Provider Information: Influenza VISs

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1 Prvider Infrmatin: Influenza VISs Thirteen influenza vaccine prducts are apprved fr use in the United States fr the influenza seasn: Name Manufacturer Age Range # f Strains Afluria bicsl 9 years and lder* Trivalent Fluarix GSK 3 years and lder Trivalent Quadrivalent Flublk Prtein Sciences years Trivalent Flucelvax Nvartis 18 years and lder Trivalent FluLaval GSK 3 years and lder Trivalent Quadrivalent FluMist Medimmune 2 49 years Quadrivalent Fluvirin Nvartis 4 years and lder Trivalent Fluzne Sanfi Pasteur 6 mnths and lder Trivalent Quadrivalent Fluzne High-Dse Sanfi Pasteur 65 years and lder Trivalent Fluzne Intradermal Sanfi Pasteur years Trivalent *Afluria is licensed fr ages 5 and lder, but ACIP recmmends that it nt be used in children 5 thrugh 8 years f age because f increased reprts f febrile reactins in this age grup. If n ther age-apprpriate, inactivated influenza vaccine is available fr a child 5 thrugh 8 years f age wh has a medical cnditin that increases the risk fr influenza cmplicatins, Afluria can be used. Hwever, prviders shuld first discuss the benefits and risks f vaccinatin with Afluria with the child s parent r caregiver. Afluria may be used in persns 9 years f age and lder. Influenza Virus Strains in the Vaccines Trivalent frmulatins will cntain these strains: A/Califrnia/7/2009 (H1N1)-like A/Texas/50/2012 (H3N2)-like B/Massachusetts/2/2012-like (Yamagata lineage) Quadrivalent frmulatins will als include: B/Brisbane/60/2008-like (Victria lineage) These are the same strains as thse in the vaccines. Abbreviatins used fr influenza vaccines IIV: Inactivated Influenza Vaccine (Afluria, Fluarix, FluLaval, Fluvirin, Fluzne) (IIV3 = Trivalent IIV; IIV4 = Quadrivalent IIV) LAIV4 (Quadrivalent): Live, Attenuated Influenza Vaccine (FluMist) RIV3: Recmbinant Influenza Vaccine, Trivalent (Flublk) cciiv3: Cell Culture Inactivated Influenza Vaccine, Trivalent (Flucelvax) [Nte: Fr simplicity s sake, IIV3, IIV4, RIV3 and cciiv3 will be referred t cllectively as IIV in this dcument.] Cncurrent Administratin Influenza vaccines may be administered cncurrently with ther live r inactivated vaccines.

2 New fr : LAIV Preferred fr Healthy Children 2 thrugh 8 Years f Age If yu have LAIV n hand, CDC recmmends that it be used fr healthy children 2 thrugh 8 years f age wh have n cntraindicatins r precautins. This recmmendatin is based n several studies that have demnstrated superir efficacy f LAIV in children. If LAIV is nt immediately available, IIV shuld be used. Vaccinatin shuld nt be delayed in rder t get LAIV. Bth LAIV and IIV are safe and effective. Peple at Highest Risk fr Influenza Cmplicatins & Their Clse Cntacts Influenza vaccinatin is recmmended fr everyne 6 mnths f age and lder. Hwever, it is mst imprtant fr peple at risk fr cmplicatins frm influenza infectin, and fr peple wh care fr them. In the event f limited vaccine supply, vaccinatin effrts shuld fcus n vaccinating these grups: Peple at Highest Risk fr Influenza Cmplicatins all children 6 thrugh 59 mnths f age, all persns 50 years f age and lder, anyne with chrnic pulmnary (including asthma) r cardivascular (except islated hypertensin), renal, hepatic, neurlgical, hematlgic, r metablic disrders (including diabetes mellitus), persns wh have immunsuppressin, including immunsuppressin caused by medicatins r HIV infectin, wmen wh are r will be pregnant during the influenza seasn, children and adlescents (6 mnths thrugh 18 years) wh are receiving lng-term aspirin therapy and wh might be at risk fr experiencing Reye s syndrme after influenza virus infectin, residents f nursing hmes and ther lng-term care facilities, American Indians and Alaska Natives, persns wh are mrbidly bese (BMI >40). Peple wh Live With r Care fr Thse at Highest Risk healthcare persnnel, husehld cntacts (including children) and caregivers f children yunger than 5 years (i.e., prir t the 5 th birthday) and adults 50 years f age and lder particular emphasis n vaccinating cntacts f children yunger than 6 mnths, husehld cntacts (including children) and caregivers f persns with medical cnditins that put them at higher risk fr severe cmplicatins frm influenza (see abve).

