Childhood Vaccines:

Ensuring an Adequate Supply Poses Continuing Challenges

GAO-02-987: Published: Sep 13, 2002. Publicly Released: Sep 17, 2002.

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Immunizations are considered one of the leading public health achievements of the 20th century. Mandatory immunization programs have eradicated polio and smallpox in the United States and reduced the number of deaths from several childhood diseases, such as measles, to near zero. A consistent supply of many different vaccines is needed to support this effort. Recent childhood vaccine shortages have prompted federal authorities to recommend deferring some immunizations and have caused states to reduce immunization requirements. At the state and local levels, 49 state immunization programs reported rationing one or more vaccines. Shortages have also prompted most states to waive or change immunization requirements for school and day care programs so that children who have not received all mandatory immunizations could enroll. Many factors contributed to recent vaccine shortages, and while these have largely been resolved, the potential exists for future shortages. On the supply side, some manufacturers had production problems, causing them to fall below their expected output, while others discontinued making some vaccines altogether. On the demand side, one manufacturer could not keep pace with the greater-than-expected demand for a new recommended vaccine. Federal agencies and advisory committees are exploring ways to help stabilize the nation's vaccine supply, but few long-term solutions have emerged. One option--expanding vaccine stockpiles--is being widely considered as a short-term strategy to help cushion disruptions in vaccine supply. Stockpiles have been used successfully to help mitigate supply disruptions in the past.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: The Food and Drug Administration (FDA) has implemented GAO's recommendation to ensure widespread distribution of compliance guidelines to vaccine manufacturers. In September 2002, GAO recommended that the Secretary of Health and Human Services direct the Commissioner of the FDA to take steps to ensure widespread distribution of all forms of compliance guidelines to vaccine manufacturers and ensure that these guidelines are kept up to date. In response, FDA made available the Compliance Program Guide for Inspections of Licensed Vaccines on FDA's web site as of May 2003, information that was previously only made available to manufacturers upon request. In addition, as of August 2004, FDA has added information about biologic product shortages, including vaccines, to its web site.

    Recommendation: To help strengthen the vaccine supply without compromising standards that ensure safety, the Secretary of Health and Human Services should direct the Commissioner of FDA to take steps to ensure widespread distribution of all forms of compliance guidelines to vaccine manufacturers and ensure that these guidelines are kept up-to-date.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: The Centers for Disease Control and Prevention has implemented GAO's recommendation to develop a strategic plan that includes steps to monitor childhood vaccine supplies in state depots.

    Recommendation: To ensure a well implemented strategy for expanding HHS' stockpiles of childhood vaccines, the Secretary of Health and Human Services should direct the Director of CDC to develop a strategic plan that addresses the operational difficulties involved. At a minimum, such a plan should include steps for monitoring childhood vaccine inventory in state Vaccines For Children depots.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: The Centers for Disease Control and Prevention (CDC) has implemented GAO's recommendation to develop a strategic plan that includes procedures for systematic interchange of information between the Food and Drug Administration (FDA) and CDC on potential childhood vaccine manufacturing interruptions. CDC reported in August 2004 that it had developed a strategic plan for the pediatric vaccine stockpile program. As recommended by GAO in September 2002, the strategic plan addresses procedures for routine communication between CDC and FDA. These include (1) the designation of primary National Immunization Program and FDA contacts, (2) procedures for safeguarding the confidentiality of information obtained from FDA, and (3) a standing request for key information from FDA regarding upcoming manufacturer inspections, results of those inspections, lot release test data, and licensing status. In addition, procedures for the exchange of information between FDA and CDC are detailed in a 3-year Memorandum of Understanding, which remains in effect until 2006.

