Testimony of KEIJI FUKUDA, MD

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TESTIMONY OF

KEIJI FUKUDA, MD

CHIEF, EPIDEMIOLOGY AND SURVEILLANCE SECTION

INFLUENZA BRANCH

DIVISION OF VIRAL AND RICKETTSIAL DISEASES

NATIONAL CENTER FOR INFECTIOUS DISEASES

CENTERS FOR DISEASE CONTROL AND PREVENTION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SPECIAL COMMITTEE ON AGING

U.S. SENATE

MAY 30, 2001

Good morning, Mr. Chairman. I am Dr. Keiji Fukuda from the Centers for Disease Control and Prevention (CDC). I'm happy to be here today to provide information regarding last year's influenza vaccine delays and efforts underway to help mitigate similar potential problems in the future.

Introduction

Influenza vaccine is the best tool to prevent severe illness and death related to influenza among the elderly and chronically ill in the United States. As the Nation's prevention agency, CDC's overriding public health concern is to prevent hospitalizations and deaths, especially among high risk persons. Influenza causes, on average, approximately 20,000 excess deaths and approximately 110,000 hospitalizations per year. For each 1 million persons over the age of 65 vaccinated in an average influenza season approximately 900 deaths and 1,300 hospitalizations are prevented.

The 2000-2001 vaccine delay was severe and unusual. In other seasons, the system for providing and distributing influenza vaccine has successfully met vast flu vaccine needs and in recent years has provided between 70-80 million vaccine doses annually.

Influenza vaccine is produced and primarily distributed in the private sector. CDC vaccine recommendations are made through a deliberative process involving advice and guidance from the Advisory Committee on Immunization Practices (ACIP). Although CDC's ACIP issues recommendations regarding influenza vaccination, including which groups of individuals are at highest risk for developing complications from influenza and optimal time frames for administering vaccine, influenza vaccine production is solely in the private sector, and the distribution of the vaccine is primarily through the private sector. Because of this, if vaccine manufacturers have delayed production or a shortage of flu vaccine, CDC can take steps to minimize the effects, but cannot solve the entire problem.

Flu Vaccine Production in 2000-2001

Each year, manufacturers produce a new influenza vaccine, based upon the selection of viral strains that are most likely to circulate for the upcoming influenza season. This is done to produce the most effective vaccine possible each year. A relatively short window exists between the time when viral strains are selected and when manufacturers develop and produce vaccine for each season. Delays can occur due to difficulties in growing or processing the vaccine strains or due to other manufacturing issues, and these delays in turn can affect vaccine distribution.

By June 2000, it became clear from discussions between influenza vaccine manufacturers and federal public health officials that there was a possibility of delays or shortages in influenza vaccine shipments for the 2000-2001 influenza season. This potential delay and possibility of a shortage was due to a combination of factors including difficulty by some manufacturers in growing and processing one of the virus strains used in vaccine and good manufacturing practice issues with two companies. Ultimately, a significant delay in the availability of influenza vaccine occurred, resulting in concerns regarding the distribution and pricing system of influenza vaccine. One of the four manufacturers withdrew from the market and did not distribute any vaccine.

CDC Actions

To deal with the delays and potential shortfall, CDC undertook a number of activities. CDC contracted with one manufacturer to extend their production period and produce up to 9 million additional doses of additional influenza vaccine. This decision was made to protect the nation against severe shortage. The additional vaccine was available in December 2000 and as a result, the final supply of influenza vaccine approximated what was distributed in the previous year; however, a substantial amount of vaccine reached providers much later than usual creating functional shortages for some providers. In addition to CDC's contracting for the production of additional influenza vaccine, CDC: 1) recommended that vaccine be administered to high-risk individuals first, 2) provided an internet-based system to facilitate the exchange and redistribution of vaccine, 3) conducted promotional campaigns to encourage vaccination of high risk persons, 4) communicated with health care providers and partners to keep them informed of events, and 5) encouraged states to develop plans to help manage and direct vaccine supplies in their jurisdictions.

CDC's influenza education and media campaign encouraged people at high risk of complications from influenza to seek a flu shot and to encourage healthy people 50-64 to seek flu shots in December and early January. The campaign was based on discussions with a total of 26 focus groups that were held around the country with African Americans, Spanish-speaking Hispanics and Caucasians. The groups were used to determine and test key messages. Both English-language and Spanish-language versions of the campaign materials were made available, including television, radio public service announcements, and one-page flyers.

These initiatives were undertaken to help mitigate the effect of vaccine delays. But, as previously indicated, influenza vaccine is produced in the private sector and is also largely distributed there. The Federal government does not control the private production and distribution system. Therefore, despite our best efforts, some patients (including those at high risk) and providers experienced delays in obtaining vaccine, resulting in uneven distribution. The degree of delay experienced by individual providers varied greatly, depending on the vaccine manufacturer, distributor, and when vaccine was ordered.

The GAO Report entitled, "Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High-Risk People," looked at these issues. In general, CDC agrees with the GAO report and continues to take a leadership role in supporting efforts to address influenza vaccination. As GAO acknowledges, the purchase, distribution, and administration of influenza vaccine are mainly private-sector responsibilities. Substantial efforts have been made by the Department to address future influenza immunization concerns. CDC is working proactively with the Food and Drug Administration, manufacturers, distributors, State and local health departments and other key partners to better prepare for the upcoming flu season.

