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Adult Immunization: 2013 Update

Adult Immunization: 2013 Update . Robert H. Hopkins, Jr., MD, FACP, FAAP Professor of Internal Medicine and Pediatrics Director, Division of General Internal Medicine Director, Internal Medicine-Pediatrics Residency UAMS College of Medicine. Opportunity and Reward.

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Adult Immunization: 2013 Update

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  1. Adult Immunization:2013 Update Robert H. Hopkins, Jr., MD, FACP, FAAP Professor of Internal Medicine and Pediatrics Director, Division of General Internal Medicine Director, Internal Medicine-Pediatrics Residency UAMS College of Medicine

  2. Opportunity and Reward • Immunization rates are far below goal levels • Commonly identified measure of quality preventive care • Many elements in process which can be ‘attacked’ to make improvements • Front desk • Nursing/MA • Physician • Checkout • Improvement can result in better health for your patients!

  3. Adult Vaccination Rates= POOR! Data: , NFS 2012, NHIS 2011 http://www.cdc.gov/flu/professionals/vaccination/nfs-survey-march2012.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6204a2.htm?s_cid=mm6204a2_e

  4. Goals: 2013 AI Update • Review current ACIP Adult Immunization recommendations • Office/Clinic Practice • Hospital Practice • Healthcare Workers • Quality improvement re: VPD • No discussion of therapeutic and other vaccines

  5. 2013 Adult Schedule [Age-Based]

  6. 2013 Adult Schedule [Disease/Indication Based]

  7. Patients: Office and Hospital “Universals” “Selectives” Pneumococcal [PCV13] Meningococcal Hepatitis A Hepatitis B HPV [HPV4, HPV2] Women Men MMR Varicella • Influenza • Pneumococcal [PPS23] • Tdap • Zoster

  8. Influenza • Influenza: Orthomyxoviridae family [enveloped RNA virus] • 3 types based on surface Ag [HA, NA] + internal structure • A: Multiple hosts- Birds, Mammals [Man]. Many HA , NA types • ‘Highly Pathogenic’ and ‘Mild’ strains • B: Human host. 1 HA and 1 NA • C: Human host. Mild illness ‘URI’ • 30-50K deaths annually in US from Influenza • 200K+ assoc. hospitalizations, chronic illnesses exacerbations • > 90% seasonal influenza morbidity/mortality in persons > 65 years • Vaccination is most effective intervention to reduce illness and death.. • Multiple vaccines avail. in US • Effectiveness variable from year/year, different patient groups http://www.cdc.gov/flu/avian/gen-info/flu-viruses.htm

  9. US Influenza Vaccines • IIV: =‘Inactivated’ and replaces ‘TIV’, IM admin. “All comers” 6 mo.+ • Multiple vaccines varied indications [age, etc.]. 2013-14 most Trivalent--Limited supply of quadrivalent inactivated vaccine expected to be available • IntradermalIIV [Approved May 2011 for 18-64 years--smaller needle] • High-Dose IIV for 65+ population# [first avail 2010-11] • Same production as TIV, higher Ag content ~~ More local reactions • Phase 3 trials: Seroconversion, seroprotection rates > TIV for A,B strains • ‘Real world’ efficacy data not yet published • New Cell culture vaccine approved 2013- option in egg-allergic [2013-14] • NewRecombinant HA Vaccine approved 2013- higher HA content, no NA • LAIV: Live-attenuated, cold-adapted nasal. Quadrivalent [2A2B] 2013-14 Indicated only for healthy people 2-49 yrs. # Falsey, et.al. J ID 2009, June9 [Epub]; C. Bridges CDC Personal Comm. 3/2013

  10. Influenza Vaccine changes annually, recommend yearly vaccination! • Vaccine production: ~9 months • Egg-based [all but new recombinant HA, cell-culture vaccines] • Strain choice (Feb) reflects antigenic drift [Prior season + S. Hemisphere] • US Vaccination season: Vaccine avail. to ‘disease passed’…[Sept-April?] • Predominant strain types [Dz and Vax] since 1977: A H1N1, A H3N2, B • 2012-13 Vaccine strains: • Influenza A/California/7/09 (H1N1)-like virus [Since 2009 Pandemic] • Influenza A/Victoria/361/2011 (H3N2)-like virus • Influenza B/Wisconsin/1/2010-like virus (B/Yamagata lineage). • 2/3 strains changed from 2011-12, likely at least B will change for 2013-14 http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb09/04-1-flu.pdf

