Walter A. Orenstein, M.D., CDC

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Testimony
Before the Committee on Health, Education, Labor and Pensions
United States Senate

Responding to the Challenges of the 21^st Century: CDC's National Immunization Program

Statement of
Walter A. Orenstein, M.D.
Director
National Immunization Program,
Centers for Disease Control and Prevention,
Department of Health and Human Services

For Release on Delivery
Expected at 10:00 am
on Tuesday, November 27, 2001

Good morning Mr. Chairman and members of the Committee. My name is Walter A. Orenstein, M.D., Director of the National Immunization Program (NIP), Centers for Disease Control and Prevention (CDC). I'm pleased to be here today to speak about the benefits achieved through widespread immunization and the public health challenges the immunization program faces in the 21^st century.

Today's hearing asks if the National Immunization Program is ready for the 21^st Century. I am here to tell you that we made significant advances at the end of the 20^th Century, and are well poised to face the challenges of the 21^st. Challenges remain, however, as I will outline in my testimony and the National Immunization Program looks forward to working with the Committee to ensure that we meet these challenges.

Let me begin by thanking the Committee for its support of immunizations. Some of the successes I will discuss are due to that support. As a result of our immunization program, millions of children have been vaccinated, millions of cases of disease, disability and death have been averted, and billions of dollars have been saved. I would like to discuss some of these achievements and discuss future challenges.

IMMUNIZATION ACHIEVEMENTS

Immunization has been cited as one of ten top public health achievements of the 20^th century. (See Appendix 1). Smallpox has been eradicated as a naturally occurring disease and we are nearer than ever to achieving worldwide eradication of polio. The number of measles cases in the U.S. is at a near record low, measles is no longer endemic in the U.S., and we are close to the interruption of measles transmission in the entire Western Hemisphere. And, in a few short years since the licensing of a vaccine, chickenpox cases and accompanying hospitalizations have been dramatically reduced. Furthermore, since October, 1994, the Vaccines for Children (VFC) program has been providing publicly purchased vaccine to eligible children at no charge to both public and private providers. By eliminating vaccine cost as a barrier to immunizing children eligible for VFC, children can now be vaccinated in their medical home, (i.e., their doctor's office) instead of having to make an extra visit to a health department clinic for free vaccines.

We have made outstanding progress in increasing the U.S. immunization rate in children by the time they are 2 years of age. Coverage for most vaccines is 90 percent or higher. (See Appendix 2). However, despite these gains, every day in the U.S., 11,000 babies are born who must be vaccinated. To be protected against 11 vaccine-preventable diseases (See Appendix 3), they require 16-20 doses or injections by 2 years of age, a challenge for any health care delivery system. Recent small, but significant, decreases in coverage for some vaccines indicate we cannot take for granted that past successes will automatically translate into future successes. Thus, we must commit to sustaining and improving our immunization system.

We are also working to improve immunization of our adult population. The loss of life and costs from adult vaccine-preventable diseases are staggering. Each year, about 30,000 adults die from complications of influenza, pneumococcal disease, and hepatitis B, diseases preventable by vaccination. Influenza and pneumococcal immunization rates for adults 65 years of age and older, while increasing, are still well below 90 percent coverage goals.

Record or Near Record Lows in Vaccine-Preventable Diseases and High Vaccination Coverage in Two Year Old Children

Annual reported cases of diphtheria, measles, mumps, rubella, congenital rubella syndrome, and Haemophilus influenzae type b (Hib) have been reduced by over 99 percent from prevaccine-era levels during the 20th century. The last case of indigenously acquired wild polio in the United States occurred in 1979, and many other childhood diseases are currently at record or near-record lows.

We have achieved these record or near-record low levels of childhood disease by having high levels of childhood vaccination coverage. Immunization levels for most individual vaccines such as measles, polio, Hib, hepatitis B and 3 doses of diphtheria-tetanus-acellular pertussis (DTaP) are at 90 percent or higher. To put recent improvements for vaccination in perspective, in 1991, only 37 percent of the nation's children received a combined series of four doses of DTP containing vaccine, three doses of polio vaccine, and one dose of measles-mumps-rubella (MMR) vaccine, also known as the 4:3:1 series. For 2000, the coverage level for the 4:3:1:3 series, which also includes three doses of the Haemophilus influenzae type b (Hib) vaccine, was 76 percent.

Disparities in immunization coverage rates between racial and ethnic groups have also been reduced. In 1970, the measles immunization rate for racial and ethnic minority children was 18 percentage points lower than the rate for white children. In 2000, the gap between white, non-Hispanic children, Hispanic children, and black children was less than 4 percentage points. Disparities among these three groups in coverage of Hib, hepatitis B, polio, and varicella vaccines were four percentage points or less in 2000. However, in 2000, significant disparities existed between racial and ethnic groups for the 4:3:1:3 series, indicating more could be done.

