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Senators Take a New Look at the National Immunization Program

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Senator Kennedy (D-MA) opened the Health, Education, Labor and Pensions Committee November 27 hearing on the readiness of the National Immunization Program for handling "new public health challenges" sounding a familiar note.  "Our concerns about bioterrorism have also reminded us of the overall importance of immunization, one of the great public health victories of the 20th century."  "We must be vigilant, however, to preserve these successes.  If we fail to appreciate the value of vaccines or become complacent in our immunization efforts, we could witness sudden new epidemics.."   Kennedy then turned over his chairman's gavel to Senator Reed (D-RI).  Reed has been a dedicated immunization proponent in the Senate who has sponsored legislation broadening access and increasing federal funding. 
      Dr. Walter Orenstein, director of the Centers for Disease Control's National Immunization Program (NIP), testified.  Orenstein reported that the program is "well-poised to face the challenges of the 21st century," though "challenges remain."  He noted the outstanding immunization achievements of the 20th century, including:
 

• Reduction in the annual reported cases of diphtheria, measles, mumps, rubella, congenital rubella syndrome, and Haemophilus influenzae type b (Hib) by over 99 percent since these vaccines were made available.
• A greater than 100 percent increase in childhood immunization coverage from 1991, when only 37 percent of U.S. children received a combined series of four doses of DTP, three doses of polio, and one dose of measles-mumps-rubella (MMR) vaccine, to 2000, when the coverage level for the series plus three doses of Hib, was 76 percent.
• A more than 99 percent decrease in global polio incidence from 1988, when there were 350,000 cases, to the year 2000, when there were fewer than 3,000 cases. 

