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Adult Vaccines: Update 2015 Thomas M File, Jr MD MSc MACP FIDSA FCCP Chair, Infectious Disease Division Summa Health System Akron, Ohio; Professor of Internal Medicine, Chair ID Section Northeast Ohio Medical University Rootstown, Ohio Objectives Review new developments in adult vaccines Focus on Influenza and pneumococcal vaccines Additional comments: Zoster, Tdap Burden of Vaccine-Adult Preventable Disease in the US Disease Annual Burden of Disease, United States Influenza 200,000 hospitalizations; 36,000 deaths (> 90% in older adults) Invasive pneumococcal disease 44,000 cases, 4500 deaths (higher rates of both in older adults and persons with comorbidities) Hepatitis B 51,000 infections (95% adults); 2000-3000 deaths; 1.25 million with chronic HBV infection Human papillomavirus 6.2 million new infections (>4000 women die in US annually; ? Male deaths) Pertussis 10,454 cases reported in 2007 (3152 adults) Severe illness in infants; often transmitted by older child or adult Zoster 1 million cases; risk for shingles and postherpetic neuralgia increases with age 4 Immunizations: Return on Investment Vaccine preventable infections represent significant Economic Burden Vaccine ROI: For each birth cohort vaccinated: 42,000 lives saved 20 million cases of disease prevented 13.6 billion dollars saved in direct costs 69 billion dollars saved total (with indirect cost) For each dollar spent, $10.20 saved Zhou et al. Arch Ped Adolesc Med. 2005 2013 Adult Immunization Coverage, US **Influenza Estimates 2013-14. MMWR. Feb 6, 2015. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6404a6.htm#Tab2 Healthy People 2020 Objectives on Immunization and Infectious Disease. www.Healthypeople.gov/2020/. Consequences of lapses of immunization: Outbreaks •California (2010) •9,143 cases of pertussis (including ten infant deaths) were reported throughout California. Most cases reported in 63 years. •Measles outbreak source •Ohio (2010-2014) –In 2010, there were 964 cases of pertussis reported by Columbus and Franklin Counties. Most cases reported in 25 years. –In 2014, there have been 377 cases of measles (10 hospitalized) since March. –In 2014, there have been 460 cases of mumps (many Vaccine-Preventable Diseases Issues with Adult Vaccination Busy Practice Costly Inventory Storage and Handling Concerns Frequently Changing Practice Guidelines Lack of System-wide Documentation Inconsistent Reimbursement Patient Objections/Myths Physician-Patient Miscommunication National Foundation for Infecgious Diseases. Surveys of consumers and physicians 2010 The Communications Breakdown Recommendation “You need to get this vaccine.” OR “I want you to get this vaccine.” VaccineMotivated Patient Not a Recommendation “Do you want this vaccine?” OR “Think about getting the vaccine.” VaccineAmbivalent Patient Vaccines: Very high benefit/risk ratio All vaccines have possible side effects, most mild, rarely severe The risk of disease far outweighs the risk of vaccine MESSAGE: Vaccines Effective Need Clear, Unambiguous message Safe Need to recommend 12 Recommended Adult Immunization: 2015 13 2015-2016 U.S. Influenza Vaccine Composition A/California/7/2009 (H1N1) • Unchanged A/Switzerland/9715293/2013 (H3N2) • Change B/Phuket/3073/2013-like virus. • Similar to last year B/Brisbane/60/2008-like virus (in quadrivalent) 15 INFLUENZA VACCINE-Importance Influenza may lead to many complications in adults • secondary pneumonia • exacerbation of underlying disease(i.e., chronic lung or heart disease) Influenza virus changes antigens over time; patients may therefore, not be immune because of prior exposure Efficacy • Depends on: 1. Immunogenicity; 2. Serotype match • Recently varied 20-60% pending patient type Can be given at SAME time as pneumococcal vaccine US Influenza Vaccines Prepared from embryonated chicken eggs inoculated with