Despite significant improvements between 1999 and 2000 in coverage for hepatitis B and varicella vaccines, there have been some slight but statistically significant decreases in coverage for the combined 4:3:1:3 series of 2 percent. This decrease is a warning that we cannot take high immunization coverage levels for granted.

Elimination of Endemic Measles in the U.S. and the Americas

Because of the widespread use of measles vaccine, measles is no longer an endemic disease in the United States. All cases today represent importations with limited domestic spread. Over the past decade, we have dramatically increased first dose coverage among preschool children and we have provided a second dose for the majority of school children. Before 1985, measles coverage for 2-year old children never reached more than 70 percent. The U.S. experienced a resurgence of measles in 1989-1991, with more than 55,000 cases and 11,000 hospitalizations reported, resulting in 123 measles-associated deaths. In 1990 alone, more than 27,000 cases of measles were reported. We have made great progress since then: in 2000, fewer than 100 cases were reported.

Even though we have eliminated endemic measles, importations will continue to occur while measles is endemic in other countries. We have supported other countries in their fight against measles and this has helped to reduce the number of internationally imported cases from over 300 in 1990 to an average of less than 50 imported cases per year in the last five years. CDC is the leading technical and donor partner with the Pan American Health Organization, whose leadership has reduced measles cases in the Americas by >99 percent from about 250,000 in 1990 to <500 in 2001. Nevertheless, because measles importations from around the world continue to occur, there is a potential for measles epidemics to recur in the United States unless high immunization coverage is maintained for each new cohort of approximately 4 million children, born annually.

Reduction in Varicella (Chickenpox) Cases and Hospitalizations

Prior to the availability of varicella (chickenpox) vaccine, there were approximately 4 million cases a year in the U.S. Although varicella is frequently perceived as a disease that does not cause serious illness, many are not aware that an average of 11,000 hospitalizations and 100 deaths occurred per year in the United States before varicella vaccine became available. The majority of deaths and complications occurred in previously healthy individuals.

Varicella vaccine was licensed in 1995 and CDC contracted for this vaccine and began distribution in 1996. From the time of vaccine licensure, CDC conducted active surveillance for varicella cases in three areas in the United States: Antelope Valley, CA.; Travis County, TX; and West Philadelphia, PA. Between 1995 and 2000, there was a 78 percent decline in the number of reported varicella cases in these sentinel sites and a 65 percent decrease in hospitalizations.

Adult Immunization Coverage Rates Continue to Improve

The impact of vaccine-preventable diseases in adults in the U.S. is staggering. Fortunately vaccines can protect adults from influenza, as well as many other potentially debilitating diseases, such as pneumococcal disease and hepatitis B. While progress is being made in immunizing the adult population against these diseases, some improvements could help us meet our public health goals.

By 1999, among persons >65 years of age, vaccination levels approached or exceeded the 60 percent national Healthy People 2000 objective in all states for influenza vaccination, and in 24 states for pneumococcal vaccination.

In 2000, among persons >65 years of age, 64 percent reported having received influenza vaccine in the previous year, and 53 percent reported having ever received pneumococcal vaccine, as compared to 33 percent and 15 percent, respectively, in 1989.

Despite these gains, we still have not reached our goal for 2010 of 90 percent vaccination coverage for influenza and pneumococcal vaccines.

Achieving Global Polio Eradication

Extraordinary progress has been made toward global polio eradication. In 1988, polio existed in over 125 countries on five continents. As of 2001, polio was detected in just 11 countries. Global polio incidence has declined by more than 99 percent from about 350,000 cases in 1988 to less than 3,000 in 2000. Type 2 wild poliovirus (one of three types of poliovirus) has not been detected since 1999 and may have already been eradicated.

IMMUNIZATION CHALLENGES

It is currently recommended that all children be vaccinated against 11 diseases and that many adults receive influenza, pneumococcal, and hepatitis B vaccines. This requires that adequate supplies are available to meet the needs of all those children and adults and that there is a vaccine financing, distribution, and administration system to provide 16-20 doses of vaccines to children by age 2, an additional 4 doses later in childhood, and a system to identify and vaccinate adults in need. Although substantial progress has been made, the current immunization program still faces some challenges.

Fragility of the Vaccine Supply

One of the most critical challenges is addressing the fragility of the vaccine supply. The nation is experiencing shortages of vaccines against four of the eleven diseases preventable through routine vaccination of children: diphtheria, tetanus, pertussis, and pneumococcal disease, and delays in vaccine availability for influenza vaccine which is recommended for many adults and children. Today's supply problems are multifactorial, complex, and vary from vaccine to vaccine and manufacturer to manufacturer. The issues now include manufacturer withdrawal from the market, difficulty in complying with Good Manufacturing Practices established by the Food and Drug Administration, and insufficient stockpiles of vaccines to be used to mitigate the impact of any transient supply disruptions. We appreciate your concern with vaccine shortages and believe that your request of the General Accounting Office to study these issues will be useful to better understand the problems and identify solutions. We are cooperating with the GAO and look forward to their report.

