Flu Vaccine Mary K. Feeney GENERAL OVERVIEW ‘The 2004-2005 U.S. Influenza Vaccine Shortage Inu, or the fy, causes oughly 36,000 deaths and 200,00 hospital Ttatons annually inthe United Stats and cost the American economy emwcun $11 bilion and $18 bili cach year (18, pg. 1. The primary Wethod for preventing influenza ihe fa vaccine, whic generally avail Thien aware of setngs, including cis, hospital schools, work ‘laces nd eter convenient Hoetions, The vacine s gpcalydsibuted PaO ctober and November in anticipation of de winter fu season, which vaualy begins in late November and peaks in February. For the 200% O05 fs season, the Centers for Disease Control and Prevention (CDC) retomumended shat as many as 185 milion Americans receive 2 fi sho. ‘Rosong those 188 rion, almost half (90 milo ae considered high AA id pp. 2 #1). "The highessk popolacion includes aduls 65 and ‘le infas 6 t9 23 months old, pregnant women, health eae workers Giese whe cre far eildeen under € moaths old, and people with com semnaed imanune Systems or chronic ese ch asthma ang cer en and gti Sion #14; #19) Ti regent years Amencans have faced fs vee shortages on m= ple occasions For example, ae he begining of the 2000-2001 fu season, ae eit for the racene oustripped supply when problem developing 2 seer sen and safety and quality eonrolssuesreporany delayed Fe ae civeny by 6-8 weeks [#10, #18), The redoced sopply sulted in48 Public Policy an uneven dstrbation of avaiable vacines and sharp price increases 35 the cost of fa shots more than doubled frm the previous seson [418 pis 2), In 2001-2002, three manuficares produced 87 milion dese, of Sthich almost one-third were not rable whea demand forthe vaccine peaked. The folowing yesr suply excoded demand when only 87% of the 95 millon doses produced were purchased. Tn 2008-2004, demand ‘ceeded sippy when 4 milion doses wer discarded and 87 milion doses Steve inappropriats fr hac yours fo stain [8 #18; #1), The Institute of Medicine COM notes that these recent shortages have “highlighted the fragility of vaccine supply which saree compli= cated by declining finanial incentives to develop and produce vaccines [n2, pa The high isk marke, longterm exorbitant production costs, til low profit margiss have redvced the number ofwaceie manafsrae= {sin the United States from move than 25 compas 30 years ago to only 5 in 2003 #22, pg. "The production of the a vaccine a sky and long-term venta for 1 Opening new facilities en take Sor more years due to high Federal Drug Administration (FDA) quality standards Producing the a vaccine takes 6 t9 8 months, andthe formula ean= ot be altered once production has begun. 3. Manufactarers must reformulate the vaccine anally 0 adress new Inlucnes stave, preventing sanficarers fom feusng excess Sap ples rm the previous season. 4. Theres emensve risk associated with predicting supply and demand for ihe fr racine because there no mechanism for predicting the market, Demand and sopply inthe ft vaccine market tendo be fickle, shi ing fom year to year or month to moat based onthe severity ofthe {Bu season, public health efforts to promote vaccination, and the Hin= ing ofrctne aalbiliy. 6. The profic main for producing the fla vaceine i law because vac: ines ate sold ata low price relative othe high tm, rs and est of producing safe and efficient vaccines. Producing vaccines spatially mprotable in comparison to deve fing phacmacetid rags that pets purchase on dy basis raeipitating Factors in the 2004-2005 Flu Crisis By 2004, rwo companies, Aventis and Chiro, produced ail ofthe la vac Shae forte Une Sates and hopes 0 provide 100 million doses for the 2004-2005 fu season In Asgust 2004, Chon, a Cai pny, announced tothe FDA and the Medicines and Hal Regulatory Agency (MIRA) in Britain thatthe 8 milion doses produced at Chiron’ plant_in Liverpool, England, had been contaminated Concerns about quality and safety atthe Liverpool plat emerged a eatly ‘2003 following an FDA inspection. Ae that tate, however, the FDA ‘Mlowed Chiron to voluntarily fx the problems and, bse on reasurances from Chiron, the U.S. government believed the bacterial contamination issue would be resolved. The FDA proceeded to communicate with Chiron via rer, e-mails and phone all while the MEIRA took a more proactive approach cluding inspections of che plane (9 Th October 2004, to the surprise ofthe US. government, the MIRA suspended Chiron ieense and closed the Liverpool plant, Dr. Schaffer ff the National Vsecine Advisory Commitee sited that, “we have been Feassured on 9 cegulr bisis” that the contamination at Chiron was not foing co be a major problem (29, pg 3) Tommy Thompson, Secretary of Fett and Human Services, reported that we bad no idea" this uspen- sion would accur (#28, pa. 1} By mid-Ocwbe, the FDA confirmed shat fone ofthe Chiron victine could be salvaged Media frenzy and public outrage followed the announcement shat Americans would not receive almast half ofthe expected 100 milion doses ofthe fla vacine. Acne che nation long lines formed onside health cin ies while others rushed ro Canada fr de fu shot, As withthe 2000-2001, ‘eccne shortage, when demand surpassed sappy, reports of pice gouging Tnmeditely appeared. For example, «pharmacist was reportedly offered 1 doses thacuvaly cost $57 for $700 (#2). Meanahile Shore Memorial, Hospital in New Jersey was offered 8,000 doses, which had been illegally Smugeled into the United States, tthe pice of $0 exch (03), Besides price gouging, ina more excreme cat, 620 vaccine doses were stolen