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Testimony on the Immunization Grant Program of the PHS Act by Walter A. Orenstein, M.D.
Director, National Immunization Program
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

Before the Senate Committee on Labor and Human Resources, Subcommittee on Public Health and Safety
May 6, 1997

Introduction

Mr. Chairman, I am Dr. Walter Orenstein, Director, National Immunization Program, Centers for Disease Control and Prevention (CDC). I am pleased to appear before the Subcommittee to discuss reauthorization of the Immunization Grant Program (Section 317 (j)(1)) of the Public Health Service (PHS) Act.

The immunization grant program (referred to as the 317 program), which was created in 1962 by the Vaccination Assistance Act, is one of the most successful prevention programs in public health. The 317 program has vaccinated millions of children, averted millions of cases of disease, saved billions of dollars, and provided a greatly needed structure within States to assure that children receive vaccinations. Without the 317 immunization program, our most vulnerable resource, our children, would be at risk for diseases easily prevented by simple vaccination. The 317 program, which comprises $288 million of the President's $427 million budget request for PHS Act immunization activities, supports many of the efforts included in the Childhood Immunization Initiative, a comprehensive national response to assure that our nation's children are protected against deadly vaccine-preventable diseases. I would like to take this opportunity to tell you where we are now, highlight success stories of the program, describe why reauthorization of the immunization grant program is essential and discuss future challenges.

Vaccines are Cost-Effective

Few measures in public health can compare with the benefits of vaccines. Cost-benefit analyses have been performed for vaccines routinely recommended for children. Four of the vaccines, diphtheria and tetanus toxoids and pertussis vaccine (DTP), measles, mumps, and rubella vaccine (MMR), polio vaccine, and Haemophilus influenzae Type b (Hib) vaccine accrue direct medical savings for each dollar spent to assure children are immunized against these diseases (Table 1). Varicella vaccine saves roughly 90 cents in direct medical costs for every dollar invested, while the perinatal and infant hepatitis B vaccination results in savings of 50 cents for every dollar spent. However, when indirect savings are also measured, which includes prevention of work loss by parents to take care of ill children, prevention of death, and prevention of lost earnings from disability, all of the vaccines routinely recommended for children are highly cost saving, ranging as high as $29 saved for every dollar spent on DTP, to $2 saved for the hepatitis B vaccine.

Table 1. Benefit-Cost Analysis of Commonly Used Vaccines (Savings per Dollar Invested)
Vaccine	Direct Medical Savings	Direct + Indirect* Savings
DTP	$6.00	$29.10
MMR	$10.30	$13.50
OPV	$3.40	$6.10
Integrated Schedule (DTP,MMR,OPV combined)	$7.40	$25.50
H. Influenzae type b	$l.40	$2.20
Hepatitis B- perinatal and infant	$0.50	$2.00
Varicella	$0.90	$5.40
* Indirect Savings includes work loss, death, and disability Source: Orenstein, Walter A., Hadler, Stephen, Wharton, Melinda, "Trends in Vaccine-Preventable Diseases," Seminars in Pediatric Infectious Diseases, Vol 8, No.1 (January) 1997: pp 23-33.

Record Low Disease Levels and Record High Immunization Rates

The benefits of the Immunization grant program, State and local efforts, and other federal assistance for childhood vaccination purchase, such as the Maternal and Child Health Block Grant and the Vaccines for Children Program (VFC) are reflected in low disease levels. Widespread use of vaccines, particularly among children, has resulted in record low levels of disease. Vaccine-preventable diseases have declined by at least 97%. (Table 2). Provisional data for 1996 show that record low levels were reported for mumps, tetanus, polio and invasive Haemophilus influenzae (for children under 5 years of age). Only one case of diphtheria was reported, and fewer than 500 measles cases were reported, down from more than 27,000 cases at the peak of the measles resurgence in 1990. The one exception to these low disease levels is pertussis. It is now predominately occurring in older children, adolescents, and adults who are not eligible for vaccination with currently licensed pertussis vaccines.