Addressing these shortages has been challenging. CDC has taken action to help ameliorate problems associated with the vaccine supply by: (1) changing vaccination schedules to reduce the number of doses from optimal protection to what can be managed given limited vaccine supplies, (2) monitoring the manufacturers' production and release of vaccines through voluntary communications, and (3) managing as best as possible the purchase, ordering, and distribution of vaccines purchased by states through the federal contracts to facilitate equitable distribution of the limited supplies.

For the longer term, we are working closely with the National Vaccine Advisory Committee to evaluate the reasons for the current supply problems and recommend solutions to prevent vaccine shortages.

Since 1983, CDC has been operating stockpiles of certain vaccines. These stockpiles are used to address short-term disruptions in the production of universally recommended vaccines.

There have been a number of instances when stockpiles were needed. Most withdrawals from the stockpiles have been made by manufacturers to address unanticipated vaccine production problems. For example, in 1986, the measles-mumps-rubella (MMR) stockpile was used to assure a continuous supply of vaccine after a fire in a manufacturing plant. In 1990, a polio vaccine stockpile was used to temporarily supply vaccine when a manufacturer experienced a delay in product release.

CDC has limited current stockpiles of vaccines to those produced by a single manufacturer for which there is a stable demand, (e.g., vaccines used for 90 percent or more of children over the years). However, the shortage of a vaccine such as DTaP, which was made by 4 manufacturers until January, 2001, when two of these manufacturers dropped out of the market, has led CDC to reevaluate what vaccines should be stockpiled. We expect this re-evaluation to be completed in the next few months.

Vaccine Financing

Another important aspect of assuring vaccine availability is that of vaccine financing.

Financing for immunizations is frequently (though not always) provided through employment-based and other private purchase insurance, the Vaccines for Children (VFC) program, the State Children's Health Insurance Program (SCHIP), and Medicare. Yet while these private and public health insurance programs account for the majority of immunizations provided nationally, they do not offer the U.S. population seamless and universal coverage. The federal Section 317 categorical grant program and state vaccine purchase programs address residual needs and serve as an important safety net in reducing gaps and uncertainties in these health financing plans. Specifically, the Section 317 and state vaccine purchase programs focus particularly on providing vaccines for children who have health insurance but whose insurance either does not cover immunization or has large deductibles, children who are considered "underinsured."

Due to advances in biotechnology and vaccine safety, the number of routinely recommended vaccines has been expanded to control newly-preventable diseases, and the composition of some vaccines has been changed to provide the safest vaccines possible. The Advisory Committee on Immunization Practices (ACIP) continually makes new recommendations to the vaccine schedule to further protect the health of our nation's children. These recommendations for routine use of additional vaccines to prevent disease result in increased vaccine purchase costs for the immunization program. The cost, using the CDC contract, of purchasing the vaccines to fully vaccinate a preschool child has increased from approximately $130/child in 1990 to approximately $394/child in 2001. For example, the cost of the new pneumococcal conjugate vaccine is about equivalent to the total combined costs of all other pediatric vaccines in the recommended schedule.

CDC is working to address these challenges. In September 2001, CDC awarded a contract to the Institute of Medicine (IOM) to develop a study on vaccine financing in the U.S. This study will examine federal and state budgets for the public vaccine supply and consider other finance mechanisms that might be helpful to improve vaccine availability, such as increased coverage for vaccines in private insurance plans. Among the issues the IOM will address are the roles of public (federal, state, and local) and private (health plans, health insurers, and purchasers) agencies in financing the purchase and administrative costs of vaccines in the United States. A report is expected by April, 2003.

Developing state and local community-based Infrastructure

Any effective immunization program should have two major components, and should be complementary to other existing public and private immunization programs. First, vaccine must be available. Second, a vaccine infrastructure should be in place to assure the vaccine is appropriately distributed, physicians and nurses are trained to administer the vaccine properly, adequate staffing is available to provide vaccines in clinics at convenient hours, outbreaks are detected and controlled, individuals are found and communities identified that are not adequately vaccinated and measures initiated to immunize them, and a host of other functions.

