Influenza Vaccine Shortages and Implications
Publication Date: October 2004
Publisher: Library of Congress. Congressional Research Service
Author(s):
Research Area: Health
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Abstract:
On October 5, 2004, Chiron, a California-based biotechnology company, notified U.S. health officials that British regulatory authorities had suspended production of influenza ("flu") vaccine in its plant in Liverpool, England, due to vaccine safety concerns. The plant was slated to provide between 46 million and 48 million doses of flu vaccine for the U.S. market for the imminent 2004-2005 flu season, almost half the expected nationwide supply.
The announcement of Chiron's suspension prompted the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP) to re-define the groups most at risk, to be given priority for the available vaccine doses. CDC activated its Emergency Operations Center to coordinate nationwide tracking of available vaccine doses, high-priority individuals who might need them, and infections signaling the beginning of the winter flu season. The Food and Drug Administration (FDA) sent a team to the Liverpool plant to determine if any of the affected Chiron vaccine lots could be salvaged (they later determined that they could not) and sought to identify additional sources of vaccine from other manufacturers, domestically and abroad. States launched plans to locate and re-distribute or ration doses of vaccine, and responded to widespread reports of price-gouging. The response of local, state and federal agencies was limited because most of the U.S. flu vaccine market is in private hands.
Some members of Congress introduced legislation in response to the shortage, or pointed to legislative proposals introduced earlier in the 108th Congress in response to flu vaccine supply problems during the 2003-2004 season. Two hearings on influenza vaccine were held immediately prior to announcement of the shortage, indicating Congress's ongoing interest in this issue. An additional hearing was scheduled and held after the shortage was announced. Congress also passed (in P.L. 108-357, the American Jobs Creation Act of 2004) a provision adding flu vaccine to the National Vaccine Injury Compensation Program (VICP).
The flu vaccine shortage illustrates two serious challenges that the federal government faces in responding to public health threats. Law and tradition place much of the control of the current situation either with the states, or with the private sector, and the threshold over which the federal government would wrest control from either appears high. Free market forces operate, and the public health system responds in a decentralized fashion. As a consequence, federal efforts may seem disorganized, and the federal government may appear unresponsive.
As communities across the country saw long lines of sick and elderly citizens waiting in vain for flu vaccine, policymakers asked why the national system to provide this potentially life-saving product was so unreliable, and what could be done about it. Some have expressed concern that this situation bodes ill for national preparedness for an influenza pandemic or a large-scale bioterrorism event. This report will describe the current system of flu vaccine production and delivery, the causes of supply problems, and options for improvement. It will be updated as circumstances warrant.