specific strains of virus IIV: ‘Killed’, injectable “All comers” 6 months and older--Both Trivalent (TIV) and Quadrivalent) IIV Intradermal Approved May 2011 for 18-64 years [smaller needle] All Quadrivalent LAIV: Live-attenuated, cold-adapted nasal (CANNOT replicate at body temperature)-nasal spray very minimal viral shedding; OK to give to nurses unless taking care of severely immunocompromised patients (e.g. Stem cell transplant) Indicated only for healthy people 2-50 years; All Quadrivalent TIV, trivalent inactivated vaccine *Falsey AR et.al. J Infect Dis. 2009;200:172-180. INFLUENZA VACCINE High Dose Fluzone High-Dose Contains 60 mcg each of the 3 Influenza antigens (compared to 15 each for regular TIV) Slightly higher rate of MILD reactions Indications: Patients > 65 years. Costs In large clinical trial had shown high-dose vaccine was 24.2% more effective in preventing influenza in adults > 65 than the standard vaccine. N Engl J Med 2014;371:635-45 Newer Influenza Vaccines (Cell culture) Flucelvax In place of chicken eggs, uses animal cells (Canine Kidney) as host(reference strain obtained form virus originally grown in eggs) Approved ≥ age 18 Flublok Recombinant vaccine (RIV) — egg-free hemagglutinin influenza vaccine produced by recombinant DNA technology using a baculovirus (a virus that infects insects) that produces virus-like particles, hemaglutinin (vaccine of choice for true egg allergy) Approved ages >18; Only 16 week shelf life Adverse events similar to other inactive vaccines INFLUENZA VACCINE Reduction in Hospitalizations for Cardiac disease and Strokes (Nichols et a. NEJM 348, April 3, 2003) Observational studies of large cohorts (140,000; 146,000), ’98-’99 AND ’99-’00, 3 HMOs, age 65 Vaccination against influenza associated with reduction in hospitalization for : Cardiac disease (19% both seasons) Cerebrovascular disease (16%; 23%) Pneumonia and Influenza (32%; 29%) All cause Death (48%; 50%) Possible mechanisms: infection cause alterations in clotting factors, platelet aggregation, amount of inflammatory- response cytokines which enhance thrombosis Similar findings of more recent study (JAMA. 2013;310(16):1711-1720) Adults who get Flu Vaccine help Protect elderly People > 65 years were less likely to have serious influenza-illness when 1/3 of younger adults within their communities were immunized. Cases of influenza-related illness in the elderly could have been prevented if more non-elderly adults had received the flu vaccine. Taksler et al Clin Infect Dis 2015; doi:10.1093/cid/civ630 Influenza ‘Nuts and Bolts’1 Vaccination season: Soon as available to ~April Influenza season unpredictable-can start Oct Immunity will last for almost all patients (no concern for waning immunity for most)) Late season vaccination important and underutilized LAIV can be safely used in MOST healthcare settings as alternative to TIV2 Egg allergy NO LONGER contraindication3 Anaphylaxis is EXCEEDINGLY rare [<10 documented cases] Flublok if concern OK to give egg-based if not history of severe anaphylaxis • If vaccinated, should be observed ~30 minutes in office 1. 2. Centers for Disease Control and Prevention. Inactivated Influenza Vaccine 2011-12. Available at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-flu.pdf Talbot TR, et al. Infect Control Hosp Epidemiol. 