adult immunization update: a focus on zoster and
TRANSCRIPT
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Adult Immunization Update:A Focus on
Zoster and Pneumococcal Vaccines
Mona Niki Marzban, Pharm.D. Adjunct Assistant Professor of Pharmacy Practice
PGY 1 Community Based Clinical Pharmacy Practice ResidentUniversity of Southern California/Ralphs Pharmacy
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Learning Objectives
By the end of the session, participants may:
• review the pathophysiology related to shingles and pneumonia• describe the immunization current guidelines to protect against shingles and pneumonia
• evaluate the clinical efficacy of available vaccines
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Herpes Zoster Virus Epidemiology
• 1.2millioncasesannuallyintheUS• 1in3peopleintheUSwilldevelopshinglesintheirlifetime
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Herpes Zoster Virus Risk Factors
Hx:wild-typeVZV
VaricellaVaccine
IncreasingAge
ImmunocompromisingCondition
Potential:GenderandEthnicity
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Varicella + Herpes Zoster Virus Pathophysiology
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Herpes Zoster Virus Details
• Unilateral vesicular dermatomal eruption• Impacts T3 to L3 dermatomes • + trigeminal nerve
• Localized vs Disseminated• Initial presentation within 48-72 hours of reactivation• Vesicular lesions continue to develop for 3-5 days • Total duration: 7-10 days • Recovery: 2-4 weeks
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Herpes Zoster Virus Complications
NEUROLOGIC OPHTHALMIC CUTANEOUS VISCERAL
• PHN• Motor Neuropathy• Cranial Neuritis• Meningoencephalitis• Transverse Myelitis
• Keratitis• Iritis• Retinitis• Visual Impairment
• Bacterial Superinfection• Scarring• Disfigurement
• Pneumonitis• Hepatitis
Shingles costs approximately $566 million in healthcare costsShingles results in the average loss of more than 129 hours per episode.
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2008: 6.7%
2020: 30%
Herpes Zoster Virus Vaccine Coverage
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Herpes Zoster Virus CDC Guidelines
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Herpes Zoster Virus Vaccination
CDC RECOMMENDATION MERCK RECOMMENDATION
> 60 Years Old > 50 Years of Age
ZOSTAVAX SCHEDULE
…Why the Difference?..
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Herpes Zoster Virus Vaccination
CDC RECOMMENDATION
> 60 Years Old
ZOSTAVAX SCHEDULE
• Zostavax efficacy wanes within 5 years • Protection beyond 5 years is uncertain • Lack of long-term data on < 60 years old
…Why the Difference?..
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A Comparison: Rates of Zostavax Coverage
UNITED STATES (n=208,505) CALIFORNIA (n=2,406)
2015 COVERAGE:• 35.4%
• 35.2% Non-Hispanic White• 30.2% Asian• 16.7% Hispanic• 16.0% Black
2015 COVERAGE:• 35.5%• 42% Non-Hispanic White• 25.4% Other Racial/Ethnic Group
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Zostavax Awareness and Coverage
UNITED STATES (n=208,505) 2014 Behavioral Risk Factor Surveillance System
COVERAGE:• 2007: 1.9%• 2014: 31.8%• 2015: 35.4%
• Age: > 60 Years• Gender: Female• Employment: Not in Workforce• Household Income: >$20,000• Region: Midwest, South• Perceived Health: Fair – Excellent• Insurance: Endorses Having• Provider: Endorses Having• Routine Checkup: Within Previous Year• Barrier to Seeing MD: Endorses No Barrier
AWARENESS:• 2007: 27%• 2014: 73.4%• 2015: 86.6%
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Clinical Impact of Zostavax
• 51% decreased shingles incidence • 61% decreased burden of illness • 66% decreased PHN incidence
