Immunization Update 2016 · • Influenza activity was lower and peaked later compared to past 3...

ImmunizationUpdate:2016

GoldenPeters,PharmD,BCPSAssociateProfessor,PharmacyPracticeDepartment

St.LouisCollegeofPharmacy

FacultyDisclosure

• GoldenPetersdeclaresnoconflictsofinterest,realorapparent,andnofinancialinterestsinanycompany,product,orservicementionedinthisprogram,includinggrants,employment,gifts,andstockholdings

PharmacistLearningObjectives

• Discussthenew2016AdvisoryCommitteeonImmunizationPractices(ACIP)recommendationsregardingadultandpediatricimmunizations• Reviewinfluenzavaccineconsiderationsinpreparationforthe2016-2017season• Applyimmunizationrecommendationstospecificpatientscenarios

TechnicianLearningObjectives

• Discussthenew2016AdvisoryCommitteeonImmunizationPractices(ACIP)recommendationsregardingadultandpediatricimmunizations• Reviewinfluenzavaccineconsiderationsinpreparationforthe2016-2017season• Evaluatespecificpatientscenariostoscreenforvaccinecandidates

Pre-testQuestion#1

Whatinfluenzavaccinecanbeusedinpatientswithaneggallergyofanyseverity?

A. IIVB. RIVC. LAIVD. ccIIV

Pre-testQuestion#2

Whenadministeringaninfluenzavaccination,howlongshouldthepatientbeobserved?

A. 15minutesB. 30minutesC. 45minutesD. 60minutes

Pre-testQuestion#3

Whichvaccinerecentlydisplayedpoorvaccineefficacy,leadingtheACIPtorecommenditnotbeusedatthistime?• FluMist• Prevnar• Gardasil• Menactra

Pre-testQuestion#4

Whichofthefollowingisacholeravaccine?A. ACAM2000B. DengvaxiaC. TrumenbaD. Vaxchora

Pre-testQuestion#5

Canbothmeningococcalvaccines(MenBandserogroupsA,C,W,&Y)begivenonthesameday?

A. Yes,attheexactsametimeB. Yes,butatdifferentinjectionsitesC. No,theyshouldbeseparatedby1monthD. No,theyshouldbeseparatedby6months

Pre-testQuestion#6

Apatientreceived2dosesofTrumenba,forthethirdinjectionthereisonlyBexseroavailable.Whatisthebestcourseofaction?

A. GivethefinaldoseasBexseroB. Thedosingseriesiscompleteat2dosesC. ThesetwovaccinesarenotinterchangeableD. Provide2dosesofBexserotofinishtheseries

Pre-testQuestion#7

A66yearoldpatientreceivedPPSV23atage63whatistheappropriatedpneumococcalvaccinationrecommendationforthispatient?

A. OnlyPCV13nowB. PCV13now,6monthslaterPPSV23C. PPSV23now,6monthslaterPCV12D. PCV13now,12monthslaterPPSV23

Agenda

• SummarizeACIPrecommendationssinceSeptember2015toAugust2016• Discussadultimmunizationchanges• Discusschildhoodimmunizationchanges• Highlightinfluenzatreatmentchanges

DearPharmacistLetter…

• AnneSchuchat,MD,AssistantSurgeonGeneralandPrincipalDeputyDirector,CDC• CDCapplaudedtheaccomplishmentofthepharmacyprofession• 20yearsofservice

• Improvedhealthinourcommunities• Reducedriskofvaccine-preventabledisease• Expandedimmunizationauthority• Improvedvaccinationsrates• Commitmentto“walkingthewalk”• Collaboratingwithotherproviders

• RecognizedAPhA’sPharmac-BasedImmunizationDeliveryCertificationTrainingProgram• Upcoming20th anniversary• Trainedmorethan260,000pharmacists

Pharmacist.comCDCLetter.2015.

AdvisoryCommitteeonImmunizationPractices(ACIP)• Members• 15expertsinthefieldofimmunization• Ex-officioMembers(9)• LiaisonMembers(33)

• Mission• AdviceandguidancetotheCDC• Developrecommendations• Reducevaccine-preventabledeaths

• Meet3times/year• Subcommitteesmeetmoreoften• Opentothepublicandavailableonlivewebcast

Source:http://www.medscape.org/viewarticle/767661_transcript

ChildhoodImmunizationUpdates

Source:http://www.keyshealthystart.org/general/newborn-and-toddler

ImmunizationSchedule

• Reconfiguredscheduletolistvaccinationbyageofadministration• Earliesttolatestageoffirstrecommendedadministration• Goal:

• Improvereadability• Allowforgoldbarstoalignunderagewhenfirstrecommended

MMWR.February2,2016.65.

