also had to decide how rigidly to enforce the recommendations. 25

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26 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN BOX 4-1 Advisory Committee on Immunization Practices (ACIP) Recommendations Initial Target Groups (estimated 159 million Americans) (CDC/ACIP, 2009) ACIP recommended that initial vaccination efforts focus on persons in the following five target groups (order does not indicate priority): • Pregnant women, • Persons who live with or provide care for infants younger than age 6 months (e.g., parents, siblings, and daycare providers), • Healthcare and emergency medical services personnel, • Persons ages 6 months to 24 years, and • Persons ages 25 to 64 years who have medical conditions that put them at risk for influenza-related complications. Subset Target Groups (estimated 42 million Americans) ACIP recommended that the following subset of the initial target groups receive priority for vaccination if supply of the vaccine initially available was not adequate to meet demand for vaccination among the five target groups listed above (order does not indicate priority): • Pregnant women, • Persons who live with or provide care for infants younger than age 6 months (e.g., parents, siblings, and daycare providers), • Healthcare and emergency medical services personnel who have di- rect contact with patients or infectious materials, • Children ages 6 months to 4 years, and • Children and adolescents ages 5 to 18 years who have medical condi- tions that put them at risk for influenza-related complications. Prioritizing Within Initial Target Groups ACIP provided both an initial set of target groups and a subset of those groups; jurisdictions were free to decide whether to focus initially on the broader set or on the subset. However, Utah’s deputy director for public health practice, Teresa Garrett, said, “We were almost forced into moving to the subgroups just because of what we had—not necessarily because of what we wanted to do and where we wanted to go first, but because of what was physically in our possession.” The first deliveries of vaccine to many places were LAIV nasal spray formulations that were contraindicated for many members of the target groups. Because of this practical consideration, in many jurisdictions initial efforts focused pri- marily on healthcare workers and pediatric patients without contraindica-

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27 IMPLEMENTATION OF ACIP RECOMMENDATIONS tions for LAIV. The issues surrounding vaccine formulations and LAIV are discussed in more detail below. In LA County, the decision was made to use ACIP recommendations for the larger initial target groups and to not explicitly use the subset of target groups. Instead, however, messaging, images, and media were used to target members of subset groups such as pregnant women and adults with chronic conditions, though no one was turned away at the clinics when vaccine was available. Many state and local public health authorities operationalized the implementation of ACIP recommendations by distributing vaccine to partners that already provided care to targeted populations. For example, many states preferentially filled vaccine orders for pediatricians and OB/GYNs. In Chicago, vaccine was given to clinics that served the tar- geted populations. Workshop participants also discussed how decisions were made when not enough vaccine was available to cover all members of groups or subgroups indicated for the formulation of vaccine available. For ex- ample, would the LAIV dose be given to a healthcare worker or to a 12- year-old without contraindications? Some jurisdictions left the decisions up to healthcare providers, positing that they were the ones who knew their populations best. Cathy Slemp, acting state health officer and direc- tor of the Division of Threat Preparedness for the Bureau of Public Health in the West Virginia Department of Health and Human Re- sources, noted that West Virginia empowered private clinicians to use their best judgment in terms of priority groups. Most importantly, physi- cians had to use the vaccine and not let it sit on shelves. “Our duty, our ethical obligation, was to provide vaccine to the highest-risk individuals, and so we tailored our policies to reflect that,” said Kristen Ehresmann, director of the Infectious Disease Epidemiol- ogy, Prevention, and Control Division of the Minnesota Department of Health and a member of ACIP. As far as how to make determinations within the target groups, Ehresmann explained that Minnesota had previ- ously done work with an ethics committee on the question of resource allocation in times of scarcity. The committee discussed the fact that at some point, random selection techniques would need to be employed— something that Minnesota did use when vaccine supplies were low. Al- though there may be many contributing factors, Ehresmann cited cover- age data as support for the use of random selection technique: Minnesota had the highest rate in the nation for vaccination for persons ages 25−64 with underlying risk conditions (CDC, 2010a).