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Zostavax Administration Barriers
• High cost • Freezer storage• Medicare Part D coverage • Lack of urgency to vaccinate • Lack of urgency to be vaccinated
STRATEGIES TO OVERCOME
• Pharmacist involvement • Reminder/recall systems • Educational campaigns • Standing orders• Linking immunization• Routine vaccine status assessment
ZOSTAVAX BARRIERS
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Immunosenesence Related to Zostavax
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Determining the Optimal Zostavax Schedule: a CE Analysis
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In the Pipeline: ShingrixLicensed by GlaxoSmithKline
HZ/su contains:• 50 μg lyophilized recombinant gE antigen • 0.5 ml liposome-based AS01B adjuvant system • 50 μg 3-O-desacyl-4’-monophosphoryl lipid A (MPL)• 50 μg Quilaja saponaria Molina, fraction 21
Pending Indication: Prevention of herpes zoster in adults > 50 years
• Non-live recombinant vaccine • 0.5 ml IM immunization administered at 0 and 2-6 months
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Shingrix: ZOE-50 Trial Efficacy Randomized | Observer-blind |Placebo-controlled| Multi-Center | Multinational | Phase III
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Shingrix: ZOE-50 Trial SafetyRandomized | Observer-blind |Placebo-controlled| Multi-Center | Multinational | Phase III
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Shingrix: ZOE-70 Trial EfficacyRandomized | Observer-blind |Placebo-controlled| Multi-Center | Multinational | Phase III
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Shingrix: ZOE-70 Trial EfficacyRandomized | Observer-blind |Placebo-controlled| Multi-Center | Multinational | Phase III
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Shingrix: ZOE-70 Trial Safety
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Shingrix: Pooled Analysis Efficacy
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Shingrix: Pooled Analysis Safety
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In the Pipeline: ShingrixLicensed by GlaxoSmithKline
HZ/su contains:• 50 μg lyophilized recombinant gE antigen • 0.5 ml liposome-based AS01B adjuvant system • 50 μg 3-O-desacyl-4’-monophosphoryl lipid A (MPL)• 50 μg Quilaja saponaria Molina, fraction 21
Pending Indication: Prevention of herpes zoster in adults > 50 years
• Non-live recombinant vaccine • 0.5 ml IM immunization administered at 0 and 2-6 months
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Epidemiology
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Pneumococcal Risk FactorsCOMMUNITY ACQUIRED PNEUMONIA HOSPITAL ACQUIRED PNEUMONIA
• Cigarette Smoking
• Elderly
• Indoor Air Pollution
• Underlying Pulmonary Condition
• Recent URTI
• Alcohol Use
• Immunocompromised Condition
• Immunocompromising Medications
• Prolonged Hospitalization
• Use of Gastric Acid Suppressants
• Nasogastric Intubation
• Prolonged Antibiotic Exposure
• Intensive Care Unit Setting
• Contaminated Personnel
• Inadequate Hygienic Procedures
COPD | Asthma | Chronic Liver Disease | Chronic Cardiovascular Disease | Diabetes
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Pneumococcal Pathophysiology
BUGS
• S. pneumoniae
• H. influenza
• M. pneumoniae
• Legionella
• C. pneumoniae
• Viral Superinfections
ROUTES
• Inhaled Particles
• Extrapulmonary Infection
• Oropharyngeal Aspiration
PREVENTATIVE MEASURES
• Hand washing
• Immunization
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Pneumococcal Complications COMMUNITY ACQUIRED PNEUMONIA
One of the MOST common causes of severe sepsis and infections cause of death in children and adults in the United States.