Table 2. Comparison of Maximum and Current Morbidity, Vaccine Preventable Diseases
	Maximum Cases	1996 Provisional Cases	Percent Change
Diphtheria	206,939	1	- 99.99
Measles	894,134	488	- 99.95
Mumps	152,209	658	- 99.57
Pertussis	265,269	6,467	- 97.56
Polio (paralytic)	21,269	0	-100.00
Rubella	57,686	210	- 99.64
CRS	20,000*	2	- 99.99
Tetanus	1,560**	27	-98.27
H. influenzae	20,000*
Source: National Immunization Survey (NIS), January-December 1995

Also contributing to record low disease levels is high immunization coverage levels at the time of school entry (Table 4). These high levels are a direct result of the enactment and enforcement of State school immunization laws. Passage of these laws was based on epidemiologic evidence documenting that school-based disease outbreaks could only be curtailed by mandatory immunization.

Table 4. Immunization Levels United States, 1995-1996 School Year
Vaccine	Head Start	Day Care**	Weighted Average (%)* K-1***
DTP	94	90	96
Polio	95	90	95
Measles	96	90	96
Rubella	96	90	96
Mumps	96	90	96
*Preliminary data (44 grantees) **Licensed day care facilities ***Kindergarten/1st grade immunization assessment

Although immunization coverage is higher than ever for the U.S. as a whole, immunization coverage within the United States is not uniform. For the 4:3:1 series, coverage varied from a low of 66 percent in Idaho to a high of 89 percent in Maine for 1995, a difference of 23 percentage points. Further, coverage similarly varied among 28 large urban areas by 25 percentage points. Because vaccine-preventable diseases tend to be transmitted from person to person, as long as there are pockets or areas with low coverage, the whole country is at risk for vaccine-preventable diseases. Low coverage areas can serve as reservoirs for disease which can then be transmitted to many other communities within the United States.

The 317 Program Provides Essential Resources to States and Localities

In 1988, the Institute of Medicine (IOM) issued a report declaring the Nation's public health infrastructure to be in a state of "disarray" and in need of repair. At that time, immunization funds provided through Section 317 of the Public Health Service Act were primarily for the purchase of vaccines and the conduct of activities associated with program planning, evaluation, administration , disease surveillance, and outbreak control. Shortly after the release of the IOM report the United States experienced a major measles epidemic which lasted until 1991. A total of 55,000 cases were reported and 123 deaths occurred. In 1992, in response to this epidemic, additional 317 funds were provided to support 50 States and 28 major urban areas. These funds, for the first time, were made available to support State hiring of service delivery staff (i.e., nurses) as well as expanded immunization clinic hours. By 1995, the number of hours that public immunization clinics offered immunization services increased almost threefold, and over 3,000 staff were hired to provide clinic services. For instance, Tennessee has hired 61 additional clinic staff and increased its clinic hours by 50 percent.

Since 1992, activities have moved beyond expanding service delivery. Funds provided through the 317 program have been critical in allowing States to determine "what works" and supporting implementation of successful immunization strategies. These strategies are the cornerstone of our intervention efforts. They include linkages of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and immunization services; assessment of immunization coverage levels and practices in public and private provider settings; and use of reminder and recall systems by public and private providers. In addition, state and local immunization programs are undertaking other interventions, such as a focus on "pockets of need." adult immunization, and registries, to prevent disease.

WIC/Immunization Linkage

A critical component of an effective immunization delivery system is linkage with the WIC Program. WIC is the largest single point of access to health-related services for low-income preschool children. About 1.8 million infants (45% of the U.S. birth cohort, in some cities higher than 70 %) participate in WIC. Studies have indicated that strategies to improve coverage among WIC participants are effective. For example, in Chicago, Boston and Chattanooga, TN, immunization coverage rates for 2-year olds increased by 17 to 26 percentage points over baseline within 12 months of program implementation. State immunization programs report that approximately 75% of pre-school WIC participants are being assessed for immunization status and referred to a physician ff vaccination is needed. In 1997, CDC estimates that $14.7 million in 317 funding is being used to support formal WIC/Immunization linkages in all States. WIC has done an excellent job of reaching out to high risk individuals, and we need to continue to work collaboratively with WIC to take advantage of that access for the benefit of the children.