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28 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN Enforcement of ACIP Target Group Policies Some jurisdictions and organizations followed the ACIP recommen- dations as strict guidelines, and others were more fluid in their approach. David Grossman, medical director for preventive care and senior investi- gator at Group Health Cooperative, a large healthcare system in the Seat- tle area, pointed out the difficulty for healthcare providers to impose any sort of limits. Group Health found it useful to refer to the ACIP recom- mendations when restriction of vaccine was necessary. Alonzo Plough, director of the Emergency Preparedness and Response Program of LA County, also appreciated the recommendations as a foundation, giving him the ability to point and say, “CDC is making us do this.” Other jurisdictions, such as Chicago, took a different approach, fo- cusing on the recommended target groups but not turning anyone away who showed up at mass vaccination clinics. Herminia Palacio, director of Harris County Public Health and Environmental Services in the Houston, Texas, area, explained that they worried that if they were too strict with the recommendations, they would be left with unused vaccine—a lesson learned from the seasonal vaccination campaign in 2004, when restrictive guidelines aimed at dealing with vaccine shortage eventually resulted in substantial surpluses. Lauren Smith, medical director of the Massachusetts Department of Public Health, agreed. She discussed the struggle between wanting to respond to the prioritization and not wanting to miss the chance to vacci- nate people who were on-site and waiting and might miss a call back when vaccine became more widely available. “The idea of balancing the restrictiveness to try and meet the guidelines with the idea that maybe you let some other people come along for the ride. If, ultimately, you are going to get more people vaccinated overall—who knows? You might actually get more people in your target groups vaccinated if you are less restrictive,” she suggested. First Responders The use of the ACIP target groups as the focus for initial vaccine ef- forts was a change from prior pandemic preparedness planning, which provided for immunization of first responders and critical infrastructure personnel in the first tier of vaccinations. The change was made because 2009 H1N1 had different characteristics from the H5N1 strain on which

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29 IMPLEMENTATION OF ACIP RECOMMENDATIONS plans had been based. Workshop participants noted that it is difficult to change the eligible population after publicly stating and training for a particular program. For example, one challenge was educating groups such as law enforcement about the new recommendations and why the scope was changed. Communicating the rationale for putting some peo- ple in target groups and not others was sometimes difficult. Smith of the Massachusetts Department of Health noted that in her state, the defini- tion of healthcare providers did not include all first responders, which caused challenges for the state. Some workshop participants also noted that they heard concerns from teachers and daycare providers that they were not in the priority groups, even though they had close and constant contact with children— one of the priority groups recommended to receive vaccine. Older Adults The 2009 H1N1 influenza virus did not affect the same patient popu- lation as typically seen during seasonal influenza outbreaks—older adults. Instead, it seemed to affect predominantly younger people. Work- shop participants noted that older adults are a major constituency for the seasonal influenza vaccine and were alienated when they were excluded early in the campaign. Although participants said this factor should not change the way priority groups are formed, several noted that public health authorities should be aware of the impact of excluding older adults in vaccine campaigns and should consider this when developing commu- nications strategies. This was a particular concern in tribal areas, where the exclusion of tribal elders was believed to have reduced vaccination rates among American Indians for whom vaccination was recommended because eld- ers are highly respected role models and messengers in their communi- ties. Finkbonner of the Northwest Portland Area Indian Health Board said giving tribal clinics flexibility to vaccinate elders in the future would im- prove vaccination rates throughout tribal communities. Expanding to the General Public Although the exact timing differed across the nation, workshop par- ticipants reported that most jurisdictions waited until December to open

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30 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN up vaccination to all members of the public. In many cases, jurisdictions waited until they had sufficient vaccine to cover their plans for vaccinat- ing target groups. For example, Alabama waited until sufficient vaccine was received to begin vaccination of children in schools. Once that was done, the state began shipping vaccine to pharmacies and other stake- holders for general distribution. Grossman of Group Health noted that when public health authorities decided to offer vaccine to the general public, Group Health was con- flicted about whether to also offer vaccination to all its patients. He said Group Health did not believe it had exhausted all possible means to en- sure that their highest risk patients were vaccinated. He described how it wanted to continue to focus on members of the target groups for a little longer, using electronic records to identify those at highest risk and call- ing them again to encourage them to be vaccinated. However, he said that in the end, being a single organization restricting vaccine was too difficult when the surrounding community and public health authorities had distributed vaccine to the general public. One lesson learned during the 2009 H1N1 vaccination campaign was that making the decision to expand vaccination beyond the original prior- ity groups to the general public does not necessarily result in a significant rise in vaccine administration rates. Workshop participants discussed possible reasons. The public had been receiving messages indicating that vaccine was not available to the general public. By the time vaccine was open to the public, many potential recipients may have assumed it would never be available—the window of opportunity to reach them had closed. Also, if disease was not prevalent locally, or was not receiving the same media coverage that it previously had, the drive to find vaccine was less urgent. These behavioral aspects need to be considered in the future, noted Brian Johnson, public health preparedness coordinator for Lane County, Oregon. He suggested incorporating realistic thresholds in the planning process—triggers that signal when to move from concentrating solely on target groups to widening the net to reach those in the public who may not get vaccinated as time passes. Participants noted that the rate of vaccination among target group members will never be 100 per- cent, so looking closer at that timeline would be an important future re- sponse. “Anecdotally,” Johnson said, “it was probably 4 to 6 weeks where we really had people’s attention, and then after that they started to trickle off quickly—right about the time, ironically, that the vaccine be- came readily available.”