  11. Influenza Vaccine Priorities • ALL 6 MONTHS AND OLDER + DON’T WANT THE FLU • HEALTHCARE WORKERS • High risk for disease (symptomatic and asymptomatic) • High risk for transmission • If sick not available to provide healthcare… • PATIENTS @ Highest Risk severe illness/spread • Pregnant women • Newborns and Children < 2 years • Elderly • “Medical Comorbidities” (including Obesity) • Household contacts of high-risk • Long-term care/institutionalized, Crowded living conditions http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-flu.pdf

  12. Influenza ‘Nuts and Bolts’1 http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-flu.pdf http://www.premierinc.com/all/safety/safety-share/12-05-downloads/03-shea-hcw-flu-position-paper.pdf http://www.uptodate.com/contents/influenza-vaccination-in-individuals-with-egg-allergy • IIV: 1 dose for adults • Incl: QIV, TIV, sqTIV, hdTIV, LAIV, ccTIV, rHA(Flublock) • Kids < 9 years, first vaccine season: 2 doses 4+ weeks apart • LAIV can be safely used in MOST HC settings as alt. to TIV2 • Egg allergy: ACIP, AAAI: NO contraindication. • Anaphalaxis EXCEEDINGLY rare [~1 in 4 million doses] • History is key: Hives= higher risk, consider allergy referral • Risk/benefit of disease vs. vaccineusually favors vaccine… • When vaccinating egg-alergic, observe in office ~ 30 minutes

  13. Influenza • Vaccine effectiveness is multifactorial • Match with ‘disease’ strains • Vaccine availability and timing • Patient ‘substrate’: • ‘Healthy young < 65’ @ ~60-80% v. ‘Sick older > 65’@ 30-40% • Ongoing vaccine research • Adjuvants • Newer production methods • Higher Ag content http://www.cdc.gov/flu/professionals/antivirals/index.htm http://www.cdc.gov/flu/professionals/diagnosis/

  14. Pneumococcal • > 2000 Adults 65+ die from invasive Pneumococcal Disease yearly • Primary adult vaccine is purified capsular polysaccharide [PPS23] • 23 types- cause of 88 % bacteremic PNC dz • 60-70% efficacy vs. invasive disease [IPD] • IPD= Pneumococcal meningitis, bacteremia • Does not ‘prevent pneumonia’ • Immunity lasts at least 5 yr. following 1 dose • ROUTINE REVACCINATION ONCE @ 5+ yr. + age 65 ACCEPTED • RECOMMEND SELECTED Revaccination: • Vax > 5 yrs before, AND Asplenia, Immunosupressed, CKD or Nephrotic Syndrome • Local reactions- only common AE http://www.cdc.gov/vaccines/recs/schedules/downloads/adult/2009/adult-schedule-bw.pdf

  15. PPS 23 Vaccine Effectiveness Fine, et.al. ArchivesIM 1994(154): 2666. Hutchinson et.al. CanJFP 1999(45): 2381. Watson, et.al. Vaccine 2002(20): 2166. Conaty, et.al. Vaccine 2004(22): 3214. Dear, et.al. Cochrane DB Syst Rev 2004, Issue 3. Moberley , et.al. Cochrane DB Syst Rev 2008, Issue 1. Moberly, et.al. Cochrane DB Syst Rev 2013, Issue 1. • 7 Meta-Analyses of RCT [Most recent Cochrane 1/2013] • Conclusions inconsistent re: cause specific outcomes • Agreement: REDUCTION in IPD; NO reduction ALL CAUSE mortality, pneumonia • 3 Meta-Analyses of OBS studies • Consistent results: vaccine is effective for prevention of IPD • Recent RCT Results • IPD: Odds ratio [consistent] 0.26 (CI 0.25-0.46) • Pneumonia: Odds ratio [signif. heterogeneity] 0.71 (CI 0.52-0.97) • Mortality: Odds ratio 0.87 (CI 0.69-1.10) • Summary • Data supports PPS to prevent IPD, not compelling for Pneumonia, Mortality