2010;31:987-995. Influenza Vaccine and Egg Allergy: ACIP 2013 23 Which vaccine for each patient? Patient Pregnant women 67 y/o diabetic Prior hives with eggs 48 y/o smoker 58 y/o COPD 18 month child Vaccine Trivalent inactive(> 6 months) Trivalent ‘High dose’ inactive (65 +) Nasal ‘live’ vaccine (2-50) Intradermal vaccine (18-64) Quadrivalent inactive (>6 mo) Cell Culture; Recombinant (Flublok) (>18) Cell Culture (canine cell; Flucelvax ) (> 18) 24 Influenza and Pregnancy Pregnant woman at high risk for severe complications and death Cellular immune response diminished Maternal influenza associated with increased (Zaman et al. NEJM 2008) Maternal hospitalization Fetal malformation Other illnesses Prevention is best approach Newborns are at high risk for severe complications Several reports of 2nd MRSA infection No approved vaccine for infants < 6 months of age All care givers need to be free from possible transmission to this vulnerable population Benefits/Obligations of Influenza vaccine for Healthcare providers As HCW we all have an obligation to protect our patients Transmission may occur without illness • May be asymptomatic carriers • Infectious prior to onset of symptoms Studies show reduced transmission after vaccination Protection form acute illness For H1N1 greatest morbidity and mortality is in ‘healthy’ individuals aged 20-50. Protection of family members (especially if very young or with medical conditions) Mandatory immunization of all HCW being implemented at SUMMA 77% of Influenza ‘asymptomatic’ Flu Watch Study1 Course of influenza over 5 cohorts (2006-11) Serology; PCR; Weekly assessment for RTI Findings 77 % appeared to asymptomatic Only 17% of PCR-confrimed infection sought medical attention “A large number of well individuals in the community make a substantial contribution to transmission.”2 1. Hayward et al. Lancet Resp Med. 2014; 2: 445-54; 2. 2. Horby Lancet Resp Med. 2014; 2: 430 Centers for Disease Control and Prevention. 2010. Active Bacterial Core Surveillance Report, Emerging Infections Program Network, Streptococcus pneumoniae, 2009. http://www.cdc.gov/abcs/reports-findings/survreports/spneu09.pdf. Accessed February 3, 2011. Pneumococcal Diseases causes more deaths per year in US than Breast Cancer or Prostate Cancer Xu. Et al. Deaths: Prelimanary data for 2007. Natl Vital Stat Rep. 2009; 58: 1-51 Pneumococcal Vaccines-adults 90 known serotypes of S. pneumoniae Pneumococcal polysaccharide vaccine (PPSV23) Inactive vaccine; contains 23 serotypes which account for majority (75-80%) of clinical disease. Approved for use in adults of any age; ? Efficacy for pneumonia Pneumococcal conjugate vaccine (PCV13) approved for use in adults age 50 and older Inactive vaccine, conjugated with diptheria CRM 197 protein); 13 serotypes which account for approx 45-50% of invasive disease Approval from FDA announced December 30, 2011 for adults 50 years and older Previously approved and recommended for use in children CDC’s Advisory Committee on Immunization Practices (ACIP) recommends use for patients who are immunocompromised PNEUMOCOCCAL VACCINE 13 valent conjugated vaccine study for adults CAPITA Study (Community Acquired Pneumonia Immunization Trial in Adults) RCT trial in Netherlands Design 13 valent conjugate vaccine (same as pediatric vaccine) Placebo controlled (1:1); approx 85,000 subjects, > 65 years of age, community dwelling Endpoints: • Primary-prevention of CAP (serotype specific) • Secondary-all cause CAP, colonization (2000 subjects), mortality, bacteremia RESULTS: 45% reduction in vaccine typed non-bacteremic pneumonia 75% reduction in vaccine type IPD; Bonten MJM et al. N Engl J Med 2015; 372: 1114–1125. Strategies for sequential use of Conjugate and Polysaccharide vaccine use in adults Conjugate vaccine more immunogenicity (higher antibody levels) and can have booster effect 13 serogroups (accounts for approx 50% of invasive cases of pneumococcal disease Polysaccharide vaccine less immunogenecity and NO booster effect (may have hyporesponsiveness) But has 23 serogroups (accounts for approx 89% of invasive cases) Give Conjugate first followed by polysaccharide for potentially optimal effect If polysaccharide given initially wait one year to administer the conjugate vaccine (reduce ? Hyporesponsiveness) 32 33 Source: Designed by National Foundation for Infectious Disease based on CDC recommendations; 2012 Newer CDC Recommendations 2015 for aged > 65 Patient Scenarios 24 year with