As additional vaccines are licensed which can reduce vaccine preventable diseases, additional burdens are placed on the State and local health departments to provide more immunization services to broader populations. Diverse populations require targeted outreach and educational activities which can be provided by state and local health departments. For example, existing linkages between the U.S. Department of Agriculture's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and State and local immunization programs can enhance immunization coverage levels. In addition, State programs to train providers in vaccine

handling and administration are an important part of immunization programs. The IOM highlighted the need for improved immunization infrastructure and called for increased funding in their report "Calling the Shots, Immunization Finance Policies and Practices."

The additional $42.5 million dollars appropriated by Congress in FY 2001 was awarded by CDC to all States, through our grant program, to assist them in improving immunization service administration, developing state-based immunization registries, improving linkages with WIC programs (which serve many children at high risk of being underimmunized), and providing public and professional information and education, among other activities.

The Vaccine Safety Challenge

Immunizations are subject to a higher standard of safety than other medical interventions because they are given to healthy people. Like all medical interventions, no vaccine is 100 percent safe or effective. Vaccine safety activities are needed to maintain public confidence in immunizations, preserve high coverage levels, and prevent a resurgence of vaccine-preventable diseases. The tremendous reduction in the occurrence of vaccine-preventable diseases, combined with the increased public attention on vaccine safety concerns, has resulted in some individuals questioning the important public health role of immunizations. To maintain confidence in immunizations, we must have a better understanding of which risks are truly attributable to vaccines, the magnitude of the risks, the groups at greatest risk of adverse events, the pathophysiology of adverse events, and the ability to effectively evaluate and treat adverse events. CDC has developed several projects to help address these needs. One project is a newly-funded Clinical Immunization Safety Assessment (CISA) network to assess individuals with selected adverse events and offer recommendations for management. CDC also funds a Vaccine Safety Datalink (VSD) project which collects population-based data on vaccine safety by utilizing medical care data from 8 managed care organizations around the United States. This system helps in determining whether adverse events following vaccination are causally related or are coincidentally related. Finally, CDC and NIH have contracted with the Institute of Medicine to provide independent review of emerging information concerning adverse events associated with vaccines. These reviews will address whether the available evidence supports a role for vaccine in causing the adverse event and recommendations for future research and public health actions.

Continuing Challenges to Improving Adult Immunization

Most domestic vaccine-preventable disease morbidity and mortality occurs among adults, primarily resulting from complications associated with influenza, pneumococcal disease, and hepatitis B infections. An annual average of approximately 20,000 deaths and 110,000 pneumonia and influenza hospitalizations result from influenza infections. In recent years, approximately 6,000 deaths and over 45,000 severe cases of pneumococcal disease have occurred among adults in the U.S. Despite availability of a highly effective vaccine, approximately 80,000 persons, mostly adolescents and young adults, are infected with hepatitis B virus annually in the U.S. About 5,000 of these newly-infected persons are hospitalized, and 5,000 become chronically infected. An estimated 1.25 million persons in the U.S. have chronic hepatitis B infection, facing a 15 percent-25 percent risk of dying from chronic liver disease or hepatocellular carcinoma and serving as a reservoir for continued hepatitis B transmission. Annually, about 4,000 to 5,000 of those chronically infected die.

Despite recent improvements I noted earlier, vaccination coverage levels among adults for whom CDC recommends vaccination are still very low compared to levels achieved among children, and compared to the Healthy People 2010 objectives for influenza and pneumococcal vaccination (90 percent for those aged 65 and 60 percent for those aged 18-64 at high risk).

The immunization delivery system for adults is quite different from the system for children. The great majority of vaccines for adults are purchased and administered in the private sector. The major role for the public sector is to work with private providers to improve vaccination coverage of their patients and to promote immunizations among the general public. However, little public health infrastructure exists to assure adequate vaccination of adults. Targeting vaccination efforts requires an infrastructure to organize immunization providers, strategically convert non-vaccinating providers into vaccinating providers, and change practice behavior of existing providers.

Global Immunization Challenges

Each year, diseases that could be prevented with available vaccine kill 3 million children worldwide. Almost 2 million additional deaths could be prevented by vaccines now in late stages of development. The remaining challenges include: 1) ensuring adequate financial resources from all sources, including both public and private sources to complete polio eradication; 2) ensuring support for translating the success in achieving measles elimination in the Americas to implement a global initiative to prevent the approximately 800,000 childhood deaths worldwide caused by measles each year; and 3) support for the Global Alliance for Vaccines and Immunization goals to improve routine immunization services in developing countries and introduce new and underutilized vaccines such as hepatitis B and Haemophilus influenzae type b (meningitis) vaccine.

Conclusion

Thank you Mr. Chairman and members of the Committee for providing the opportunity to appear before you. The immunization program has achieved a remarkable record of success. But, our effective vaccines can only be as good as our ability to deliver them to children and adults in need. By continuing to improve the system, we as a society, and we as individuals, can gain the full benefits vaccines have to offer.