Bacteremia
Septic Shock
Lung Abscesses
Pleural Effusion
Empyema
Pleurisy
Renal Failure
Respiratory Failure
Multiple Drug Resistance
Otitis Media Pneumococcal Meningitis Death
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Pneumococcal Vaccine Coverage
• Noninstitutionalized Adults• > 65 Years Old: 90% by 2020• 18 to 64 Years Old: 60% by 2020
• Institutionalized Adults• 90% by 2020
GOALS
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CDC Pneumococcal Guideline
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Pneumovax 23
NO T-Cell Response, thus, NO B-cell memory formationEffectiveness of PPV in patients > 65 years old declines significantly within 5 years of vaccination
Used to prevent septicemia associated with S. pneumoniae pneumonia
14 Year Retrospective Study (1978 to 1992) showed: 57% overall efficacy against invasive infection in patients > 6 years old 75% efficacy against invasive infections in patients > 65 years old
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Prevnar 13
Community-Acquired Pneumonia Immunization Trial (CAPITA) 5 Years | 84,496 adults aged > 65 years• 31% overall efficacy of PCV protecting against S. pneumoniae • Strategy to achieve higher immunogenicity: administered one dose of PCV13 to those previously
vaccinated with PPSV23!
UPDATE: Indicated for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive pneumonia caused by the 13 strains in Prevnar 13.
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References • DiPiroPharmacotherapy:Chapter125:VaricellaandZosterVaccines
• Harrison’sPrinciplesofInternalMedicine:Chapter217:Varicella-ZosterVirusInfections
• CDC:ShinglesSurveillanceCDC:ShinglesClinicalOverviewNationalandState-SpecificShinglesVaccinationAmongAdultsAged> 60Years
• VaccinationofSpecialPopulations:ProtectingtheVulnerable
• PreventingShinglesandit’sComplicationsinOlderPersons
• DeterminingtheOptimalVaccinationScheduleforHZV:aCEAnalysis
• TheroleoftheTcellinage-relatedinflammation
• Efficacy,Safety,andTolerabilityofHerpesZosterVaccineinPersonsAged50–59Years
• InAdults> 70yearsofage,anadjuvantherpeszostersubunitvaccinereducedherpeszosteratamean3.7years
• EfficacyofHerpesZosterSubunitVaccineinAdults70YearsofAgeorOlder
• Immunogenicityandsafetyofanadjuvantherpeszostersubunitcandidatevaccineinadults≥50yearsofagewithapriorhistoryofherpeszoster:AphaseIII,non-randomized,open-labelclinicaltrial
• EfficacyofanAdjuvanted HerpesZosterSubunitVaccineinOlderAdults
• EfficacyandSafetyofInvestigationalHerpesZosterSubunitVaccineCandidateinAdults70YearsofAgeandOlder
• PrimaryEfficacyResultsforInvestigationalAdjuvanted HerpesZosterVaccineCandidateinAdults50YearsofAgeandOlderFromaPhaseIIIStudy
• AvailabilityoftheGlaxoSmithKlineAdjuvanted HerpesZosterSubunitVaccineCandidate
• Long-TermImmunogenicityandSafetyofanInvestigationalAdjuvanted HerpesZosterSubunitVaccineCandidateinAdults≥60YearsofAge
• Adultpneumococcalvaccination:advances,impact,andunmetneeds
• Timetofollowupwhencomparingstudiesofpneumococcalvaccines
• Preventingpneumococcalinfectionsinolderadults
• DevelopingBetterPneumococcalVaccinesforAdults
• IntervalsBetweenPCV13andPPSV23Vaccines:RecommendationsoftheAdvisoryCommitteeonImmunizationPractices(ACIP)
• Useof13-ValentPneumococcalConjugateVaccineand23-ValentPneumococcalPolysaccharideVaccineAmongAdultsAged≥65Years:RecommendationsoftheAdvisoryCommitteeonImmunizationPractices(ACIP)
• Useof13-ValentPneumococcalConjugateVaccineand23-ValentPneumococcalPolysaccharideVaccineforAdultswithImmunocompromisingConditions:RecommendationsoftheAdvisoryCommitteeonImmunizationPractices(ACIP)
• AdvisoryCommitteeonImmunizationPracticesRecommendedImmunizationScheduleforAdultsAged19YearsorOlder— UnitedStates,2017
*LinkstoPDFsavailanble uponrequest.