Immunization Update 2013

Immunization Update 2013Maine Pharmacy Association Fall ConventionSeptember 7, 2013

Allison Strobel, PharmDAssistant Professor Pharmacy PracticeHusson University School of PharmacyMPA Board of Directors Member

1DisclosureI, Allison Strobel, do not have an interest in selling a technology, program, product, and/or serviceI have no conflicts of interest Learning ObjectivesDiscriminate between the different branded influenza vaccines based on patients characteristicsDetermine in which patient the different pneumococcal vaccines would be warrantedIdentify the different travel vaccine resourcesApply principles of travel vaccines to specific patient travel plansOutlineInfluenzaPneumococcal DiseaseTdap Travel VaccinesThe Law Revisited LD 148 An Act to Amend the Laws Governing Drugs and Vaccines Administered by PharmacistsA pharmacist may not delegate the pharmacists authority to administer drugs or vaccines; except that a pharmacist licensed under this chapter who has obtained a certificate of administration pursuant to section 13832 may delegate the authority to administer adult vaccines to a pharmacy intern who is under that pharmacists direct supervision 6Influenza

7Influenza Virus Strains1Influenza A virusModerate to severe illnessAll age groupsHumans and other animalsInfluenza B virusMilder diseasePrimarily affects childrenHumans onlyInfluenza C virusRarely reported in humansNo epidemics82013 2014 Influenza Vaccine2,3A/California/7/2009(H1N1)-like virusA/Texas/50/2012(H3N2)-like virus*B/Massachusetts/2/2012-like virus*Yamagata lineage

B/Brisbane/60/2008-like virus^Victoria lineage

*Different than 2012-2013 vaccine^Quadrivalent vaccineEvolving Influenza virus Antigenic Drift4Occurs in both type A and type B Gradual changes to evade immune systemMutations, substitutions, deletions Epidemics occur in response to the changes10Evolving Influenza virus Antigenic Shift4Occurs in type ASudden, major change in hemagglutinin and/or neuromidiaseOccasional changeNew subtypeLittle human immunityPandemics occur in response to this change11Available Influenza VaccinesVaccine (Manufactuerer)Approved Age IndicationsFluzone (Sanofi Pasteur, Inc) 6 monthsFluvirin (Novartis)4 yearsFluarix (GSK) 3 yearsFluLaval (GSK) 18 yearsAfluria (CSL Biotherapies)9 yearsAgriflu (Novartis)18 yearsFluzone High-Dose (Sanofi Pasteur, Inc)65 yearsFluzone Intradermal (Sanofi Pasteur, Inc)18-64 yearsFlucelvax (Novartis) *18 yearsFlublok (Protein Sciences Corp) ^18-49 yearsFluMist (MedImmune) 2-49 yearsAdapted from APhA Pharmacy-Based Immunization Delivery April 2013*cell-cultured^ recombinantavailable in both trivalent and quadrivalent12New Influenza VaccinesInactivated, quadrivalent vaccine containing two type A and two type B strainsFluarix (GSK) approved for 3 years and olderFluzone (Sanofi Pasteur, Inc) approved for 6 months and olderFluLaval (GSK) approved for 18 years and olderInactivated, trivalent vaccine produced by cell culture (mammalian cells)Flucelvax (Novartis) approved for 18 years and olderInactivated, trivalent vaccine produced by recombinant technologyFlublok (Protein Sciences Corporation) approved for 18-49 yearsLive attenuated, quadrivalent vaccine containing two type A and two type BFluMist Quadrivalent (MedImmune) approved for 2-49 years 13Quadrivalent vs. Trivalent: Local Side Effects5Local Side EffectsFluarix Quadrivalent N=3,015Trivalent Influenza Vaccine (TIV)

TIV-1 TIV-2 (B Victoria) (B Yamagata) N=1,003 N=607Pain363731Redness222Swelling221Quadrivalent vs. Trivalent: Systemic Side Effects5Systemic Side EffectsFluarix Quadrivalent N=3,015Trivalent Influenza Vaccine (TIV)

