The shortage of flu vaccine in the fall of 2004 renewed discussion of the fragility of thenation's system for providing this potentially life-saving product. Some have expressed concern thatthis situation bodes ill for national preparedness for an influenza pandemic or a large-scalebioterrorism event. This report will describe the current system of flu vaccine production anddelivery, the causes of supply problems, and options for improvement. Flu Vaccine Shortage in the 2004-2005 Season

		Government and Corporate Actions

On October 5, 2004, Chiron (pronounced KÄ«Ì-ron), a California-based biotechnologycompany, notified U.S. health officials that British regulatory authorities had suspended productionof influenza ("flu") vaccine in its plant in Liverpool, England, due to vaccine safety concerns. Theplant was slated to provide between 46 million and 48 million doses of injectable flu vaccine(FluvirinÂ®) for the U.S. market for the imminent 2004-2005 flu season, almost half the plannednationwide supply of 100 million doses. The announcement of Chiron's suspension prompted CDC and its Advisory Committee onImmunization Practices (ACIP) to re-define the groups most at risk (enumerated in Table 2 ), to begiven priority for the available vaccine doses. CDC also activated its Emergency Operations Centerto coordinate nationwide tracking of available vaccine doses, high-priority individuals who mightneed 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 determineif any of the affected Chiron vaccine lots could be salvaged, but announced on October 15, 2004 thatnone of the vaccine was safe for use. The FDA also sought to identify additional sources of vaccinefrom other manufacturers, domestically and abroad. States responded to the shortage by launching plans to locate and re-distribute or ration dosesof vaccine, and by pursuing widespread reports of price-gouging. a. Some in Congress,concerned that states may not always be able to respond effectively, have asked aboutrelevant federal authorities. Since the shortage was announced, several vaccinemanufacturers expressed interest in entering the flu vaccine market. Congress added flu vaccine to the VICP list in October 2004, inthe American Jobs Creation Act of 2004 ( P.L.108-357 ). The response of the public to government recommendations during the 2004shortage is illustrative. Actually, theshortage of flu vaccine illustrates two serious challenges that the federal governmentfaces in a public health emergency. Law and tradition place much of theresponsibility for preventing or managing the shortage either with the states, or withthe private sector, and the threshold over which the federal government would wrestcontrol from either appears high. A number of bills were introduced before the 2004-2005 shortage was announced, some in response to flu vaccine problems during the2003-2004 season. Senate Special Aging Committee, hearing on Influenza and the Elderly , September 28, 2004. Sloan et al., "The Fragility of the U.S.
On October 5, 2004, Chiron (pronounced KÄ«Ì-ron), a California-based biotechnologycompany, notified U.S. health officials that British regulatory authorities had suspended productionof influenza ("flu") vaccine in its plant in Liverpool, England, due to vaccine safety concerns. Theplant 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 andPrevention (CDC) and its Advisory Committee on Immunization Practices (ACIP) to re-define thegroups most at risk, to be given priority for the available vaccine doses. CDC coordinatednationwide tracking of available vaccine, high-priority individuals who might need it, and infectionssignaling the start of the winter flu season. The Food and Drug Administration (FDA) sent a teamto the Liverpool plant to determine whether any of the Chiron vaccine lots could be salvaged (theylater determined that they could not) and sought additional sources of vaccine from othermanufacturers, domestically and abroad. States launched plans to locate and re-distribute or rationvaccine, and responded to reports of price-gouging. The response of local, state, and federalagencies was limited because most of the U.S. flu vaccine market is in private hands.
Several bills were introduced in response to the shortage, and proposals introduced earlierin the 108th Congress, in response to flu vaccine supply problems during the 2003-2004 season,received renewed attention. Two hearings on influenza vaccine were held immediately prior toannouncement of the shortage, indicating Congress's ongoing interest in this issue. Additionalhearings were held after the shortage was announced. Congress also passed (in P.L. 108-357 , theAmerican Jobs Creation Act of 2004) a provision adding flu vaccine to the National Vaccine InjuryCompensation Program (VICP), and provided $100 million in FY2005 funding for influenzapreparedness, which could be used to purchase flu vaccine.
The shortage illustrates the challenges that the federal government faces in responding topublic health threats. Much of the responsibility for preventing or managing the shortage rests withthe states or with the private sector, and the threshold over which the federal government wouldwrest control from either appears high. As a result, the federal government may appear disorganizedor unresponsive. The shortage also raises questions about the role and effectiveness of governmentin rationing a scarce health resource.
As communities across the country saw long lines of sick and elderly citizens waiting in vainfor flu vaccine, and concerns about the supply for the 2005-2006 season emerged as well,policymakers asked why the 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 forpreparedness for an influenza pandemic or a large-scale bioterrorism event. This report will describethe system of flu vaccine production and delivery, the causes of supply problems, and options forimprovement. It will be updated as circumstances warrant.