  16. Pneumococcal Recommendations PPS23 is recommended1 for: • Adults 65+ • Cigarette Smokers [Since 2009] • Chronic conditions: • Diabetes • Heart, Lung, Liver, Kidneydisease • Including Asthma [Since 2009] • Immunocompromise[PCV13+PPS Since 2012] • Disease-based: Solid tumor, Hematologic malig, Myeloma, HIV,… • Iatrogenic: Steroids, Organ transplants, BMT, … • Anatomic/functional asplenia [Sickle Cell, etc.][PCV13+PPS Since 2012] • CSF Leak, Cochlear Implant [PCV13+PPS Since 2012] MMWR 2008;57(53). Scott, et.al. Vaccine 25 (2007) 6164-6.

  17. PCV13 Vaccine in Adults NEW 2012 • Routine PCV-13 in US infants since 2010 • 2010 FDA approved + ACIP recommended • All children 6 weeks – 71 months [Series- another talk…] • Dec 30, 2011 FDA approves for adults: • Prevention of pneumonia and IPD ≥ 50 years • Based on immunogenicity studies [not clinical efficacy] • Safety in ~6000 adults similar to PPSV23 • June 20, 2012 [Pub Oct 12, 2012] ACIP recommends PCV13 in adults: • Immune compromised adults ≥ 19 years + CSF leak/cochlear implant • Best practice PCV 13 should be administered before PPS23 • 1 Booster in children 6-18 years with immune compromise ACIP. MMWR. 2012:61:394-395.

  18. PCV 13 Recommended in Adults With: • Solid Organ Transplants • Multiple myeloma • Hematologic malignancy [Leukemia, Lymphoma, Hodgkins] • General Malignancy • ESKD, Nephrotic Syndrome • Sickle Cell, hemoglobinopathy • HIV • Immunosuppression/Immunodeficiency • Not-immune-compromised • CSF leak, Cochlear implant

  19. PCV13 Vaccine in Adults NEW 2012 • Pneumococcal (PPS23) vaccine-naïve patients: • Adults ≥ 19 yrs with immunocompromise, CSF leak/Cochlear implant • PCV13 FIRST followed by PPS23 at least 8 weeks later • Booster PPS23 in 5 years • AND boost PPS 23 after 5 years PLUS 65+ years old • Previously PPS23-vaccinated subjects: • Adults ≥ 19 yrs with immunocompromise, CSF leak/cochlear implant • PCV13 should be given 1+ years AFTER PPSV23 • Booster PPS23 in 5 years • AND boost PPS 23 after 5 years PLUS 65+ years old ACIP. MMWR. 2012:61:394-395; ACIP June 20, 2012.

  20. Td >> Tdap • All patients should have primary Tetanus, diphtheria series • 3 doses: 0, 1 m., 6 m. [Yields protective Ab~ all for 10 yrs+] • Many adults > 60 y. never received primary T, d series • Over 50% adults do not have protective T, d Ab’s • Booster Td every 10 years [Many adults do not receive routine boosters] • Most boosters given are ‘episodic trauma-related’ • Replace 1 dose Td with Tdap [In primary series or as ‘booster’] • Tdap need not wait on 10 year interval from last Td • Td/Tdap Contraindications • Severe allergy to vaccine comp., Arthus reaction after prior Tetanus vax. • [Tdap] Encephalopathy < 7 days after pertussis containing vaccine • [Tdap] Unstable neurologic disease, Moderate-severe acute illness http://www.cdc.gov/vaccines/vpd-vac/combo-vaccines/DTaP-Td-DT/Tdap.htm