CDC.gov.VaccineSchedules2015.

CDC.gov.VaccineSchedules2016.

HumanPapillomavirusVaccine

• HPVvaccinationrecommendations:• Routineadministrationat11or12yearsofage• Catch-upvaccinationcanoccurupto26yearsold• Administerbeginningat9yearsoldforanyhistoryofsexualassault• Noneedforrevaccinationoncecompletingafullseries

MMWR.February2,2016.65.Source:http://www.medicalnewstoday.com/articles/246670.php

MeningococcalVaccine

• Meningococcalvaccinationrecommendations:• Routinevaccinationforpeople>10yearsathighriskforMenBdisease

• Asplenia• MicrobiologistroutinelyexposedtoNeisseriaMeningitidis

• Two-doseorthree-doseseriesofeitherMeningococcalB(MenB)vaccine• Bexsero(MenB-4c)(2doses)• Trumenba(MenB-FHbp)(3doses)

• Short-termprotectionagainstMenBstrainsforpersons16to23yearsold• ThereisnopreferenceforMenBvaccines

• TheyareNOTinterchangeable

MMWR.February2,2016.65.Source:http://www.multivu.com/Source:http://www.mainstreetvacs.com/partners/

MeningococcalVaccine

• Meningococcalvaccinationrecommendations:• Routinevaccinationat11or12yearsoldwithaquadrivalentmeningococcalvaccineremainsunchanged• Boosterdoseatage16• (Menactra[MenACWY-D])

• Bothmeningococcalvaccinescanbeadministeredatthesameofficevisit• Differentinjectionsites

MMWR.February2,2016.65.

Diphtheria,TetanusandPertussis(DTaP)Vaccine

• DTaPvaccinationrecommendations:• FourthdoseofDTaPusuallygivenat15monthsofage

• Canbegivenat12monthsoldIFseparatedfromthirddosebyatleastsixmonths

MMWR.February2,2016.65.

AdultImmunizationUpdates

Source:http://tetonfamilymagazine.com/ourfrontporch/childhood-vaccines-whos-calling-the-shots

HumanPapillomavirusVaccine

• HPVvaccinationrecommendations:• AddednonavalentHPVvaccine(Gardasil)asoneofthreeformulationsapprovedforroutinevaccination• Routinevaccinationforpersons11or12yearsold

• Women:administerthrough26yearsold• Men:administerthrough21yearsold

• Menathighrisk:administerthrough26yearsold

• Norevaccinationrecommendationforthosepreviouslycompletingafullseries

MMWR.February2,2016.65.

MeningococcalVaccine

• Meningococcalvaccinationrecommendations:• Personsatincreasedriskshouldberoutinelyvaccinatedwithquadrivalentmeningococcalvaccine(Menactra[MenACWY-D])• HIVisNOTanindicationforroutinevaccinationwithMenACWY-DorMenBvaccine(MMWR.Feb.2,2016)• June2016,ACIPrecommendsMenACWY-DvaccinetoHIVinfectedpatientsages2monthsandolder• 2doseseries,2monthsapart

MMWR.February2,2016.65.MMWR.October23,2015.64(41).

PneumococcalVaccine

• Pneumococcalvaccinationrecommendations:• 13-valentpneumococcalconjugatevaccine(PCV13[Prevnar13])• 23-valentpneumococcalpolysaccharidevaccine(PPSV23[Pneumovax])

• Immunocompetentadults65yearsandolder,separatePCV13andPPSV23vaccinesby1years• 2015recommendation:6– 12months

• Immunocompromisedadults> 19yearsold,separatePCV13andPPSV23byeightweeks

• Asplenia,CSFleak,cochlearimplant,HIV

• PCV13andPPSV23shouldNOTbeco-administered• PPSV23inadvertentlygivenearly,donotrepeat

MMWR.February2,2016.65.MMWR.September4,2015.64(34).