TIV-1 TIV-2 (B Victoria) (B Yamagata) N=1,003 N=607Muscle Aches161916Headache161613Fatigue161815Arthralgia8109GI Symptoms776Shivering454Fever 99.5oF21215Flucelvax vs. Comparator: Local Side Effects6Local Side EffectFlucelvax (%)N=821Agriflu (%)N=841Injection site pain2015Erythema1415Induration66Swelling4416Flucelvax vs. Comparator: Systemic Side Effects6 Systemic Side EffectFlucelvax (%)N=821Agriflu (%)N=841Headache1211Fatigue1111Myalgia78Malaise1111Chills4417FluMist Quadrivalent vs. Trivalent Immune Response7Multicenter, randomized, double-blind study assessing immunogenicity of FluMist Quadrivalent compared to FluMist TrivalentChildren and adolescents 2-17 years: 2,312 subjectsAdults 18-49 years; 1,800 subjects The addition of the second B strain did not result in immune interference to other strains included in the vaccine

FluMist Quadrivalent vs. Trivalent : Side Effects in 2-17 years7Side EffectFluMist Quadrivalent (%)N=1341FluMist Trivalent (%)N=901Runny nose/Nasal congestion3232Headache1312Decreased activity (lethargy)1010Sore throat910Decreased appetite45Fever >100oF7519FluMist Quadrivalent vs. Trivalent : Side Effects in 18-49 years7Side EffectFluMist Quadrivalent (%)N=1197FluMist Trivalent (%)N=597Runny nose/Nasal congestion4440Headache2827Decreased activity (lethargy)1818Sore throat1920Cough1413Muscle aches1010Decreased appetite6520Fluzone Intradermal8IndicationPersons 18 64 years of ageDose0.1 mL (9mcg hemagglutinin)Similar seroprotection rate compared to IM influenza vaccine21Fluzone Intradermal vs. Intramuscular Adverse Events8Advisory Committee on Immunization Practices Recommendations9Annual vaccination of all person 6 months and older against influenzaFluMist Qaudrivalent indicated for healthy persons aged 2-49No preference given to once brand name influenza vaccine over another Begin to offer vaccine as soon as supply is available Children age 6 months to 8 years should receive 2 doses if first time receiving the vaccinationAll health care personal should be vaccinated23Intramuscular AdministrationDeltoid muscle1 inch, 25 gauge needle

Intranasal Administration0.1 ml dose in each nostril

Live Attenuated Influenza Vaccine Contraindications7Pregnant womenChronic medical conditions:Lung disease (i.e. asthma, COPD)Heart diseaseKidney or liver diseaseMetabolic disease (i.e. diabetes)Weakened immune systemSevere egg allergyQuestion 1Mrs. Jones is a 68 year old female who comes into your pharmacy today requesting a flu shot. She has no contraindications to receiving the vaccine today. Of the following influenza vaccines the pharmacy carries, which vaccine would be appropriate to administer to Mrs. Jones? i. Fluzone prefilled syringeii. Fluarix (quadrivalent) prefilled syringeiii. Fluzone High-Doseiv. Flu-Misti, iiii, iiii, ii, iiii, ii, iii, iv

Question 2Jimmy is a 9 year old boy who comes in today with his mother. Mrs. J would like to have Jimmy receive his influenza vaccine today at your pharmacy. After screening you find he has mild asthma and seasonal allergies. Which of the vaccines would be appropriate for Jimmy?

Fluzone IntradermalFluarix (quadrivalent)Flu-MistFluzone High-DosePneumococcal Disease

29Pneumovax23 PPSV2310Recommended for all patients over the age of 65Before 65 years if patient has chronic conditions Chronic illness (diabetes, heart disease, lung disease)AspleniaImmunocompromised Cochlear implantSmokersProtects against 23 serotypes; 11 are uniqueImproves patient outcomes if pneumococcal pneumonia develops

30PREVNAR13 PCV1311,12 Indicated for children 6 weeks to 5 years and adults over 50 yearsNot recommended by ACIP for routine use in adultsMain place in therapy is for immunocompromised adultsAspleniaCSF leaksCochlear implantsProtects against 13 serotypes; 1 is unique31Dosing Schedule12 PPSV nave patients PCV13 PPSV23 PPSV23 (PPSV23 after age 65) 8 weeks 5 years

