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Factors that Result in Low Immunization Coverage

Several factors are contributing to the fact that 20 percent of American preschoolers are not receiving all needed immunizations.  These factors can be broadly described as:

  • Systemic issues including underfunded immunization programs
  • Underutilized and unevenly supported immunization registry systems among the states
  • Public misperception about the importance of timely vaccination and vaccine safety

Systemic Issues

Efforts to immunize children involve a set of complex and separate financial arrangements among federal, state, and local health agencies, as well as collaborations with public and private health care providers.  State governments have the responsibility for meeting the health needs of residents who are not served or are underserved by the private health care sector.  Each state invests in immunization programs, but no state has sufficient resources to ensure all children are immunized.  The federal government thus assists states by providing funds for vaccine purchase and infrastructure support.xxxv

Federal assistance is provided primarily through two sources: Section 317 of the Public Health Service Act, administered by the National Immunization Program within the CDC, and the Vaccines for Children (VFC) program, administered jointly by the CDC and the Centers for Medicare and Medicaid Services (CMS).xxxvi,xxxvii The Section 317 program provides funds for state immunization operational costs and many of the vaccines provided in public health clinics.  The VFC program aims to improve vaccine availability to children nationwide by providing vaccines free-of-charge to Medicaid-eligible, uninsured, underinsured, American Indian, or Alaska Native children through both public and private providers. xxxviii

Vaccine Delivery.

Over half of immunizations are paid for by the government,xxxvix but about 70 percent of vaccines are administered in private settings.xlThe VFC program and the Medicaid program provide publicly-funded vaccines primarily through private delivery.xli  Alarmingly, the IOM has found that the private contribution to this partnership may be weakening.xlii 

Most public and private health insurance includes vaccine benefits, but the scope of these benefits varies widely by insurance type and by vaccine.  To address this issue, state and federal governments have required certain types of insurance coverage for some vaccines.  However, the regulatory effort is uneven and difficult to administer.xlii  

Of growing concern is the plight of underinsured children -- those whose families have health care insurance that excludes vaccine coverage, or that charges high deductibles or copayments.  These children, largely from working families, are not eligible to receive federally-funded VFC vaccines unless they travel to a Federally Qualified Health Center (FQHC), federally-designed comprehensive health organizations serving predominantly underserved population.  Relying on FQHC limits access to many underserved children due to location or accessibility.  Underinsured children are not permitted to receive vaccines at a public health clinic, even if they visit that clinic for all of their other medical needs.  Legislation, the Children's Vaccine Access Act of 2004, has been introduced in Congress to remedy this, but has not been passed.  

Requirements under the VFC program also affect financing for some vaccines.  The VFC statute sets a limit, or cap, on prices that the federal government pays for certain vaccines (e.g. tetanus and diphtheria (Td) vaccine) that were in use prior to 1993.  The price caps are so low, however, that these vaccines were removed from the VFC program in 1998 when no vendor would bid on a contract to sell the vaccines to the federal government.  Consequently, these vaccines are unavailable for purchase under the program.

Vaccine Supply.

Closely related to vaccine financing and delivery is supply.  The vaccine supply system has experienced major changes in recent decades and many believe that the current system may be in jeopardy.  In the last 30 years, over 25 companies produced vaccines.  However, currently only five companies produce all vaccines recommended for routine use by children (and adults).xliv  Although vaccines are important disease prevention tools and have significant societal value, they often generate lower revenues than pharmaceuticals.  Vaccines must compete with other more lucrative products in a manufacturer’s portfolio.xlv

In addition, the process of developing and manufacturing vaccines is complex, expensive, and lengthy.  Research and development can take more than five years and there is a long lead time for manufacturing a single lot of vaccines up to a year.  In addition, the U.S. Food and Drug Administration’s (FDA) process for reviewing vaccines is more complex than for pharmaceuticals.  Moreover, vaccine manufacturing is more uncertain than most other pharmaceutical products.  For example, the composition of the influenza virus vaccines changes nearly every year.xlvi 

Vaccine supply has also been plagued by recent shortages that were unprecedented in scope and severity.  While temporary production problems appear to have eased, the potential for disruption remains. xlvii  Shortages, such as the one during 2001-2002 for DTaP, MMR, varicella, and pneumococcal conjugate vaccines can lead to deferral in immunization. Reasons for the recent shortages include one vaccine manufacturer’s decision to cease production of DTaP and manufacturing problems at production facilities.  In addition, an unexpectedly rapid uptake/demand for the new pneumococcal conjugate vaccine was accompanied by sporadic manufacturing problems.  Changes in recommendations regarding vaccines, including the decision to eliminate the use of thimerosal as a preservative and an expanded age recommendation for flu vaccine among adults, also led to vaccine shortages.