Clinic Assessments

Assessment of immunization coverage levels and practices in public and private provider settings is another key strategy to increase immunization rates. State or local health officials review the immunization records of infants and preschool-aged children attending a clinic or provider's office, and give feedback to the provider about those records. States encourage incentives for improved performance such as community-based banquets, news media coverage, and awards; and encourage exchange of information to stimulate competition between providers. Such assessment has been shown to be effective in improving coverage levels, especially when (1) feedback to providers includes diagnosis of the reasons for low coverage and is used to devise and implement practice-based solutions, (2) improved performance is recognized, and (3) competition between providers develops. Several States, such as Georgia, Iowa, Colorado, Missouri, and Illinois, have used assessment practices for three or more years and have shown gradual and consistent improvement in public sector coverage levels. For example, median series-completion rates in public clinics for the 4:3:1 series increased from 26% to 65% in Colorado, and from 45% to 81% in Missouri. Since 1996, States have been conducting assessments in all public health department clinics and are currently expanding assessment activities in private provider settings. In 1996, for example, Maine completed assessments in all public and private provider offices throughout the State.

Reminder and Recall

Evidence supports the effectiveness of reminder and recall systems at improving immunization coverage levels among children and adults. Among six published studies, the median increase in vaccination rates in children was 17%. These systems are cost-effective. A 1997 study reported "the cost per additional child appropriately immunized was $4.04." CDC recommends the use of reminder and recall systems in public health clinics and in private practitioner's offices.

Pockets of Need

Although coverage for preschool immunization is high in many States, pockets of need, or areas within each State and major city where substantial numbers of under immunized children reside, continue to exist. These areas are of great concern because, particularly in large urban areas within traditionally undeserved populations, they have the potential to spawn outbreaks of vaccine-preventable diseases. These areas must be identified and activities targeted to improve coverage in the most hard-to-reach populations to ensure at least 90% immunization levels. Funds from the 317 program are instrumental in helping States identify pockets of need and stimulating full implementation of key strategies in these areas.

In addition to substantial State efforts to address pockets of need, other related 317 funded projects are underway. At the direction of Congress, 317 funds were awarded last year to support childhood demonstration projects in community health networks in three urban areas: Detroit, San Diego, and New York City, and one rural area consisting of four counties in Colorado. These projects will demonstrate whether an academic medical center can, using its community ties and influence, raise immunization coverage in their community's clinics and in peripheral provider sites through training and education.

Also, in 1997, funds were awarded to support immunization demonstration projects in public housing authorities, where children of parents with risk factors are likely to exist. These projects will be instrumental in determining methods to improve immunization coverage among children residing in public housing. Immunization grant funds were also awarded to four school-based demonstration clinics in New York, West Virginia, South Dakota, and Wisconsin to determine if these school-based clinics can help raise immunization rates in their communities.

Adult Immunization

An important part of the 317 program is State efforts to increase adult immunization. Before recent increases in vaccine coverage, each year as many as 50,000 U.S. adults died from influenza, pneumococcal infections, and hepatitis B. The overall cost to society of these and other vaccine-preventable diseases of adults has exceeded $ 10 billion each year. To further address this important issue, the Department of Health and Human Services has established an Adult immunization Working Group to develop an action plan to reduce vaccine-preventable disease in adults.

State-based Immunization Registries

Registries provide critical information needed to improve and sustain coverage. Such State-based registries fill the information gap by consolidating scattered records across providers; rapidly identifying the specific vaccines a child requires at each visit; promoting automated and aggressive recall of under-immunized children; and providing practice- and community-based immunization coverage assessments so data can be used to promote immunization at every opportunity and in every pocket of need. In 1996, approximately $41 million in 317 grant funds were spent on activities supporting the development and implementation of immunization registries and associated linkages with WIC programs. Thirteen of the 50 states reported having in operation immunization registries in all public sites, with 30 states and the District of Columbia having registries in one or more public sites.

