Summary
Until the 2000-2001 flu season, the production and the distribution of flu vaccine generally went smoothly. In the fall of 2000, however, stories began to circulate about delays in obtaining flu vaccines. GAO reviewed (1) the circumstances that contributed to the delay and the effects the delay had on prices paid for vaccine, (2) how effectively current distribution channels ensure that high-risk populations receive vaccine on a priority basis, and (3) what the federal government is doing to better prepare for possible disruptions of influenza vaccine supply. GAO found that manufacturing difficulties resulted in an overall delay of about 6-8 weeks in shipping vaccine to most customers and a temporary price spike. Manufacturers experienced unprecedented problems growing a new viral strain, while two of four manufacturers halted production--one permanently--to address safety and quality control concerns. There is currently no system to ensure that high-risk patients have priority when the supply of vaccine is short. Although the federal government has no direct control over how influenza vaccine is purchased and distributed by the private sector and state and local governments, the Department of Health and Human Services (HHS) has several efforts underway to help cope with future influenza vaccine shortages and delays. For example, the Centers for Disease Control and Prevention (CDC) revised guidelines to extend the recommended timeframe for receiving immunizations. CDC is also helping to bring together manufacturers, distributors, providers, and others in the private and public sectors to explore ways to improve distribution to high-risk individuals.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change
from "In process" to "Implemented" or "Not implemented" based on our follow up work.
Director:
Team:
Phone:
No director on record
No team on record
No phone on record
Recommendations for Executive Action
Recommendation: To prepare for potential delays or shortages in flu vaccine, the Secretary of Health and Human Services should instruct the Director of CDC to assess the relative success of its past outreach and education efforts and identify those means that are most effective in changing behavior to meet public health priorities. When appropriate, these means should be used as the primary method to educate flu vaccine providers and the general public well before the start of the traditional fall vaccination period.
Agency Affected: Department of Health and Human Services
Status: Implemented
Comments: HHS advised GAO that they have completed an assessment of education efforts.
Recommendation: To improve response to future vaccine delays or shortages, the Secretary of Health and Human Services should instruct the Director of CDC to continue to take a leadership role in organizing and supporting efforts to bring together all stakeholders to formulate voluntary guidelines for vaccine distribution. Specifically, in formulating guidelines for getting vaccine to high-risk individuals first in times of need, work with stakeholders to pursue the feasibility of steps that showed promise in the 2000-01 flu season.
Agency Affected: Department of Health and Human Services
Status: Implemented
Comments: HHS advised GAO that guidlines have been prepared for upcoming flu season; such guidelines were published by CDC.
Recommendation: To maximize use of federal resources, the Secretary of Health and Human Services should instruct the Director of CDC to work to compliment the Health Care Financing Administration's (HCFA) ongoing activities to improve pneumococcal immunization rates among the Medicare population and focus CDC's funded efforts on increasing pneumococcal immunization in the high-risk non-Medicare population.
Agency Affected: Department of Health and Human Services
Status: Implemented
Comments: HHS informed GAO of steps taken to improve coodination.