Prior PPSV23 vaccination5 years PPSV23 PCV13 PPSV23 (PPSV23 after age 65) 1 year 8 weeks PPSV23 PPSV3 PCV13 (PPSV23 after age 65) 5 years 1 year PPSV23 PPSV23 (PPSV23 after age 65) PCV13 5 years 1 yearAdapted from APhA Pharmacy-Based Immunization Delivery April 201332Vaccinate all people over 65 years oldVaccinate earlier if:19-64 years: smoke, asthma2 years: chronic illnessIf second dose is neededMinimum of 5 years between dosesFirst dose given before 65th birthdayNot recommending Prevnar13 for routine use Immunocompromised patients can receive one doseAdvisory Committee on Immunization Practices Recommendations12,1333Question 3Stacy is a 55 year old female who has COPD (quit smoking 2 years ago upon diagnosis), hypertension, and hyperlipidemia. Her current medications include Spiriva, HCTZ, lisinopril, and Crestor. Which of the following immunizations would Stacy be indicated for?

PREVNAR13PneumovaxFluzoneA and C onlyB and C onlyAll three are indicatedTetanus, diphtheria, acellular pertussisTdap Vaccine14Boostrix (GSK) approved for 10 yearsAdacel (Sanofi Pasteur) approved for ages 11-64 Replaces one tetanus booster

TimingAdminister regardless of last Td vaccine36Whats New?15October 2012 updated ACIP recommendation Vaccinate women during each pregnancy Third trimester preferred (after 30 weeks)Possible adverse eventsIncreased injection site painArthus reactions, whole arm swelling

Dont forget about the fathers!37Timing and Spacing of Vaccines1Administer all indicated vaccines in the same visitIndividual vaccines in separate syringes injected at separate sitesLive vaccines are separated by 28 days if not administered at the same visitInactivated vaccines do not have a minimum interval between administration if not administered at the same visitVaccine Series:Increasing the interval between doses does not weaken immune responseDecreasing the interval between doses may weaken immune response and vaccines protection38Vaccines Types1Live AttenuatedIntranasal influenza, herpes zoster, measles, mumps, rubella, varicella, rotavirus, oral typhoid capsules, yellow feverInactivatedIntramuscular influenza, pneumococcal, tetanus, diphtheria, pertussis, human papillomavirus, hepatitis A and B, meningococcal, Haemophilus influenzae type B, inactivated poliovirus, rabies, intramuscular typhoid 39Travel Vaccines16

ImportanceTravelers can become infected while in a different country and may not develop symptoms until they return homeIntroduction of pathogens into new climates can have devastating effectsSmall pox introduction to North AmericaSyphilis introduction to EuropeRecent transmission of region specific diseasesSevere Acute Respiratory Syndrome (SARS) 200341Types of TravelersVacation BusinessMission Visiting Friends and FamilyTravel medicine is an art of managing a persons risk, not eliminating it

43Available ResourcesCDCs Travelers Health (http://wwwnc.cdc.gov/travel/)CDC Health Information for International Travel, The Yellow Book (http://wwwnc.cdc.gov/travel/page/yellowbook-home-2014) International Society of Travel Medicine (http://www.istm.org/)The American Society of Tropical Medicine and Hygiene (www.astmh.org//) Travel SoftwareShoreland Travax (http://www.shoreland.com/)Travel+Care International (http://www.travelcare.com/en/index.cfm)Tropimed (http://www.tropimed.com/en/index.html#&panel1-1)

44Vaccine Preventable Disease TyphoidJapanese EncephalitisRabiesTuberculosis*Cholera*Hepatitis A and BMeningococcal DiseasePoliomyelitis (adult booster) Yellow Fever

*Available in other countriesRequired to enter country45TyphoidLife-threatening febrile illness cause by Salmonella enterica serotype TyphiTransmitted by fecal-oral routeConsuming contaminated water or foodIncubation period of 6-30 days before gradual onset of symptomsFever and fatigue, headache, malaise, anorexiaRecommended for Highest risk: Southern Asia; visiting family and friendsHigh risk: East/Southeast Asia, the Caribbean, Africa, Central/South AmericaFood and water precautions should still be followed46Typhoid Vaccine VivotifOral live attenuated vaccine4 dose seriesOne capsule every other day 1 hour before a mealRestart regimen if more than 48 hours between dosesKeep refrigerated