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31 IMPLEMENTATION OF ACIP RECOMMENDATIONS Flexibility and Consistency Two notions of flexibility were discussed with regard to the ACIP recommendations. First, participants discussed the flexibility afforded to state and local public health jurisdictions to determine their own vaccine distribution and administration plans. Second, participants discussed whether the recommendations should have been revised as additional epidemiological data became available. These are discussed below. Cross-Jurisdictional Flexibility and Consistency In general, public health officials at the workshops reported that they valued the flexibility in implementing ACIP recommendations, despite the associated challenges. State public health officials also valued the flexibility to implement their own distribution plans in accordance with existing infrastructure and state needs. However, variability across state and county lines also created challenges for state and local public health officials. Jurisdictions that decided to maintain consistency with neighboring jurisdictions were concerned that their approach was not optimized for their population; jurisdictions that pursued their own plans found it harder to communicate effectively to the public about why one county or state was vaccinating a certain subset of its population and why another was not. Communicating those differences was a huge challenge, especially when national media outlets carried stories across the nation. Not all jurisdictions, however, valued the flexibility provided in im- plementing ACIP recommendations. “I actually heard more frequently, particularly from states out west with high percentages of American Indian/Alaska Native populations, that they would have appreciated clearer recommendations from ACIP,” said Redd of the IHS Division of Epide- miology and Disease Prevention. Participants also noted that the flexibility might have been appropri- ate only because the pandemic was mild to moderate in severity. “If that had been a severe pandemic,” Minnesota’s Ehresmann said, “I really think the consequences of inconsistency would have been devastating.” Jeffrey Duchin, chief of the Communicable Disease and Immunizations Section of the Public Health–Seattle & King County, agreed, saying, “If it is a severe problem, we’re not going to look as kindly upon healthy, young adults getting vaccines when persons with underlying medical conditions aren’t getting it and are dying.”

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32 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN In contrast to many of the public health representatives at the work- shops, many of the representatives from multijurisdictional healthcare systems, large chain pharmacies, large companies with occupational health programs, and tribal authorities whose reservations crossed multi- ple state boundaries said that having different strategies in different ju- risdictions was problematic for them. “One of the biggest challenges we faced was the cross-jurisdictional interpretation of recommendations and decisions that were made to prioritize vaccine for specific populations,” said Grossman of Group Health. The company serves patients across multiple jurisdictions, each of which had its own plan. In one county, he said, children were the priority; in another, healthcare workers. “I think that we need to have one public health standard in this country, and it needs to be consistent across jurisdictional lines,” Grossman added. States and jurisdictions such as Minnesota and Washington, DC, also ran into challenges along border areas when neighboring jurisdictions had different policies. DC, for instance, is intimately tied to its surround- ing states, where many DC workers live. Beverly Pritchett, senior deputy director at the DC Department of Health, noted, “It is critical to keep pace with your immediate adjacent jurisdictions, particularly as they may impact you, but we probably needed to selectively consider how we would implement those on a varied basis.” In the case of DC, university students make up a sixth of the population, more than in surrounding states. The recommendations called for not vaccinating those over age 24, excluding many who attend graduate programs. Pritchett noted that DC public health officials wanted to use flexibility to vaccinate these students, but decided not to so they could be consistent with surrounding jurisdictions. Several participants suggested that further consideration about the appropriate balance between flexibility and standardization would be valuable. Flexibility to Revise Recommendations A few participants felt that there were problems with the ACIP rec- ommendations during the early vaccine shortage. “It became clear during the outbreak that actual mortality risk was greatest in individuals with underlying disease who were between 25 and 64 years old,” said Fleming from Seattle & King County. Although this group was included in the broader ACIP target groups, it was not included in the subset of target groups that was recommended if vaccine supplies were limited. Duchin,

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33 IMPLEMENTATION OF ACIP RECOMMENDATIONS also from Seattle & King County, said when the vaccination campaign started in October, ACIP members discussed whether to revise the rec- ommendations for the subset of target groups to include adults who had medical conditions that put them at higher risk for 2009 H1N1–related complications. However, he noted, the ACIP voting group decided not to make this change for several reasons. First, it believed that changing rec- ommendations during the campaign might cause confusion; second, it noted that local flexibility let healthcare providers vaccinate patients they believed to be at highest risk, including adults with relevant medical conditions; and third, at the time it believed that the shortage of vaccine supply would be brief and therefore that overprioritizing the vaccine would be counterproductive. Workshop participants discussed the difficulties that would be asso- ciated with changing target groups during an event, including the chal- lenge of communicating the change to the public, the difficulty of changing operational plans midcourse, and the overall potential for con- fusion. However, they also acknowledged that during the course of a pandemic, the epidemiology may change or data may become available that indicate that a revision to the prioritization plan is warranted. “The system needs to be nimble enough so that when data support a change to a recommendation, it can be made—and it needs to be uniform,” noted Ehresmann of Minnesota. Duchin suggested it would be valuable to re- view the prioritization decision-making process to identify any areas where potential improvements could be identified to help future prioriti- zation situations. Vaccine Formulations and Target Groups The variety of vaccine formulations from several manufacturers and the inability to predict the time frame over which the various formula- tions would be available and in what quantities were extremely challeng- ing for public health authorities and healthcare providers. 2009 H1N1 vaccine was produced by five manufacturers in four formulations (adult- dose prefilled syringes, pediatric-dose prefilled syringes, multidose vials, and prefilled single-dose intranasal sprayers), each with different age indications and labeling. Participants said it was particularly challenging when nearly all initial vaccine was live-attenuated vaccine, which was not indicated for many people in the target groups. Healthcare providers reported not being able to vaccinate their highest-risk patients until later

