IOM report airs lessons of H1N1 vaccination campaign

Oct 29, 2010 (CIDRAP News) – A workshop summary released today by the Institute of Medicine (IOM) offers a wide range of observations and suggestions about what worked well and not so well during the pandemic H1N1 influenza vaccination campaign—a complex, months-long operation with a cast of thousands.

The report distills into about 100 pages the discussions at three public meetings earlier this year attended by vaccination campaign participants from across the nation. The participants included public health officials from all levels, healthcare provider groups, pharmacy and health insurer groups, journalists, and community organizations.

The document presents no consensus recommendations but simply offers many suggestions from the participants. Many, but not all, of the findings and observations were aired in the news media during the vaccination drive, which was launched when H1N1 vaccines became available in early October of 2009.

The report describes how the supply of and demand for vaccine were poorly matched throughout the campaign: Demand was high and the vaccine was scarce in the beginning, but a few weeks later the situation was reversed and the supply far exceeded demand, even though anyone who wanted a shot could get one.

The document also explores how states used a variety of different methods for distributing vaccine supplies, and how state and local public health agencies varied considerably in how strictly they followed the federal guidelines for who should be vaccinated early on.

In addition, the report tallies the many different kinds of providers and settings that were employed in the campaign, from schools and clinics to pharmacies and occupational health clinics. It also looks at vaccination uptake in high-risk groups, data collection and monitoring, communications and media, and funding and payment issues.

The official aims of the IOM workshops were to examine innovative efforts used to distribute and administer vaccine and how they may inform future efforts, look at how public health agencies and providers interpreted the federal guidelines for use of the vaccine, identify innovative partnerships that worked well, and discuss strategies used to collect, evaluate, and use data.

Vaccine supply issues
The groups chosen for priority vaccination by the Advisory Committee on Immunization Practices (ACIP) were estimated to include 159 million people. They included pregnant women, close contacts of infants younger than 6 months, healthcare and emergency medical services workers, people between 6 months and 24 years old, and adults between 25 and 64 with certain medical conditions. The ACIP also suggested a narrower group in case supplies ran short; this excluded healthy young people older than 4 years, and it dropped the 25- to 64-year-old group with medical conditions.

The report recounts how the trickle of vaccine doses that began reaching providers in early October was inadequate to meet the demand from the target groups and remained so for 2 months. Compounding the problem, most of the first doses were the nasal spray vaccine, which was contraindicated for many of those in the target groups: small children, those with conditions such as asthma, and pregnant women.

H1N1 cases peaked in October and early November and then began to drop, just as the vaccine supply started to improve, the report notes. By January of this year the demand for vaccine had declined to the point that many providers had a surplus.

State and local public health officials planned their pandemic vaccination programs in the summer of 2009, relying on optimistic supply projections from federal officials, the report notes. Local officials worried about a vaccine glut and made plans to move as much vaccine as quickly as possible, but then were faced with a trickle of doses. As a result, "large-scale changes were needed in planned distribution strategies."

Workshop participants observed that vaccine production actually met the goals laid out in the national pandemic flu plan of 2006, in that the vaccine was widely available by December, 6 months after the pandemic was declared. Nevertheless, participants said, "Much work is needed to shorten the interval between pandemic declaration and vaccine availability." They voiced concern that in a more severe pandemic, 6 months "may simply be too long."

Participants suggested, among other things, that authorities should "underpromise and overdeliver" on vaccine supplies and that federal authorities should partner more closely with vaccine producers to ensure they have the most up-to-date information.

Vaccine distribution
The federal government paid for the vaccine and allocated it to states on the basis of population, which distributed the doses in various ways. "The diversity in approaches meant that neighboring jurisdictions often had different distribution systems. This caused confusion and communications challenges, some participants noted," the report says. State decisions about how to follow the ACIP recommendations strongly influenced distribution strategies.

The model for distribution was the Vaccines for Children (VFC) program, in which healthcare providers work with public health agencies to provide vaccines to certain groups of children, the report notes. Many components of the VFC program, such as provider-registration systems, proved helpful during the campaign. Some participants said the lack of an adult vaccination program analogous to the VFC program posed challenges during the effort.

The report reviews the distribution systems used by several different states, by the Department of Defense, and in American Indian tribal areas.

Participants suggested that authorities continue to use the VFC infrastructure as the basis for emergency vaccine delivery programs and consider developing an adult vaccination program similar to the VFC. They also called for better systems for tracking vaccine distribution and suggested that the federal government should deal directly with tribes.

Implementation of ACIP guidance
Different jurisdictions varied considerably in how strictly they followed the ACIP guidance on who should be vaccinated, the report says. Some were fairly strict, while others didn't turn away anyone who showed up at mass vaccination clinics.

One challenge was that the ACIP recommendations didn't entirely match previous pandemic planning documents, which had been developed with H5N1 avian flu in mind. The latter called for priority immunization of first responders and critical infrastructure workers, but ACIP's guidance did not. Educating law-enforcement groups about the change and the rationale was a challenge.

Another challenge was the exclusion of elderly people from the ACIP recommendations. This was a special problem 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 elders are highly respected role models and messengers in their communities."