The Upcoming Flu Season: What We Expect

Three manufacturers are currently producing influenza vaccine for the U.S. population. Each has provided an estimate of vaccine production for the upcoming year. Based upon the manufacturers' estimates, the total possible vaccine available in the 2001-2002 influenza season may be up to 84 million doses. In a usual year, approximately 70-80 million doses of vaccine are distributed. However, it's important to note that the manufacturers' estimates are subject to change, and it is not possible to know for certain how much vaccine may be available, or when it may be available, until much later this year.

Because influenza vaccine is newly produced for each influenza season, numerous factors may affect the manufacturers' vaccine production and distribution. If some manufacturers are delayed in getting their vaccine to the providers, there will be uneven distribution of the vaccine with providers who ordered from some manufacturers receiving vaccine later than providers who ordered from other manufacturers. Further, providers who order late may receive vaccine late. Providers who order from third party distributors will be dependent upon which manufacturer is supplying that distributor.

CDC Plans

CDC has been working with the private sector, state and local health officials and provider organizations in the development of contingency plans and is taking steps to help assure high-risk patients are vaccinated in the event of a delay or shortage. Several activities are underway and planned to anticipate and deal with potential problems.

1) CDC and the American Medical Association hosted a meeting on March 27, 2001 with manufacturers, selected distributors, trade organizations, provider organizations and public health officials to discuss the need for contingency plans and to learn more about the private sector production and distribution challenges.

2) CDC has requested that states develop contingency plans in the event of an influenza vaccine shortage and has provided written guidelines to assist them in planning. CDC requested that states submit their draft contingency plans by June 2001. CDC will hold a workshop at the National Immunization Conference this week to share planning efforts and best practices so that plans can be finalized by August of this year. CDC will also share state plans as they become available.

3) CDC also plans to send letters to health care provider organizations serving high-risk populations, including nursing homes, specialty physicians, and will work with Health Care Financing Adminstration (HCFA) to notify providers who participate in Medicare reimbursement plans, reminding them to order vaccine now and to immunize high-risk individuals at the earliest possible time.

4) One manufacturer has indicated it plans to fill approximately 25% of each customer's order in September. If, after that, a vaccine shortage or delay is expected, they will work with CDC to reallocate some amount of their remaining vaccine to their customers who serve high-risk patients, as well as to the high-risk customers of any non-producing manufacturer.

5) The ACIP influenza recommendations were revised this year to extend the optimal vaccination period for high-risk individuals to the end of November (see Appendix I). Health care providers should continue to offer vaccine to unvaccinated persons after November and throughout the influenza season even after influenza has been documented in the community. Influenza activity peaked during January in 5 of the last 19 years and in February or later in 10 of the last 19 years. Therefore, immunizations should continue even after November because they can still confer significant benefit in the great majority of influenza seasons. ACIP recommendations also suggest that persons planning substantial organized vaccination campaigns consider scheduling these events after mid-October, to minimize cancellations if vaccine delivery is delayed.

The new ACIP recommendations also encourage physicians to strongly consider administering pneumococcal and influenza vaccines at the same time to persons who had not previously received the pneumococcal vaccine. The target groups for these vaccines overlap considerably, and disease caused by pneumococcus and other types of bacteria can be a major complication of influenza. Pneumococcal vaccination has some value in protecting against complications of influenza, but is not a substitute for flu vaccine for several reasons: 1) pneumococcal vaccine does not protect against influenza, 2) many influenza complications resulting in hospitalization are not related to pneumococcal disease, and 3) the pneumococcal vaccine may only protect against the 10 to 25 percent of cases of pneumococcal bloodstream infections (bacteremia).

For the long-term, it is important to increase collaboration between State and local health officials and private sector vaccine distributors and providers on a routine basis. These collaborative relationships would be critical in redirecting vaccine, if necessary, during a shortage or delay in availability.

Conclusion

Mr. Chairman, it was an unusual year for flu vaccination. There were problems throughout the country caused by the supply and distribution of vaccine. CDC, and its partners, took steps to make the situation better and minimize the effects of the delays. Fortunately, the 2000-2001 season was unusually mild, which probably diminished demand for the influenza vaccine. We must anticipate that future seasons may be more severe, emphasizing the need to establish long-term solutions. CDC and its public and private sector partners will continue to work closely together to target vaccination to high risk individuals first to minimize the adverse impact of delays. As the season progresses and more information is available regarding influenza vaccine supply, CDC will provide updates at its website at www.cdc.gov.

Thank you again for your interest in this important public health issue. I would be happy to respond to any questions you may have.

Appendix I

CDC has published the Advisory Committee on Immunization Practices' (ACIP) recommendations, "Prevention and Control of Influenza" in the April 20, 2001 Morbidity and Mortality Weekly Report. (The MMWR can be found at www.cdc.gov).

The ACIP recommends vaccination for the following people who are at high risk for complications from influenza:

persons aged > 65 years;
residents of nursing homes and other chronic-care facilities that house persons of any age who have chronic medical conditions;
adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including asthma;
adults and children who have required medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppresion caused by medications or by human immunodeficiency virus);
children and teenagers (aged 6 months to 18 years) who are receiving long-term aspirin therapy and, therefore, might be at risk for developing Reye syndrome after influenza infection; and
women who will be in the second or third trimester of pregnancy during the influenza season.

In addition to these groups of individuals at high risk of complications from influenza, vaccination is also recommended for all persons aged 50 - 64 years because the prevalence of individuals with high-risk conditions in this age group is elevated, and for health-care workers and others in close contact with persons at high risk, including household members because they can easily pass infection onto high risk persons.

Last revised: September 24, 2001