Developing a Comprehensive Public Health Approach to Influenza

  • Date: Dec 14 2005
  • Policy Number: 20052

Key Words: Immunization, Infectious Diseases

Vaccination Background and History

In the United States, influenza is responsible for more than 200,000 hospitalizations and 36,000 deaths averaged each year.1 Widespread use of influenza vaccine among persons targeted for immunization can reduce this burden. The Government Accountability Office (GAO, formerly the General Accounting Office) previously concluded that problems at one or more manufacturers of influenza vaccine could significantly upset the production and annual delivery of U.S. vaccine, as only two suppliers, Aventis Pasteur and Chiron Corporation, provide the country with over 95 percent of its total supply.2,3 Further, the number of companies selling influenza vaccine in the United States has steadily diminished since 1976.

Inactivated influenza vaccine, administered by injection, is the principal influenza vaccine currently in use. The first live attenuated influenza vaccine, delivered
intranasally, was approved by the Food and Drug Administration in June 2003 and has limited indications.4,5 Despite the recommendation of the Centers for Disease Control and Prevention that approximately 185 million Americans fall into at-risk and other target groups that should receive inactivated influenza vaccine annually, vaccination against influenza during recent flu seasons has fallen short when less than half that number of Americans were vaccinated.6 Broad vaccination against seasonal influenza has become problematic because the vaccine supply of the United States has not been adequate due to manufacturing, safety and quality control difficulties at vaccine manufacturing plants of companies with a contract with the United States Department of Health and Human Services to produce vaccine for domestic use.7

Current Infrastructure to Address Influenza Vaccine Shortages

The delivery system for influenza vaccines in the United States is highly decentralized. Vaccine distribution occurs primarily in the private sector with little influence by state and local health departments on actual vaccine ordering, delivery or administration. The vaccine manufacturers determine the number of vaccine doses to be produced each year by attempting to anticipate demand. This decision is often based upon prior vaccine usage coupled with any changes in vaccine recommendations (e.g., universal vaccination of children 6-23 months of age). The companies may consult CDC; however, CDC has no authority to require a set amount of production. CDC's major influence is through recommendations for use by the Advisory Committee on Immunization Practices. CDC can, however, contract for production of influenza vaccine reserves.

This lack of centralized oversight has led to difficulty in doing advanced planning for or providing advanced direction about redistribution when there is a shortage of inactivated influenza vaccine. Further, no current mechanism exists for the federal government to ensure that immunization priority is given to individuals in identified high-risk groups or that vaccination stocks are equitably distributed. In times of shortages or "spot" shortages, particularly those entities that do not order vaccine in mass quantities local and state health departments and physician's offices have had difficulty acquiring influenza vaccine.8

As a first step, in 2001, the GAO recommended the CDC, to better prepare for influenza vaccine shortages, should formulate voluntary guidelines for vaccine distribution in the event of a future vaccine delay or shortage.9 Despite the efforts of CDC to intervene in the national crisis, the FDA on Oct. 9, 2004, invoked the "emergency medical reasons" provision (Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act), which allows for a hospital or health care entity to redistribute influenza vaccine to alleviate vaccine shortages.10 Without centralized federal oversight, there is no guarantee that the redistributed vaccines will reach those members of high-risk groups most in need of the vaccine.

Mechanisms to Ensure Vaccine Supply and Distribution

Manufacturing inactivated influenza vaccine relies on growing viruses in millions of fertilized chicken eggs and generally takes six-to-eight months to complete. This causes manufacturers to predict demand and federal and global officials to decide which three strains to include in the vaccine far in advance of the flu season. The result has been uncertainty as to whether the annual influenza vaccine supply will meet the demand for the vaccine.11Also, this lag time in manufacturing makes the supply of influenza vaccine for U.S. distribution vulnerable to antigenic shift and antigenic drift.12 This, along with unpredictable demand and a decentralized distribution system, complicates the ability of the United States to protect itself against epidemics and a future influenza pandemic.

The American Public Health Association has approved several policy resolutions (83-02; 87-06; 89-06; 91-02; and 2000-23) that address the immunization of children and adults and provide for their protection from all vaccine-related reactions. The Association is supportive of the decision to include influenza vaccine in the federal Vaccine Injury Compensation Program, retroactive for eight years, which parallels the conclusions of APHA policy 83-02.

Current U.S. Capacity to Respond to Pandemic Influenza

The National Strategy for Pandemic Influenza and the HHS Pandemic Influenza
Plan focuses on assuring and expanding influenza vaccine production capacity; increasing influenza vaccination use; stockpiling influenza antiviral drugs in the Strategic National Stockpile (SNS); enhancing U.S. and global disease detection and surveillance infrastructures; expanding influenza-related research; supporting public health planning and laboratories; and improving health care system readiness at the community level.13,14

Although the HHS plan defines the roles of federal, state and local health and hospital officials and vaccine-producing companies during pandemic situations, neither the plan nor the National Strategy addresses the inadequacy of resources of state and local health departments and governments for fulfilling their assigned roles. Although the plan calls for widespread vaccination of individuals against pandemic flu, it does not include a federally funded compensation program for those who become ill or are injured, disabled or die as a result of receiving the vaccine.