More recent vaccine supply issues have also occurred -- a shortage of influenza vaccine during 2003-2004.  The severe start to the flu season, and the deaths of five young children in Colorado spurred public demand for vaccine and shortages in some parts of the U.S. ensued.  In addition, shortages of pneumococcal conjugate vaccine in early 2004 developed due to production problems of the sole manufacturer. 

Link to CDC site for Vaccine Supply Updates – http://www.cdc.gov/nip/news/shortages/default.htm

Inadequate Immunization Program Funding and Vaccine Cost Increases.

Since 1999 the cost to immunize one child has tripled as new vaccines have been added to the recommended schedule.  Moreover, the cost of vaccines is projected to rise substantially over the next several years.  The current cost of the recommended vaccine series for children through age six is estimated to rise as high as $1,200 per child by 2020, due in large part to the development of important, but more expensive vaccines.xlvii 

The projected three-fold increase in immunization costs coincides with substantial pressure on federal and state budgets.  Currently, approximately 56 percent of childhood vaccine is purchased with public dollars, including federal, state and local funds; the remaining vaccine is purchased in the private sector.xlix 

The cost of fully vaccinating each child has risen dramatically with the advent of new, life-saving vaccines. 

Link to cost of vaccines chart http://www.317coalition.org/documents/moreresources05.pdf

Federal appropriation for the immunizations has not kept pace with the real costs of immunizing children  

Link to appropriations chart.   http://www.317coalition.org/learnmore/chart1.shtml

Public health departments are no longer able to immunize all children and are forced to choose between life-saving vaccines.  Link to chart file “number of children”

 

xxxv  Calling the Shots: Immunization Finance Policies and Practices.  (Washington, D.C.:  Institute
     of Medicine, 2000).

xxxvi  Ibid.

xxxvii  Congress established the Vaccines for Children Program (VFC) in 1994 to better ensure equal
     access to immunizations for all children.  The VFC program is a state-operated, federal
     entitlement program that removes vaccine cost as a barrier to immunization for poor children. 
     Over 43,000 provider sites are enrolled in the VFC program, and 73 percent of these are
     private provider sites.  The VFC program provides public-purchased vaccines to all enrolled
     providers who agree to vaccinate VFC-eligible children.

     Children from birth to age 18 are eligible for VFC if they are Medicaid-eligible, without
     health insurance, American Indian or Alaska Native.  Additionally, children with health
     insurance that does not cover vaccines are eligible if they are served through a federally     
     qualified health center. 

     From the 2003 Annual Report for the Centers for Disease Control and Prevention’s
     Immunization Program: 34.

xxxviii  Other federal programs include the Public Health Service Act 317(d) categorical aid
     program, the Maternal and Child Health Block Grant, and other, smaller programs.

xxxix  Financing Vaccines in the 21st Century: Assuring Access and Availability, (Washington,
     D.C.: Institute of Medicine, August 2003).

xl  Development of Community and State-Based Immunization Registries (Washington, D.C.:  
     National Vaccine Advisory Committee, 12 January 1999): 10.
           

xli  Ibid.

xlii  Financing Vaccines in the 21st Century: Assuring Access and Availability, (Washington,
     D.C.: Institute of Medicine, August 2003).

xliii  Ibid.

xliv  Ibid.

xlv  Strengthening the Supply of Routinely Recommended Vaccines in the United States, 
    (Washington: D.C.: U.S. Department of Health and Human Services, National Vaccine
    Program Office, January 2003).

xlvi  Ibid.

xlvii  Financing Vaccines in the 21st Century: Assuring Access and Availability, (Washington,
     D.C.: Institute of Medicine, August 2003).
           

xlviii  Michele G. Sullivan, “Public Sector Cost of Childhood Immunizations Set to Skyrocket,”
      Family Practice News: 32.12 (15 June 2002) [Anywhere from three to seven new vaccines
      are anticipated over the coming decades according to three national reports].

xlvix  Strengthening the Supply of Routinely Recommended Vaccines in the United States, 
     (Washington: D.C.: U.S. Department of Health and Human Services, National Vaccine
     Program Office, January 2003).