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34 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN in the campaign because they initially received primarily or only live- attenuated vaccine. This issue was more complicated for pediatric prac- tices, compared with vaccinating adults, because of the many age indica- tions among products. This complicated efforts to schedule patients for vaccinations and added challenges in communicating with parents about whether vaccine was available for their children. Acceptance of LAIV Many organizations that received LAIV in their first deliveries de- cided to offer the LAIV nasal spray to healthcare workers who were not contraindicated for this formulation. However, uptake of live-attenuated vaccine was low among eligible healthcare providers and the public, of- ten because of unfounded concerns about transmission to patients in healthcare settings and vaccine efficacy. “A lot of people had a lot of concerns,” said Salyer-Caldwell of Texas. “They desperately wanted some vaccine. They did not want the live virus [formulation],” despite education about the safety and efficacy of the vaccine. “We found early on that a crisis probably wasn’t a good time to explain to someone that a nasal vaccination was a safe and effective way to be vaccinated,” said J. Michael Muhm, associate technical fellow at The Boeing Company. By contrast, some pediatric practices that had used FluMist™ in the past had substantial uptake of LAIV. Those practices were strong pro- moters of the formulation, and their patients were already comfortable with the process. Texas pediatrician Terk noted that patients and parents responded to the comfort level and information capacity of their medical professional. If the practitioner was comfortable with LAIV and led by example, patients accepted it much more readily. Other jurisdictions were able to increase the uptake of LAIV by sys- tematizing its use. West Virginia did not have much success in vaccinat- ing healthcare workers with LAIV, so instead offered it to EMS workers, who often work with the targeted population groups. By Thanksgiving workers realized they would have a substantial LAIV surplus, so they offered it to college clinics. In Massachusetts there was an emphasis on providing LAIV to elementary and school-age populations, and it was given at school-based clinics. Positive feedback indicated that both pa- tients and healthcare providers found nasal administration easier than giving injections. In Wake County, NC, instructions were sent to all clin- ics that if someone was not contraindicated for LAIV, only LAIV should

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35 IMPLEMENTATION OF ACIP RECOMMENDATIONS be offered unless a patient insisted on a different formulation. This strat- egy was also used in other jurisdictions, with varying levels of success. Opportunities in Using Priority Groups Numerous individual suggestions were made for addressing chal- lenges related to using priority groups to help improve future emergency vaccination campaigns. These suggestions are compiled here as part of the factual summary of the workshops and should not be construed as reflecting consensus or endorsement by the workshops, the Preparedness Forum, or The National Academies. They are as follows: • Assess the optimal balance of flexibility and standardization (proscription) in the ACIP guidelines, including considera- tion of whether/how this balance should shift according to the characteristics of the situation. This would include assess- ing where flexibility is or is not warranted and considering proc- esses that could be used to begin to weed out unwarranted flexibility. • Review the prioritization decision-making process to identify any areas where potential improvements could be identified to help in future prioritization situations. This would include consideration about the impact of changing priority groups dur- ing a public health emergency. • Federal authorities and vaccine producers should ensure that the formulations and indications of the vaccine produced match the targeted groups to the greatest extent possible. • Where possible, harmonize age indications for comparable products (especially when licensed elsewhere) when there are multiple formulations with different age indications available. • Tribal clinics should have flexibility to vaccinate elders in fu- ture programs if they think it would improve vaccination rates throughout their communities. • Increase acceptance of live-attenuated nasal spray vaccine. Uptake of live-attenuated vaccine was low among eligible healthcare providers and the public, often because of unfounded concerns about transmission to patients in healthcare settings and vaccine efficacy.

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36 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN Engage the manufacturer to create public education o campaigns for LAIV. Educate healthcare providers and the public about the o safety of the nasal spray vaccine. Clinics and healthcare providers should consider (in a o shortage situation) how nasal spray vaccine will be given unless contraindicated. Refer to “nasal spray vaccine” instead of “live attenuated.” o