PneumococcalVaccineinPatients> 65YearsOld

MMWR.September4,2015.64(34).

Source:http://eziz.org/assets/docs/IMM-1152.pdf

SmallpoxVaccine

• Smallpoxvaccinationrecommendation:• Livesmallpox(vaccinia)vaccine(ACAM2000)

• FDAapprovalin2007,replacingDryvax• RoutinevaccinationwithACAM2000for:

• Laboratorypersonneldirectlyhandling:• Culturesorcontaminated/infectedanimalswithvacciniavirus

• HealthCarepersonnel(e.g.physiciansandnurses)• Currentlytreatoranticipatetreatingpatientswithvacciniavirusinfection

• PersonsadministeringACAM2000smallpoxvaccine

MMWR.March18,2016.65(10).Source:http://www.historyofvaccines.org/content/acam2000-vaccine

http://www.vaccinationinformationnetwork.com/revolts-and-opposition-against-compulsory-smallpox-vaccination/

CholeraVaccine

• Choleravaccinationrecommendation:• Choleravaccine(Vaxchora)

• FDAapprovalJune10,2016• Onlyvaccineavailabletopreventcholeraatthistime

• Indicatedforcholerapreventionfortravelersages18– 64toareasofactivecholeratransmission

• Singledose,liveattenuatedoralvaccine• Administered10daysormorebeforetravel• Durationofcoverageisunknown

• (3– 6months)

AAFP.News.ACIPRecommendationJune2016.Source:http://www.vaxchora.com/

Source:http://www.who.int/gho/epidemic_diseases/cholera/epidemics/en/

InfluenzaVaccineSource:http://www.davegranlund.com/cartoons/2009/10/06/flu-vaccine-categories/

InfluenzaSeason2015– 2016

• October4th,2015– May21st,2016intheUS• Influenzaactivitywaslowerandpeakedlatercomparedtopast3seasons• Peakedinmid-March2016• Overallinfluenzaactivitywasmoderate,comparedtolast3seasons:• Lowerpercentageofoutpatientvisits• Lowerhospitalizationsrates• Lowerpercentageofdeathsattributedtopneumoniaandinfluenza

MMWR.June10,2016.65(22).Source:https://blog.pkids.org/tag/flu/

March

MMWR.June10,2016.65(22).

March

MMWR.June10,2016.65(22).

MMWR.June10,2016.65(22).

2015-2016Peak

2010-2011Peak

2014-2015Peak

2009-2010Peak

2013-2014Peak

InfluenzaSeason2015– 2016

• Predominantstrains:• InfluenzaA:H1N1pdm09

• Vaccineeffectiveness(VE)• Overall:47%• Astrain:41%• Childrenage2– 17yearsold

• Inactivatedinfluenzavaccine(IIV):63%• Liveattenuatedinfluenzavaccine(LAIV):3%

CDC.ACIPJuneMeeting2016.

InfluenzaSeason2015– 2016

• VaccineAdverseEventReportingSystem(VEARS)• Nofoundsafetyconcernsforanyinfluenzavaccine

CDC.ACIPJuneMeeting2016.Source:https://www.focusforhealth.org/ethics-and-finance-flu-shot-studies/

InfluenzaVaccine

• LAIV(FluMist)offerednoprotectionagainstinfluenzainchildrenlastseason• PoororlowerthanexpectedVEforLAIVforthepast3seasons

• ACIPrecommendsagainst usingLAIVforthe2016– 2017influenzaseason• Approvedforuseinpeople2– 49yearold

• FDAhasnotactedagainstLAIV• Waitingformoreinformation

CDC.ACIPJuneMeeting2016.Source:https://www.flumistquadrivalent.com/

InfluenzaVaccine

• PossiblecausesforLAIV’slackofeffectiveness:• PoorperformanceoftheAvaccinestainasanasalformulation• InterferencebytheadditionalBstraininthequadrivalentformulation

• AstraZenecamanufactureofFluMist:• Projectedtomake14milliondosesofFluMist• Unsureifpre-orderedsupplieswillberefundable

• Needlephobiasorvaccine-hesitantpatientsshouldNOTuseLAIV• ProposedlanguagetotheCDCDirectorforfinalapproval• “LAIVshouldnotbeusedinanysetting”

CDC.ACIPJuneMeeting2016.