Therefore, the American Public Health Association:

  1. Encourages the allocation of sufficient financial and human resources at local and state public health agencies and hospitals to conduct the planning and response necessary to respond to the influenza vaccine shortage and the events that may follow it;
  2. Encourages the promotion of a single public health voice in the United States on health education and communication strategies addressing, at a minimum, the organization of medical care services; the role of employers; and recommendations about preventing infection, actions by those infected and recommendations to providers during a shortage of influenza vaccine and an influenza outbreak;
  3. Affirms that CDC, as it is on other issues including smallpox and anthrax, should be the lead federal agency on issues related to domestic preparedness for and response to influenza, and should have wider authority to plan for a national response to the recurrent flu epidemics;
  4. Urges CDC to formulate guidelines for vaccine distribution in the event of a future vaccine delay or shortage that include evidence-based prioritization of high-risk groups and a strategy to ensure that smaller purchasers such as physician offices and state and local health departments have priority in receiving the vaccine;
  5. Strongly supports efforts by Congress to increase annual appropriations for the
  6. 317 discretionary grant program, to increase the capacity of CDC's National
  7. Immunization Program to fund educational campaigns to increase the awareness of influenza and correct misconceptions about the disease, and local and state activities to build the infrastructure necessary to vaccinate high-risk adults against influenza;
  8. Urges public health officials to obtain sufficient influenza vaccine supplies from other countries that have it available;
  9. Calls for the allocation of new and additional resources to the Center for
  10. Biologics Evaluation and Research of the FDA to ensure the center has sufficient capacity to provide guidance to vaccine-producing companies entering the U.S. market; administer fast-track reviews of companies producing influenza vaccine who seek to enter the US market; and effectively monitor the influenza vaccine manufacturing process to ensure the safety of the vaccine and to prevent future shortages due to safety and quality control issues from occurring;
  11. Urges the U.S. government to examine the effects of and consider increasing incentives for pharmaceutical companies to invest in the research, development and production capacity of influenza vaccine, including the establishment of a federal influenza vaccine buyback program which guarantees sufficient supply;
  12. Calls upon Congress and the president to support the establishment of a federal vaccine purchase program for uninsured adults, including those for whom influenza vaccine is recommended, modeled after the Vaccines for Children program;
  13. Encourages Congress to appropriate additional resources to research activities to develop new influenza vaccines that would work towards a production process that is faster and vaccines that are more likely to be well-matched to the influenza viruses in circulation, including but not limited to researching the effectiveness, safety and cost of cell culture influenza vaccines;
  14. Urges Congress to provide sufficient resources to state and local governments and health departments, hospitals and laboratories to prepare for influenza epidemics and pandemics;
  15. Stresses the need for revision of the HHS Pandemic Influenza Plan to delegate control of distributing influenza vaccine to federal, state and local officials to ensure that those most at-risk receive the vaccine during pandemic situations;
  16. Encourages the resources necessary for and the development of local and regional Pandemic Influenza Response and Preparedness Plans that specify actions that local public health agencies, laboratories and hospitals should take in the event of an influenza outbreak;
  17. Recommends that a federally-funded compensation program be established for those who become ill or are injured, disabled or die as a result of receiving the pandemic influenza vaccine; and
  18. Encourages an international effort, in collaboration with other donors and the
  19. World Health Organization, to produce and provide flu vaccine and personnel for those countries unable to vaccinate those at risk in their countries.


  1. Heinrich J: Infectious Disease Preparedness Federal Challenges in Responding to Influenza Outbreaks. United States Government Accountability Office, September 28, 2004.
  2. General Accounting Office. Flu Vaccine Supply Problems Heighten Need to Ensure Access for High-Risk People. May 2001.
  3. Heinrich J: Infectious Disease Preparedness Federal Challenges in Responding to Influenza Outbreaks. United States Government Accountability Office, September 28, 2004.
  4. Centers for Disease Control and Prevention. Interim Influenza Vaccination Recommendations 2004-2005 Influenza Season. October 5, 2004.
  5. United States Food and Drug Administration. First Nasal Mist Flu Vaccine Approved. June 17, 2003.
  6. Harper S et. al: Prevention and Control of Influenza Recommendations of the Advisory Committee on Immunization Practices. MMWR. 54(RR08). July 29, 2005.
  7. United States Food and Drug Administration. 2004 Chiron Flu Vaccine Chronology. October 16, 2004.
  8. Centers for Disease Control and Prevention. Questions & Answers: Vaccine Supply and Prioritization Recommendations for the U.S. 2005-06 Influenza Season. December 8, 2005. Accessed online December 12, 2005, at http://www.cdc.gov/flu/about/qa/0506supply.htm.
  9. Heinrich J: Flu Vaccine Steps Are Needed to Better Prepare for Possible Future Shortages. United States General Accounting Office, May 30, 2001.
  10. Centers for Disease Control and Prevention. FDA Authorization of Influenza Vaccine Redistribution: Level 3. October 9, 2004.
  11. Heinrich J: Infectious Disease Preparedness Federal Challenges in Responding to Influenza Outbreaks. United States Government Accountability Office, September 28, 2004.
  12. Treanor J: Influenza Vaccine Outmaneuvering Antigenic Shift and Drift. New England Journal of Medicine 2004; 350 (3).
  13. United States Department of Health and Human Services Pandemic Influenza Plan. November 2005.
  14. National Strategy for Pandemic Influenza. November 2005.

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