3 Vaccinating Children 6 Mnths thrugh 8 Years f Age Children 6 mnths thrugh 8 years f age shuld receive tw dses f influenza vaccine the first year they are vaccinated. Sme children in this age grup wh have been vaccinated previusly will als need tw dses. Use either this algrithm r the alternative apprach belw* t determine whether a patient 6 mnths thrugh 8 years f age shuld get 1 r 2 dses this seasn. Bth are acceptable. *As an alternative, yu may use the fllwing apprach fr children whse vaccinatin histry befre July 1, 2010 is knwn: Administer 1 dse f flu vaccine during the influenza seasn t a child 6 mnths thrugh 8 years f age wh received: - At least 1 dse f influenza vaccine, OR - 2 r mre dses f seasnal influenza vaccine since July 1, 2010, OR - 2 r mre dses f seasnal influenza vaccine befre July 1, 2010 and 1 r mre dses f mnvalent 2009(H1N1) vaccine, OR - 1 r mre dses f seasnal influenza vaccine befre July 1, 2010 and 1 r mre dses f seasnal influenza vaccine since July 1, 2010.

4 A child in this age grup wh des nt meet any f these cnditins shuld receive 2 dses in , at least 4 weeks apart. Cntraindicatins and Precautins Cnditins that are Cntraindicatins r Precautins fr Bth IIV and LAIV Guillain Barré Syndrme (GBS) As a precautin, persns wh are nt at high risk fr severe influenza cmplicatins and wh are knwn t have experienced GBS within 6 weeks f an influenza vaccine generally shuld nt be vaccinated. As an alternative, physicians might cnsider using influenza antiviral chemprphylaxis fr these persns. The benefits f influenza vaccinatin might utweigh the risks fr many persns wh have a histry f GBS and wh als are at high risk fr severe cmplicatins frm influenza. The number f new cases f GBS amng the general ppulatin is lw. But, peple with a histry f GBS have a much higher chance f experiencing GBS than peple with n histry f the disease. It isn't knwn whether the flu vaccine itself might increase the risk f GBS returning in peple wh have had GBS in the past. Acute Illness The presence f a mderate r severe acute illness with r withut a fever is a precautin t administratin f all vaccines. (ACIP General Recmmendatins n Immunizatin, p. 11) The definitin f mderate r severe acute illness is left t the clinical judgment f the prvider. A vaccinatin deferred because f an acute illness shuld be rescheduled after the illness has reslved. Severe Allergy t Vaccine Cmpnent / Allergic Reactin after Previus Dse A histry f a severe allergic reactin (e.g., anaphylaxis) after a previus dse f any influenza vaccine, r t any cmpnent f the vaccine being given is a cntraindicatin fr that vaccine. If a patient reprts a severe allergy t any substance, it may be crss-checked against the cntents listed n the manufacturer s package insert, r n the fllwing table. (NOTE: Sme patients have expressed a cncern that any antibitic allergy can be a reasn t avid influenza vaccinatin. Patients shuld be reassured that nly a rare life-threatening allergy t a substance is cause fr cncern, and that the vast majrity f allergies, including allergies t antibitics, are t mild t cause a vaccine t be withheld. Sme influenza vaccines cntain gentamycin, nemycin, and/r plymyxin, but many influenza vaccines d nt cntain any antibitic. See table belw. )