InfluenzaVaccine

• Clarificationforeggallergies:• Patientswithknownallergiestoeggs,regardlessofseveritycanreceiveanyinfluenzavaccine:• Inactivatedinfluenzavaccine(IIV)• Recombinantinfluenzavaccine(RIV)• Liveattenuatedinfluenzavaccine(LAIV)

• Post-vaccinationobservationshouldbe15minutesforallpatientsreceivingvaccines• Whythechange?

• Mostreactionstovaccinesareafterthe30minuteobservationperiod(oldrecommendation)• Reactionsareveryrare(1inamillion)

MMWR.February2,2016.65.Source:http://kidshealth.org/en/kids/egg-allergy.html

InfluenzaSeason2016– 2017

• InfluenzaseasonisOctobertoMay• CommonlypeaksinJanuarytoFebruary• Annualinfluenzavaccinationisrecommendedforallpersons6monthsofageandolder

Source:http://www.pikecountyhealth.com/v3/

InfluenzaSeason2016– 2017

• AnnuallytheWHOresearcheswhichinfluenzastrainswilllikelybethemostcommon• TheFDAthenconsidersthesesuggestions• Recommendedinfluenzavaccinescomposition(2016- 2017)

• Trivalentvaccine:• A/California/7/2009(H1N1)pdm09-likevirus• A/HongKong/4801/2014(H3N2)-likevirus• B/Brisbane/60/2008-likevirus

• Quadrivalentvaccine:• B/Phuket/3073/2013-likevirus

MMWR.June10,2016.65(22).

InfluenzaSeason2016– 2017

• Totalamountofinfluenzavaccinespredictedtobeproduced:• 175milliondoses

• Rememberthiswillbereducedby14millionFluMistVaccines• Shortage???

• Similartolastyear,171– 179millionpredicted

MMWR.June10,2016.65(22).

VaccinesinthePipeline

• Ebola• 100%efficacy(Guineatrial)• Singledose,storedat-80°C

• Dengue• Dengvaxia(Sanofi)• ApprovedinMexico

• 79%pooledefficacyagainstseveredengue• WHOrecommendsuseinendemicdengueareas

• Zika• ~21vaccinecandidates• NIHhasbeguntestinginhumans

Source:http://www.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/dengue

Post-testQuestion#1

Whatinfluenzavaccinecanbeusedinpatientswithaneggallergyofanyseverity?

A. IIVB. RIVC. LAIVD. ccIIVE. Alloftheabove

Post-testQuestion#2

Whenadministeringaninfluenzavaccination,howlongshouldthepatientbeobserved?

A. 15minutesB. 30minutesC. 45minutesD. 60minutes

Post-testQuestion#3

Whichvaccinerecentlydisplayedpoorvaccineefficacy,leadingtheACIPtorecommenditnotbeusedatthistime?• FluMist• Prevnar• Gardasil• Menactra

Post-testQuestion#4

Whichofthefollowingisacholeravaccine?A. ACAM2000B. DengvaxiaC. TrumenbaD. Vaxchora

Post-testQuestion#5

Canbothmeningococcalvaccines(MenBandserogroupsA,C,W,&Y)begivenonthesameday?

A. Yes,attheexactsametimeB. Yes,butatdifferentinjectionsitesC. No,theyshouldbeseparatedby1monthD. No,theyshouldbeseparatedby6months

Post-testQuestion#6

Apatientreceived2dosesofTrumenba,forthethirdinjectionthereisonlyBexseroavailable.Whatisthebestcourseofaction?

A. GivethefinaldoseasBexseroB. Thedosingseriesiscompleteat2dosesC. ThesetwovaccinesarenotinterchangeableD. Provide2dosesofBexserotofinishtheseries

Post-testQuestion#7

A66yearoldpatientreceivedPPSV23atage63.Whatistheappropriatedpneumococcalvaccinationrecommendationforthispatient?

A. OnlyPCV13nowB. PCV13now,6monthslaterPPSV23C. PPSV23now,6monthslaterPCV12D. PCV13now,12monthslaterPPSV23

Source:http://aboutdavidgeier.com/

ImmunizationUpdate:2016

GoldenPeters,PharmD,BCPSAssociateProfessor,PharmacyPracticeDepartment

St.LouisCollegeofPharmacy