Complete one week before exposureBooster after 5 yearsMinimum age: 6 yearsCommon adverse effectsAbdominal discomfort

47Typhoid Vaccine Typhim ViCapsular polysaccharide vaccineOne dose at least 2 weeks before exposureBooster after 2 yearsMinimum age: 2 yearsCommon adverse effectsHeadache, injection site reactions

48Japanese EncephalitisTransmitted by infected mosquitoesAcute encephalopathy is a classic symptomRecommended if traveling to agricultural portions of AsiaHigh risk: visiting family and friends Mosquito bite precautions ConsiderationsLow overall risk of transmissionDestination and length of stayCost

49Japanese Encephalitis Vaccine Ixiaro, JE-Vax (no longer available)Approved for 17 years or older2 dose series0, 28 daysComplete 1 week before travel Booster after 12 monthsCommon adverse effectsInjection site pain and tendernessFatigue, headache, influenza-like illnessContraindicated with hypersensitivity to protamine sulfate50RabiesTransmitted through animal biteIncubation period is 1-3 months post exposureSymptom development results in death within 7-14 daysPrevention with vaccine prior to or post bite exposure is key for survival

Consider vaccination when:Prevalence in visiting country is highUnknown availability of post-exposure antirabies biologicsUnknown duration of stay 51Rabies Vaccine Imovax, RabAvert3 dose series0, 7, 21-28 daysMust complete ALL 3 doses prior to travelNo booster for pre-exposure vaccinationCommon adverse effectsInjection site reactions, headache52Hepatitis AFecal-oral transmissionVirus levels peak 1-2 weeks before abrupt symptom onsetFever, malaise, anorexia, nausea, abdominal discomfortDisease usually resolves within 2 months Recommended if traveling outside the US regardless of destinationHighest risk: developing counties; visiting family and friends53Hepatitis A Vaccine Havrix, VaqtaTwinrix (combination with Hepatitis B)Standard 2 dose series0, 6-12 months (Havrix)0, 6-18 months (Vaqta)No Booster Common adverse effectsInjection site pain, headacheHepatitis BTransmitted through infected bodily fluidVirus incubation is usually 90 days before symptom on setMalaise, fatigue, anorexia, nausea, vomiting, abdominal pain, jaundiceAcute or chronic infectionRecommended for travel to high chronic endemic areas High risk: Africa and Asia; missionaries55Hepatitis B Vaccine Recombivax-HB, Engerix-BTwinrix (Combination with Hepatitis A)Standard 3 dose series0, 1, 6 monthAccelerated series0, 1, 2 months; 12 months (Engerix-B)0, 7, 21-30 days; 12 months (Twinrix)Common adverse effectsInjection site pain, fever

56Meningococcal DiseaseRequired immunization with the quadrivalent vaccine before attending Hajj in Saudi Arabia2000 outbreak of Neisseria meningitidis serogroup W-135Meningitis belt in sub-Saharan AfricaIncubation is generally 1-14 days before onset of sudden symptomsHeadache, fever, stiffness of neck, possible altered mental status

57Meningococcal Vaccine Menactra, Menveo, MenomuneOne dose seriesMenactra and Menveo administered IMMenomune admistered SQBooster every 5 years if at continued riskProtective antibody levels occurs 7-10 days after vaccinationCommon adverse effectsInjection site pain and rednessMenactra contraindicated in natural rubber latex allergyPolio17Fecal-oral transmission

Global Polio Eradication Initiative As of August 20, 2013 192 polio cases have been reported from the three remaining endemic countries: Afghanistan, Nigeria, and PakistanIn 2012 there were five countries with endemic polio (wild-type): Afghanistan, Chad, Niger, Nigeria, and Pakistan

59Polio Vaccine Inactivated Polio Vaccine (IPV)Standard 3 dose series 0, 4-8 weeks, 6-12 months (after second dose)Single adult booster dose if neededCommon adverse effectsInjection site pain and redness