from 1 Colorado penance (5) Thais othe sing cot of fa shots, dtibating available vecines quickly became a problem. The distribution ssues came as no surprise to Federal ofcials o heatheare workers who have long known about the Frgily of the US. vaceine market Following the 2000-2001 vaccine shore the GAO published a report outlining esses related to vaccine Shortages and recommending policies to preven future problems. The eps prinary concern waste here “ho sjscem to enone that high Fk people have proiy wien the supply of vaccine is shor” (18, pg 3 Because the production, se, and distibrson of the Au vaceine ate private enterprise, the aalable 2004 vaccine supply was unevenly ds Uributed throughout the nation. "Those health fetes cht ordered the ‘nceine fom Chiron were left with no doses, while others, supplied by [Avent had thie ene order filled immediate, Distribution is based on type of healthcare provider, not onthe level of Zk aznong patiens. Public50 Public Policy fics know very Tiel about how fl vaccine supplies are shipped and to thom, aking i ificul to impossible for the government co intervene Inthe tsebution ofthe availble vaccine prodoced by Aventis “The CDC responds to distribution concerns by recommending that ‘ealthcare provers ration the vacine to high-risk patients, Flowevet, nue the CDC lacks the authority to inervene in the distribution proces of enforce guidelines, the recommendation left states, healtheare ever, county health department, and doctors to determine how to dis ‘ligt dhe vccine: Many fy shot providers ase healthy ada to woh (inty pose up the vaccine, leaving avaiable supplies forhigh-rick individu Sk In Marjland, the state immnizaion center operated as vaccine broker to ensure that public health agencies received! 100% oftheir orders. ‘Meanie, in Virginia, the sate divided avaiable vaccines proportion. tip to consis data (925. In rire eases, soch as in the Disiet of ‘Columbia, fu shots were stricly reserved for high-risk patients (#24, However in general, chy and sate ofcals did aoc deay the vaccine to ely people who wanted Treas wo price gouging and distribution issues, the CDC erated panel to investigate the ether of disebuting the fu vaccine, In addition, ‘Nfoera! sk force dhe Fle Action Tsk Force, was convened to manage the fede vacine supply, coordinate efor and prevent price googing {#21}, By mid-October federal agencies began dsebuting their store of {hs doses high-risk ares and within 1 week ert of 3.2 milion doses, Fd been sent to high-priority groups. That same week many hospital tegen chang fla vaceite supplies, Te federal government also diverted Sonal 38,000 doses rom federal employees and dhe military tothe nik ean population. “Gace twas confirmed thatthe entre Chison supply was unsalvage- se: the federal government began to lok overseas for adltional doses Scereary Thompson announced that Aventis woud have 26 million more dower of the ta vaccine by January 2008. The United States also began "egotsting wth am ID Biomedical plant in Canada and GlaxoSmithKline ‘Sennuny to parchaseadlitianal doses. Uaforeunately, those purchases “hore dele they awaited FDA approval By carly Detember, President Dosh confioed thatthe United Sestes would purchase 1.2 milion doses ‘hom Gerany (82) The FDA required patients to sig consent form ‘rhe mone cosy doses fom Germany because they were not icensed in he United Stats ‘Many sate officials abo began looking fr alternative methods to clvain the yoesine for thei high-risk popolatons. linois Governor Rod SBogoevieh (D) located 750,00 doses oterseas and requested permission mathe BDA to purchase them. In New York City, Mayor Michael Bloombeeg (R) requested 00,000 doses of che fu vacine fom federal ih ages for high-risk residents. When dh request as denied, Flu Vaccine 51 Bloomberg decided to spend $2 milion to buy vaccines from mamafitar- tein Germany and Canasy however hat purchase would ao require EDA approval ‘rtunately, previous enperience indieats that people will not rsh to purchase these delayed spp. For empl, during the 2000-200) th con, dhe Ite shipments went unnsel or Soldat very low prices. Rod Wason, president of Prevention MD, an immunization and medical screening company in Seat, Washingon, cancelled numerous fy shot ‘Shucs in Octobe, and by Deceber 200 had excess shot he could barely {Biv aay le alone sel #9. The same lack of demand occurred in states Nchas California, Colorado, and Tess, despite the fct that December ‘uctinacons would sl protect many people during the peak fm February CONCLUSION “Appensices A and B provide simmary information about iflvenza forts font figures and fi tie line for 2004-2008 Te evident tha nfloenaa ‘kes numberof healthcare ple poi sses, including the Following + Highs populations need vaccines. ‘The market fr fa vaccines unsible and unpredictable ‘The FDA relies on companies to provide vaccines, but may 0 be uf= Siiently monivoring those companis, Te federal government is aware ofthe problems associated with the flu vaccine market but has no long-term plan for addressing these problems «+ When a vacine shortage does acu, there has been a lack of federal ‘coordination to act +The United States needs a satket, note competing flu vaccine production ‘The falling ole phy options ean facitae the discussion ofthese and other ses Oprion 1: "Toe Fa Vaesine Administration Tsk Fores pein 2; Vlow Will Georgia Proce leaf Nex Ye Opsion 3: Wining Policy Brief “The instructor will assign students to any o al ofthe options and ssn roles within ech