5 Substances shwn n this table include thse remved fllwing prductin, fr which nly a trace remains. If in dubt, check the package insert accmpanying the vaccine yu are using. Patients are unlikely t be aware f allergies t many f these substances. They are mre likely t knw if they are allergic t: Eggs. All influenza vaccines, with the exceptin f FluBlk, cntain egg prtein. See the fllwing sectin fr special instructins fr vaccinating egg-allergic patients. Antibitics, gelatin r latex. Because these are mre cmmnly recgnized allergies, they are highlighted n this table fr yur cnvenience. Vaccine Cntents Latex? Afluria Fluarix Flublk Flucelvax Fluvirin Flulaval Fluzne FluMist beta-prpilactne, thimersl (multi-dse vials nly), mnbasic sdium phsphate, dibasic sdium phsphate, mnbasic ptassium phsphate, ptassium chlride, calcium chlride, sdium taurdexychlate, nemycin sulfate, plymyxin B, valbumin, sdium chlride ctxynl-10 (Tritn X-100), α-tcpheryl hydrgen succinate, plysrbate 80 (Tween 80), hydrcrtisne, gentamicin sulfate, valbumin, frmaldehyde, sdium dexychlate, sucrse, phsphate buffer mnbasic sdium phsphate, dibasic sdium phsphate, plysrbate 20, baculvirus and hst cell prteins, baculvirus and cellular DNA, Tritn X-100, lipids, vitamins, amin acids, mineral salts Madin Darby Canine Kidney (MDCK) cell prtein, prtein ther than hemagglutinin, MDCK cell DNA, plysrbate 80, cetyltrimethlyammnium brmide, phsphate buffer, β-prpilactne nnylphenl ethxylate, thimersal (multidse vial trace nly in prefilled syringe), plymyxin, nemycin, beta-prpilactne, valbumin, phsphate buffer thimersal (multi-dse vial nly), frmaldehyde, sdium dexychlate, valbumin, phsphate buffer, α-tcpheryl hydrgen succinate, plysrbate 80 frmaldehyde, ctylphenl ethxylate (Tritn X- 100), gelatin (standard trivalent frmulatin nly), thimersal (multi-dse vial nly), valbumin, phsphate buffers, sucrse ethylene diamine tetraacetic acid (EDTA), mnsdium glutamate, hydrlyzed prcine gelatin, arginine, sucrse, dibasic ptassium phsphate, mnbasic ptassium phsphate, gentamicin sulfate, valbumin N August 2014 N June 2014 N March 2014 Yes (Syringe tip cap) Yes (Syringe tip cap) N (Vial) Frm Manufacturer s P.I. Dated March 2014 February 2014 N 2014 N 2014 N July 2014

6 Egg Allergy IIV and RIV: Use the fllwing algrithm when vaccinating a patient with a reprted r suspected egg allergy: *Persns with egg allergy may tlerate egg in baked prducts (e.g. bread r cake). Tlerance t eggcntaining fds des nt exclude the pssibility f egg allergy. Fr persns wh have n knwn histry f expsure t egg, but wh are suspected f being egg-allergic n the basis f previusly perfrmed allergy testing, cnsultatin with a physician with expertise in the management f allergic cnditins shuld be btained prir t vaccinatin. Alternatively, RIV3 may be administered if the recipient is 18 thrugh 49 years f age. LAIV: Because f relative lack f data demnstrating safety f LAIV fr persns with egg allergy, anyne with a histry f egg allergy shuld receive IIV r RIV rather than LAIV.

7 Cntraindicatins and Precautins fr LAIV Only Cntraindicatins: D nt administer LAIV t the fllwing grups: Anyne with cntraindicatins listed in the package insert: Children aged 2 thrugh 17 years wh are receiving aspirin r aspirincntaining prducts. Persns wh have experienced severe allergic reactins t the vaccine r any f its cmpnents, r t a previus dse f any influenza vaccine. Pregnant wmen. Immunsuppressed persns. Persns with a histry f egg allergy. Children aged 2 thrugh 4 years wh have asthma r wh have had a wheezing episde nted in the medical recrd within the past 12 mnths, r fr whm parents reprt that a health care prvider stated that they had wheezing r asthma within the last 12 mnths. Persns wh have taken influenza antiviral medicatins within the previus 48 hurs. (See abve fr details.) Precautins Persns f any age with asthma might be at increased risk fr wheezing after administratin f LAIV. The safety f LAIV in persns with ther underlying medical cnditins that might predispse them t cmplicatins after wild-type influenza infectin (e.g., chrnic pulmnary, cardivascular [except islated hypertensin], renal, hepatic, neurlgic, hematlgic, r metablic disrders [including diabetes mellitus]) has nt been established. These cnditins, in additin t asthma in persns 5 years f age and lder, shuld be cnsidered precautins fr the use f LAIV. A persn wh has received an injected live vaccine (MMR, varicella, zster, yellw fever) within the past 4 weeks shuld wait until 4 weeks have elapsed befre receiving LAIV, t avid ptential interference between live vaccines. Because antiviral drugs reduce replicatin f influenza viruses, LAIV shuld nt be administered until 48 hurs after cessatin f influenza antiviral therapy. If influenza antiviral medicatins are administered within 2 weeks after receipt f LAIV, the vaccine dse shuld be repeated 48 r mre hurs after the last dse f antiviral medicatin... with any apprved vaccine frmulatin. Persns wh care fr severely immunsuppressed persns wh require a prtective envirnment shuld nt receive LAIV, r shuld avid cntact with such persns fr 7 days after receipt, given the theretical risk fr transmissin f the live attenuated vaccine virus.