    Recommendation: To ensure a well implemented strategy for expanding HHS' stockpiles of childhood vaccines, the Secretary of Health and Human Services should direct the Director of CDC to develop a strategic plan that addresses the operational difficulties involved. At a minimum, such a plan should include procedures for systematic interchange of information between the Food and Drug Administration (FDA) and CDC on potential childhood vaccine manufacturing interruptions.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: The Centers for Disease Control and Prevention (CDC) has implemented GAO's recommendation to develop a strategic plan that includes procedures to ensure that stockpiles of vaccines are incremental to manufacturers' normal inventory levels. As of August 2004, the CDC has developed a strategic plan for the pediatric vaccine stockpile program. The strategic plan, dated December 2003, refers to GAO's September 2002 report and states that it is critical that stockpile contracts require the separation of stockpiled vaccine from manufacturer inventories to ensure that stockpiled vaccine is distinct from manufacturer inventories and supplements rather than supplants routine vaccine production (i.e. maintenance of effort). The strategic plan also includes the specification that manufacturers must be able to report, by lot number, which vaccines are part of the CDC stockpile and which are part of normal business inventories. In addition, site visits and reviews of inventory records will be used to assess maintenance of effort on the part of manufacturers. Stockpile contracts with manufacturers will include specific language about the protocol for CDC (or its third party contractor) to conduct periodic inspections during normal business hours as well as unannounced inspections. Protocol components include: (1) provision to CDC of a list of lot numbers, storage locations, and doses included in the stockpile; (2) physical counting of doses in specified locations by CDC staff, including a random inspection of inner packaging to ensure boxes are packed as marked; (3) evaluation of storage conditions by CDC staff with specific reference to specifications published by FDA and the manufacturer of the vaccine; and (4) ability of CDC to terminate the contract as specified in the contract if stockpiled inventory is less than CDC record counts.

    Recommendation: To ensure a well implemented strategy for expanding HHS' stockpiles of childhood vaccines, the Secretary of Health and Human Services should direct the Director of CDC to develop a strategic plan that addresses the operational difficulties involved. At a minimum, such a plan should include procedures to ensure that stockpiles of vaccines are incremental to manufacturers' normal inventory levels.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: The Centers for Disease Control and Prevention (CDC) has implemented GAO's recommendation to develop a strategic plan that includes a determination of form and storage location of stockpile vaccines. The CDC reported in August 2004 that it had developed a strategic plan for the pediatric vaccine stockpile program. As recommended by GAO in September 2002, the strategic plan addresses vaccine form and storage location. The plan dated December 2003 states that (1) vaccines included in the stockpile will be in either a packaged, ready-to-ship form or a filled, unlabeled form, which requires packaging and labeling prior to shipping; (2) CDC will establish with the manufacturers multiple storage sites for each vaccine in the stockpile; and (3) provision for at least two manufacturer storage sites will be specified in the vaccine stockpile contracts.

    Recommendation: To ensure a well implemented strategy for expanding HHS' stockpiles of childhood vaccines, the Secretary of Health and Human Services should direct the Director of CDC to develop a strategic plan that addresses the operational difficulties involved. At a minimum, such a plan should include a determination of form and location of storage of the vaccine.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: The Centers for Disease Control and Prevention (CDC) has implemented GAO's recommendation to develop a strategic plan that includes specific quantities for each vaccine included in the pediatric vaccine stockpile program. GAO recommended in September 2002 that CDC develop a strategic plan that includes a timetable developed with manufacturers' input, for the purchase of specific quantities of vaccine. As of August 2004, CDC's plan, dated December 2003, includes target quantities for a 6-month supply and, based on the current estimated quantities of vaccine that manufacturers can produce for the pediatric vaccine stockpiles, CDC is requesting a 3-year funding level of $683 million to continue to expand the stockpiles from 2004 to 2006. Specifically, funds will be used to purchase 6-month national stockpiles of DTaP, Hib, hepatitis A, hepatitis B, influenza, and PCV vaccines. The combination vaccine Pediarix, containing DTaP, IPV, and hepatitis B, will also be purchased with these funds.

    Recommendation: To ensure a well implemented strategy for expanding the Department of Health and Human Service's (HHS) stockpiles of childhood vaccines, the Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention (CDC) to develop a strategic plan that addresses the operational difficulties involved. At a minimum, such a plan should include a timetable, developed with the manufacturers' input, for the purchase of specific quantities of vaccine.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: The Food and Drug Administration (FDA) has implemented GAO's recommendation to allow expedited review of vaccines under development, even in periods of non-shortage. FDA policy did not allow expedited review in such situations; thus, GAO had recommended that FDA revise its policies to allow expedited review in non-shortage periods. FDA has clarified its interpretation of the expedited review policy to implement GAO's recommendation. FDA cited, for example, the initial use of expedited approval of an influenza vaccine in August 2005.

    Recommendation: To help strengthen the vaccine supply without compromising standards that ensure safety, the Secretary of Health and Human Services should direct the Commissioner of FDA to consider revising FDA policies for fast track and priority review approval of vaccines currently under development to allow their use, even in periods of nonshortage, in cases where FDA determines that applying them would help address the unmet need of a stable and sufficient overall vaccine supply.

    Agency Affected: Department of Health and Human Services

 

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