asthma has not previously received any pneumococcal vaccine 28 year old woman with HIV infection received one dose PPSV23 a year ago. Patient Scenarios 24 year with asthma has not previously received any pneumococcal vaccine PPSV23 now; PCV age 65 followed by PPSV 6-12 months later 28 year old woman with HIV infection received one dose PPSV23 a year ago. Patient Scenarios 24 year with asthma has not previously received any pneumococcal vaccine PPSV23 now; PCV age 65 followed by PPSV 6-12 months later 28 year old woman with HIV infection received one dose PPSV23 a year ago. One dose PCV now (> one year since PPSV); 2nd dose PPSV23 age 32 (> 5 years since PCV); 3rd dose PPSV age 65 Patient Scenarios 42 year old male cochlear implants, no prior vaccines 66 year old male, CHF, received PPSV23 age 55 Patient Scenarios 42 year old male cocjhlear implants, no prior vaccines One dose PCV now; one dose PPSV23 > 8 weeks later; 2nd dose PPSV23 age 65 68 year old male received PPSV23 age 66 Patient Scenarios 42 year old male cochlear implants, no prior vaccines One dose PCV now; one dose PPSV23 > 8 weeks later; 2nd dose PPSV23 age 65 68 year old male received PPSV23 age 66 One dose PCV13 now Pertussis Vaccine: Adults DTaP (Pediatric vaccine) Daptacel™, Infanrix™, Tripedia™ Contains higher concentration of diptheria toxoid and acellular pertussis Tdap = Tetanus and Diptheria Toxoid, and Acellular Pertussis Adacel™ (Sanofi Pasteur); Boostrix™ (GSK) Single dose for persons 11-18 years of age who have completed the childhood series Single dose for adults aged 19 years and older (Including adults 65+ [esp. those with infant contact) Tdap should be administered regardless of interval since the last tetanus-containing vaccine, especially if the patient will have contact with children <12 months of age ACIP Tdap Recommendations Specific Priority Groups Pregnant women at 27-36 weeks' gestation AT EACH PREGNANCY! Adults, regardless of age, who are in close contact with infants younger than age 12 months (e.g., parents, grandparents, or child-care providers) Healthcare Providers Repeat Tdap in Pregnancy Retrospective chohort 29,155 pregnant women; ages 14-49; 2007-2013 Sukumaran L et al. JAMA 2015; 314:1581-87 Zoster Vaccine (Zostavax ™) Live vaccine • Not for pregnancy, immunocompromised Approved for the prevention of herpes zoster (shingles) in persons aged 50 years and older. (CDC ≥ 60) Single SC injection within 30 minutes of reconstitution • In 38,000 patient study, reduced the incidence of shingles by 51% in persons aged 60 years and older (less effective in older patients) • Incidence of postherpetic neuralgia less by 39%. Zoster Vaccine (Zostavax ™) Most common questions What if no history of chicken pox? • OK to give What if past zoster? • Give after resolution of past episode; no specific time interval recommended Is it covered by Medicare • Covered by Part D not Part B. Insurance payment varies by plan. • To be covered by ACA Should I receive if around pregnant or immunosuppressed persons? • YES--not transmitted The wars of the world: Saving lives through vaccination Without the safe and effective vaccines that we too often take for granted now, more than 300 million who lived full and rewarding lives during the 20th century would have died prematurely of a vaccine-preventable disease. Compare this with the 160 million estimated to have been killed in all wars combined during the same century. Stated another way, vaccines saved twice as many lives as were lost in war during the most destructive 100 years in human history. DW Kimberlin Inf Dis News. Aug 1, 2011 Summary New Influenza vaccines Chose based on age, allergy, preference Adult Conjugate pneumococcal vaccine Now wirh specific CDC recommendations Sequential administration with polysaccharide (give conjugate first) CMS will pay for 2 vaccines Tdap For every pregnancy Zoster Will be covered by ACA