8 Safety Febrile Seizures An increased risk f febrile seizures (<1 per 1,000 children vaccinated) has been bserved in children 6 mnths thrugh 4 years f age wh received IIV3. The risk was higher amng children wh received PCV13 during the same visit. Taking int cnsideratin benefits and risks f vaccinatin, n plicy change was recmmended fr use f IIV r PCV13. N increased risk was bserved in children lder than 4 years f age after IIV3 r in children f any age after LAIV. During the flu seasn, an increased risk f febrile seizures (up t 9 per 1,000 dses) was bserved amng yung children in Australia, assciated with a Suthern Hemisphere vaccine similar t Afluria. Because f these findings, ACIP des nt recmmend Afluria fr children yunger than 9 years f age. Deltid Bursitis Severe shulder pain and reduced range f mtin in the arm where a sht was given is included n the IIV VIS. This ptential adverse event is being added t all updated VISs fr injected vaccines, in respnse t the Institute f Medicine reprt, Adverse Effects f Vaccines: Evidence and Causality (2012), which includes deltid bursitis amng injectin-related adverse events. A study reprting 13 cases, and three VAERS reprts were cnsidered. The reprt cncluded that, the evidence cnvincingly supprts a causal relatinship between the injectin f a vaccine and deltid bursitis. Nte that this adverse event is assciated with injectin, and nt specifically with influenza vaccine. The cmplete reprt can be fund at pages Guillain Barré Syndrme (GBS) and IIV The 1976 swine flu vaccine was assciated with increased frequency f GBS (abut 1 additinal case per 100,000 persns vaccinated). Influenza vaccines since then have nt been clearly assciated with GBS. Wrst-case estimates frm the few studies that suggest an assciatin between IIV and GBS are lw (apprximately 1 additinal case per millin persns vaccinated). GBS has als been nted t ccur in relatin t influenza illness. GBS has nt been assciated with receipt f LAIV.

9 Thimersal Thimersal, a mercury-cntaining antibacterial cmpund, is used in multidse vials f IIV t reduce the likelihd f bacterial grwth. LAIV, RIV, and mst single-dse vials r syringes f IIV are thimersal-free. Accumulating evidence shws n increased risks frm expsure t thimersal-cntaining vaccines. Persns recmmended t receive IIV may receive any age- and risk factr-apprpriate vaccine preparatin, depending n availability. Risk f Getting Influenza frm the Vaccine IIV/RIV Vaccines that d nt cntain live influenza virus cannt cause influenza disease. LAIV The influenza virus in LAIV is cld adapted and heat sensitive. That is, it has been engineered t replicate in the relatively lwer temperatures f the naspharynx, but nt in the relatively higher temperatures f the lungs. It des nt cause influenza disease in recipients. Peple vaccinated with LAIV can shed vaccine viruses and, rarely, these viruses can be transmitted t unvaccinated persns. Hwever, serius illnesses have nt been reprted amng unvaccinated persns wh have been infected inadvertently with vaccine viruses. Pregnancy Registries While IIV is indicated fr pregnant wmen, several manufacturers maintain registries t cllect data n pregnancy utcmes and newbrn health status frm wmen wh receive influenza vaccine while pregnant. Wmen wh receive the fllwing vaccines while pregnant, r their healthcare prviders, shuld be encuraged t cntact the apprpriate pregnancy registry: Fluarix (including quadrivalent): Flublk: Flulaval (including quadrivalent): Fluzne Quadrivalent r Fluzne Intradermal: Fr mre infrmatin: Mre cmplete and detailed infrmatin can be fund in the fllwing publicatins, frm which infrmatin in this dcument is predminantly derived: CDC. Preventin and Cntrl f Seasnal Influenza with Vaccines: Recmmendatins f the Advisry Cmmittee n Immunizatin Practices (ACIP) United States, Influenza Seasn. MMWR 2014;63 (N. 32), CDC. Preventin and Cntrl f Seasnal Influenza with Vaccines. Recmmendatins f the Advisry Cmmittee n Immunizatin Practices United States, MMWR 2013;62 (N. RR-07).

10 CDC. General Recmmendatins n Immunizatin Recmmendatins f the Advisry Cmmittee n Immunizatin Practices (ACIP). MMWR 2011;60 (N. RR-2). September 2014 Centers fr Disease Cntrl and Preventin

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