Reauthorization of the 317 Immunization Grant Program is Essential

Since the beginning of the 317 program, millions of cases of vaccine-preventable diseases have been averted. For example, more than 1.5 million cases of measles are averted each year due to public health efforts. Similarly, over 10,000 cases of paralytic polio are prevented each year'. In addition to this significant disability and death averted, it is estimated that well over $1 billion are saved annually from the prevention of polio and measles alone. The 317 program is an example of a powerful and cost-effective partnership between Federal, State and private organizations.

The 317 Program provides essential resources to States to conduct critical vaccine-preventable disease activities. This Program is the backbone of the States' prevention efforts. Funds are provided to purchase vaccines, employ State and local immunization staff, and operate immunization clinics. In addition, States conduct essential disease surveillance and outbreak control, outreach, education, registry-building, and other activities.

Reauthorization of the 317 program is essential. First, we must maintain the significant achievements in disease reduction and dollar savings. We cannot lower our guard. Every day about 11,000 babies are born in this country. Each of these children starts with an immunization coverage of zero. That is why our responsibility to our Nation's children never ends; it must be sustained every day of every year. Second, we must enable States to build the vaccine delivery systems that will assure the protection of future generations of our Nation's children. To build these systems, much remains to be done. For example, completing State-based immunization registries is the cornerstone of assuring disease prevention. More work needs to be done further addressing Pockets of regarding fully implementing proven immunization strategies and need.

Future Challenges to the Immunization Grant Program

A thoughtful biology-watcher (Lewis Thomas) once predicted that one thousand years from now our era in history will be known as the Age of Biotechnology, because of our growing ability to purposefully manipulate and harness the molecular structures of living organisms. Nowhere is this technology more evident than in the field of immunization. Almost a century passed between the very first vaccine -- Edward Jenner's preventive for smallpox in 1796 -- and the second one for rabies by Louis Pasteur in the 1880s. By about the middle of the 20th Century, vaccines for another two dozen diseases -- from diphtheria to polio to measles -- were introduced.

Now, the pace of such progress is quickening even more. Since 1990, several major changes have been made to the routine childhood immunization schedule, including infant vaccination with Hib and hepatitis B, routine early childhood vaccination against chickenpox, and replacement of existing polio and pertussis vaccines with safer vaccines.

Improved vaccines for Streptococcus pneumoniae may finally work in the under-two age group, for whom current vaccines do not protect infants. Among children under 2 years of age, this pneumococcus bacterium causes an estimated 9 million ear infections, 9,000 serious blood-stream infections, and about 1,500 cases of meningitis. With the trend for increased resistance to antibiotics by these bacteria, these new vaccines will be very useful and likely quite cost-effective. Also, a new vaccine for Lyme Disease may afford protection from this cause of arthritis and other medical complications for residents of the New England, Mid-Atlantic, Great Lakes, and Pacific Northwest regions where this tick-borne disease occurs.

On the horizon are vaccine technologies that would have been considered science fiction just a decade ago, but are now reported at scientific meetings. Snippets of synthetic DNA have worked as experimental vaccines in animals. Edible plants have been bioengineered to become vaccine factories, potentially reducing the costs of manufacture. (The challenge here might be to get our children to eat their vegetables.) Vaccines have been enclosed in microscopic capsules, permitting them to be released slowly over time to avoid the need for booster shots, or to be taken orally. New chemical molecules -- called "adjutants" -- have increased the effectiveness of otherwise weakly-performing vaccines.

These are wonderful fruits of the revolution in biotechnology. But they pose daunting challenges for those of us in public health responsible for putting vaccines to use in preventing disease and thus reducing health care costs. The recommended immunization schedule is already quite full, sometimes requiring three or four shots on a single visit, which doctors and parents may be reluctant to give to a frightened child. While not a part of the 317 program, the VFC program provides the financial security needed to make the national immunization system truly viable and permanent. The VFC program ensures that, as new and combination vaccines are introduced and recommended, children in all States will have equal access to new vaccines.

We are working to anticipate the problems and address the issues posed by an ever-increasing number of new and combination vaccines. This involves essential cooperation with our partners in the diverse community involved in disease prevention through immunization, including public health agencies at local, state, federal, and international levels; nongovernmental organizations of medical providers and others promoting health; manufacturers who invest, research, and develop our vaccines; those in academia who provide us their expertise and advice; and others.

Conclusion