Dr. Orenstein described six challenges to the National Immunization Program: (1) a fragile supply of vaccines, (2) increased vaccine costs and gaps in paying for them, (3) stresses on local and state health departments to provide the "infrastructure"-supply, distribution, service delivery, education, disease surveillance, record-keeping; (4) concerns about adverse reactions to vaccines requiring more research, evaluation and treatment; (5) low adult immunization rates and (6) improving global immunization. 
      CDC is addressing several of these challenges by cooperating in studies conducted by outside groups.  For example, CDC awarded the Institute of Medicine a contract to develop a study on vaccine financing in the United States, which is due to be published in April of 2003.  And CDC is cooperating with the General Accounting Office, an arm of Congress, in studying vaccine shortages. 
      More immediately, CDC has been conducting projects to study and address vaccine risks.  It is continuing to study what are adverse events that result from vaccines, versus adverse events attributable to other causes; what is the magnitude of risk of vaccine-related adverse events; who is at greatest risk of suffering adverse events and how are they best treated. 
      Senator Judd Gregg (R-NH), ranking member of the Committee, asked Orenstein why so few manufacturers produce vaccines.  Is it liability concerns?  Orenstein answered no, the Vaccine Injury Compensation Program eliminated the liability concerns, but the research and development costs are very high.  Senator Kennedy asked if we need a National Vaccine Authority.  Dr. Orenstein responded that the National Vaccine Advisory Committee is already in place and doing the job.  Senator DeWine (R-OH) asked what the federal government should do to solve flu vaccine shortages.  Orenstein said CDC is recommending prioritizing delivery according to risk.  Senator Jeff Bingaman (D-NM) wanted an explanation for state disparities in immunization rates.  Dr. Orenstein suggested they are caused by disparate delivery systems.  Bingaman commented that in the same Albuquerque newspaper article on a shortage of diphtheria-tetanus vaccine to immunize 11-15-year-olds, the reporter noted there'd been no cases of tetanus in the area in 10 years.  What are the priorities?  Orenstein answered that tetanus is not contagious; diphtheria is, and that the top priority is disease surveillance. 
      Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) testified.  He was asked to provide the status of vaccine research at NIH.  His agency conducts research leading to improving existing vaccines and developing new ones, including research on potential agents of bioterrorism. 
      Fauci, echoing Orenstein and Kennedy, said, "Vaccination has been recognized as the greatest public health achievement of 20th century.  Without question, vaccines have been our most powerful tools for preventing disease, disability and death and controlling health care costs."  NIAID's role includes conducting research in collaboration with industry and academia and transferring the technology to the private sector for commercialization.  NIAID also supports research that might not prove lucrative to private industry.
      Fauci mentioned the Dale and Betty Bumpers Vaccine Research Center at NIH, dedicated to finding new vaccines.  One study currently underway at the Center is testing a new DNA-based HIV vaccine on humans.  NIAID research support led to the licensing of Haemophilus influenzae type b (Hib) vaccine for children in 1987 and for infants in 1990, resulting in a 99 percent decline in Hib, which was the leading cause of childhood bacterial meningitis and postnatal retardation. 
      NIAID still confronts the challenge of developing a safe vaccine against "the three greatest microbial killers worldwide: HIV/AIDS, malaria, and tuberculosis."  And now it has developed a smallpox vaccine research agenda to respond to both immediate and longer-range scenarios.  NIAID is working with the Defense Department "to support the development of the next generation of anthrax vaccines." 
      Senator Frist (R-TN), a heart-lung surgeon who has taken the lead in much of the bioterrorism response in Congress, asked Dr. Fauci a series of questions about vaccine supply.  What are the federal agencies doing to anticipate shortages?  Frist partially answered his own question here by noting that when passing the Children's Health Act last year that included reauthorization of the National Immunization Program, the Committee requested a Government Accounting Office report on trends in vaccine manufacturing so that the problem could be diagnosed and fixed.  Are long-term contracts with manufacturers necessary to maintain adequate supplies?  Yes they are.  Is the private sector an important player?  Yes.  Senator Clinton (D-NY) was the last to question Dr. Fauci.  Do we need an increased federal role and more federal funding?  Yes.
      Dr. Ed Thompson, Mississippi State Health Officer, testified on behalf of the Association of State and Territorial Health Officers.  He noted that he was speaking in the Dirksen Senate Office Building, which adjoins the Hart Senate Office Building, which has been closed since September 11 because of anthrax-contaminated mail.  "Yet in this room, there are also bacteria that can cause disease and death: some of us carry in our noses or throats Bordetella pertussis, which causes whooping cough.  Others carry Neisseria meningitides, which causes an often fatal form of meningitis."  "Our national attention is riveted by 11 cases of inhalational anthrax, with a case fatality rate of 45 percent.  Yet every year we have three to six thousand cases of Streptococcus pneumoniae meningitis, with a case fatality rate of 30 to 80 percent, and we have, and do not use, vaccines that can prevent most of them."
      "From ASTHO's perspective there are two key pillars of our immunization system that are especially cracked and in danger of crumbling: vaccine availability and the public health infrastructure."  The pneumococcal conjugate vaccine to prevent meningitis, pneumonia, blood and ear infections is very costly, and CDC is not adequately funded to provide adequate supplies.  Not only are states under-funded.  They are also under-supplied, forcing changes in routine vaccine recommendations.  The long-term effect of these changes is often habit-forming.  [This has been the case with Hepatitis B vaccine that was temporarily not recommended at birth.  While the recommendation was restored, the uptake has been slow.]
      One of the glaring holes in immunization programs is inattention to adult immunization.  Thompson reported that of the 64 CDC-funded immunization programs in all states, territories and some cities, only 43 have a coordinator of adult immunization activities.  "We should note that if and when a decision is made to immunize some or all of our population against smallpox, it will be state and local health departments that will organize, coordinate, and carry out these efforts."  Senator Reed asked Dr. Thompson about Mississippi's immunization registry.  Thompson said it's been in use for a long time, but that the interface between private provider offices and public health is "tough."  Mississippi relies on phones and bar codes for registry data.  "You get technology by paying for it."
      Betty Bumpers, co-founder of Every Child By Two, testified for the organization (click here to view testimony).  Asked to address what's working and what could be improved in the National Immunization Program, Bumpers, like Thompson and a few Senators, rued the episodic nature of attention to immunizations both in Congress and the general public.  The federal and state funding waxes and wanes, and health departments struggle to get the job done.  She is particularly concerned about the fits and starts in developing statewide immunization registry systems.  Since registries have proven themselves so useful in aiding immunization, why has it taken so long and cost so much to develop a system that is so uneven?  And in the development of new health information systems to answer  bioterrorist strikes, are we sure that the advances made in registry development are getting incorporated into whatever new systems we produce?  Bumpers seeks more accountability from CDC, and suggests one way to achieve it is to tie state grant funding to evidence of progress.  That way CDC, Congress and the public can rest assured that we are not throwing good money after bad.