Oral Polio Vaccine (OPV) no longer availableVaccine-associated paralytic poliomyelitis (VAPP)60Yellow FeverTransmitted by infected mosquitoHigh viremia shortly before fever and for 3-5 days after onset of symptomsInfluenza-like illness before decompensation Required for entrance into specific countries in sub-Saharan Africa and tropical South America

Immunizer needs special certificate obtained from state medical director 23 vaccination sites available in Maine61Yellow Fever Vaccine YF-VaxLive-attenuated vaccineOne dose very 10 yearsRare serious adverse eventsHypersensitivity and yellow fever vaccine-associated neurologic diseaseConsidered valid after 10 days post vaccination per International Health RegulationsDocumented on International Certificate of Vaccination or Prophylaxis62Other Travel Health ConcernsMalariaTravelers DiarrheaAltitude Illness/Acute Mountain SicknessJet LagMotion SicknessUTIYeast Infections63Question 4You have decided to start a travel health clinic in your pharmacy. Which of the following is/are a good resource to help you determine which vaccines are needed for a person traveling outside of the United States?

The Pink BookCDC websiteThe Yellow Book CDC Vaccine ScheduleQuestion 5Bobby and Sue are planning their honeymoon to India (staying at higher end hotels in populated cities traveling to popular tourist destinations) and have come to you today to see what vaccines they will need. Both Bobby and Sue are up-to-date with standard recommended vaccines. After entering the travel destination into the CDC Travelers Health; the following are possible vaccines: Hepatitis A and B, Japanese Encephalitis, Malaria prophylaxis, Polio, Rabies, Typhoid, and Yellow Fever. Which vaccines do you recommend?i. Hepatitis Av. Polioii. Hepatitis Bvi. Rabiesiii. Japanese Encephalitisvii. Typhoidiv. Malaria prophylaxisviii. Yellow Feveri, ii, iv, vi, iv, viii, ii, iv, vii, viiiAll of the vaccines are recommendedSummaryFluMist is available only in quadrivalent formulationFluzone, Fluarix, FluLaval available in either quadrivalent or trivalent formulationsACIP does not recommend one influenza vaccine over the either for persons eligible for specific vaccinePneumovax should be administered to anyone who is eligibleACIP recommends Prevnar only for immunocompromised patientsTravel medicine is a unique area pharmacists can have an impact in and there are multiple resources to aid in the decision of which vaccine to give whenReferencesEpidemiology and Prevention of Vaccine-Preventable Diseases; 12th Edition. Available at http://www.cdc.gov/vaccines/pubs/pinkbook/index.htmlRecommended composition of influenza virus vaccines for use in the 2013-2014 northern hemisphere influenza season. World Health Organization. Available at http://www.who.int/influenza/vaccines/virus/recommendations/2013_14_north/en/index.htmlInfluenza Virus Vaccine for the 2013-2014 Season. U.S. Food and Drug Administration. Available at http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/post-marketactivities/lotreleases/ucm343828.htm How the Flu Virus Can Change: Drift and Shift Centers for Disease Control and Prevention. Available at http://www.cdc.gov/flu/about/viruses/change.htm Fluarix[package insert]. GlaxoSmithKline Inc;2013Flucelvax[package insert]. Novartis Vaccines and Diagnostics Inc;2013FluMist Quadrivalent [package insert]. MedImmune Inc; 2012.Arnou R, Eavis, P, et.al. Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years; Randomized, controlled phase III trial. Human Vaccins. 2010;6:346-54Summary Recommendations: Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices United States, 2013-14. Centers for Disease Control and Prevention. Available at http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm Pneumovax23 [package insert]. Merck Sharp & Dohme Corp.]2013Prevnar [package insert]. Wyeth Pharmaceutical Divison]2010Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2012;61(40):816-819Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 1997;46(R-8):1-28Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2011;60(01):13-15Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2013;62(07):131-135CDC Health Information for International Travel; 2014 Edition. Available at http://wwwnc.cdc.gov/travel/page/yellowbook-home-2014 Updates on CDCs Polio Eradication Efforts. Centers for Disease Control and Prevention. Available at http://www.cdc.gov/polio/updates/ Questions