Most jurisdictions opened up vaccination to everyone in December, after supplies improved. But the ensuing weak demand taught the lesson that this step does not necessarily lead to an increase in vaccine uptake, the report says. One possible reason is that many people may have assumed that the vaccine would never be available, and by the time it was, they were no longer interested.

"Anecdotally, it was probably 4 to 6 weeks that we really had people's attention, and then after that they started to trickle off quickly," one workshop particpant said.

A few participants felt there were problems with the ACIP recommendations during the vaccine shortage. One official said it became clear that the mortality was greatest in adults between 25 and 64 years with underlying disease, who were included in the broad ACIP target group but not in the subset of groups who had priority if supplies were short.

Another participant said the ACIP discussed in October whether to revise the recommendations to include adults in the subset of priority groups. But he said the panel decided not to make the change, fearing that it might cause confusion and noting that local officials had flexibility to vaccininate those they deemed to be at highest risk.

The report also says that uptake of the intranasal vaccine was low among healthcare providers and the public, often because of unfounded concerns about both transmission to patients and vaccine efficacy.

Vaccine uptake in special populations
The working group singled out three undervaccinated groups that require more intensive efforts to encourage immunization in advance of the next public health emergency: pregnant women, healthcare workers, and racial and ethnic minorities.

The 2009 H1N1 vaccination rate in pregnant women was higher than in previous flu seasons but was still disappointingly low, given the high risk of flu complications in this group that played out during the pandemic.

Working group discussions revealed several barriers to immunizing pregnant women. For example, some told of instances in which a woman's obstetrician didn't have vaccine supplies and sent her to a primary care provider for the 2009 H1N1 vaccine. Then the primary care provider, citing unfamiliarity with vaccinating pregnant women, sent her back to the obstetrician.

An overarching solution to lagging flu vaccination rates in pregnant women is to institutionalize them, the group said. Vaccine should be available in obstetricians' offices. They suggested that other measures could include electronic standing orders to offer flu vaccine to pregnant patients, educating healthcare workers about the benefits of vaccination, and increasing the number of obstetricians who administer the flu vaccine.

In healthcare workers, 2009 H1N1 vaccine uptake was about 37%, but rates were higher in some groups, such as college healthcare providers, who had rates as high as 75%, according to the report. Though some states and institutions are gravitating toward mandatory vaccination for healthcare workers as a tool to raise rates, some working group members suggested that other strategies could include incentives and educating workers about the safety and usefulness of flu vaccines.

In minority groups, vaccination rates were low, especially in African Americans—a pattern public health officials have seen for other immunization efforts, the workgroup wrote. To reverse the low vaccine turnout in minority groups, public health workers need to develop strong partnerships with communities before the next health emergency. The report also suggests that experts identify a set of best practices for successfully reaching minority communities with flu vaccine.

Communication and media issues
The communications portion of the IOM report focuses mainly on issues surrounding the 2009 H1N1 vaccine. Though participants gave high marks to the Centers for Disease Control and Prevention (CDC) for their overall communications strategies, they said two factors presented states and local officials with enormous challenges: early high demand for the vaccine when supplies were short, and complex messages about vaccine formulations and priority groups.

Workgroup members said that details about the CDC's communication plan needed to be available earlier to give states and local groups more time to tailor messages to their own needs. They said professional groups such as the Association of State and Territorial Health Officials (ASTHO) and the National Association of County and City Health Officials (NACCHO), with their useful resources, helped public health officials navigate difficult communications problems.

Another gap was communications to physicians, the report said. In many instances, physicians didn't receive faxed health alerts; in other instances, e-mail systems weren't in place to deliver them. Medical associations that had existing relationships with physician groups helped fill some of the void during the pandemic, they added.

The pandemic experience showed that public health officials couldn't depend on media venues for all of their communications efforts because some geographic regions had spotty coverage. However, the authors reported that one media format—call-in live TV and radio shows—were very useful for educating and reassuring the public.

Group members had lists of recommendations for coordination of communications within the public health setting, with healthcare providers, and with the public and the media. For example, they suggested that the National Public Health Information Coalition develop a way to rapidly share focus group findings and communications materials during future emergencies. Participants also suggested using school-system automated phone networks to reach parents with vaccine information.

Funding and payment issues
Although the federal government shouldered the cost of the vaccine, as well as its distribution and administration, public health departments, doctors' offices, and pharmacies reported several financing gaps, such as transportation, storage, staffing, and managing vaccination data. Some health officials told the working group that federal grants didn't always line up with state or local needs and that a simpler, quicker way is needed to obtain the grants.

Several health officials worried how they will maintain the infrastructure needed to respond to an emergency such as the pandemic, given chronic erosion in public health funding and staffing.

Participants reported several glitches with insurance reimbursement. For example, doctors did not have a CPT code for 2009 H1N1 vaccine administration when the vaccine was first available; then later, federal officials had two codes, which was confusing.

Some insurance plans that offered companies self-insurance products ran into problems when companies opted not to cover the vaccines, even though the corporation did, workshop participants noted.

The workgroup suggested that federal officials huddle with insurance plan providers to hammer out the issues addressed in advance of the next public health emergency.

See also:

IOM report

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