  21. Td >> Tdap • Pertussis incidence increasing since 1970’s • 2012: CDC Passive Surveillance US >42,000 cases, likely 10+x higher • Community outbreaks: Most in fall, winter and in persons of all ages • Nosocomial Disease: Academic, Community • [Med/Surg, OR, L&D, NICU, Oncology] • Residential Care • Adults/Adolescents do not have ‘classic’ triphasic disease • Most have persistent Cough: Median 4 months [6 studies] • 20-40 % ‘Whoop’, 40-55 % Posttussive emesis • 12-32 % Lymphocytosis • ~10% develop complications [Pneumonia most common] http://www.cdc.gov/vaccines/vpd-vac/pertussis/ http://www.cdc.gov/vaccines/vpd-vac/combo-vaccines/DTaP-Td-DT/Tdap.htm

  22. Td >> Tdap • Tdap Recommendation: All Adults • Single dose to replace one dose Td [Booster or primary] • Current recommendation: subsequent Td q10yr • Research on repeated dosing ongoing • May give any time (< 10 years) following last Td • 2011: Tdap recommendation extended to adults > 65 years • No data to suggest harm • Research in process re: effectiveness • Special emphasis: adults with close infant contact: • HEALTHCARE, Parents, Child Care, etc. • NEW 2013: Tdapintrapartumall women, each pregnancy • Regardless of interval/prior Tdap [ideal @ 27-35 weeks] http://www.cdc.gov/vaccines/vpd-vac/combo-vaccines/DTaP-Td-DT/Tdap.htm

  23. Zoster • Most who have varicella have measureable Ab for life • Zoster occurs when CMI surveillance declines [theoretical] • Reactivation or Varicella exposure re-stimulates CMI [Cycle repeats] • Lifetime risk of Zoster ~33% [99.5% adults serology + prior Varicella] • At 85- lifetime risk ~ 50% • PHN= most common AE • To 1/3 patients with Zoster • More common • Zoster occurs @ 70+ • Immunocompromised • Vaccination stimulatesCMI • Arvin A. NEJM 2005;352:2266-77. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm

  24. Zoster • Vaccinate60+ adults [ACIP: Not immunocompromised] • FDA approved from age 50 [Coverage? Cost/Bene?] • Regardless of prior Zoster [opinion: wait 1 yr] • No need to test for/vaccinate against Varicella first • Contraindications • Pregnancy • Anaphylactic Hypersensitivity to Neomycin, Gelatin • No need to defer for ‘at risk contacts’- transmission risk low • No need to defer if recent transfusion, Ab containing products • Adverse events • Occasional mild varicella-like rash @ vaccine site • Frozen powdered vaccine: Give within 60 minutes, 0.65 ml SQ Deltoid • Duration of protection: At least 4 years. No booster. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm

  25. Zoster Vaccine Efficacy Trial: • 38,546 Veterans: Median age: 69 years • 60-69: 20,747 [Efficacy greatest in this group] • ≥ 70: 17,799 (46%) • ≥ 80: ~2,500 (6.5%) • Excluded: Immunocompromised, prior zoster, < 60 yrs. • Vaccine group had [v. placebo]: • 51% fewer episodes of zoster • Less severe disease • 66% less postherpetic neuralgia • No significant safety issues were identified Oxman MN et al. NEJM. 2005;352:2271-2284.

  26. Varicella • Varicella, Zoster vaccines from OKA-strain attenuated virus • Varicella 1,350 PFU virus/dose • Zoster 20,000-60,000 PFU virus/dose • Varicella recommendations similar to MMR: 2 doses, live virus • Difference: Non-immune born after 1980 • Risk of vaccination in pregnancy lower than MMR; but neither is recommended: Vaccinate non-immune women postpartum • Risk groups • HEALTHCARE WORKERS (need 2 doses unless immune) • Education, Daycare, Institutional Employees • Women of childbearing age [Vaccinate pre-preg., post-partum] • International travel

  27. MMR, Varicella • Contraindications: • Severe immune compromise • Organ transplant • HIV: CD4 < 200 • Allergy to vaccine component [MMR=Egg, Varicella=Neomycin, gelatin] • Acute/severe illness • Recent transfusion [Any immunoglobulin-containing product] • Active untreated TB • Pregnancy • MMR: not pregnant x 3 months after vaccine- prevent NRS • Varicella: Not major risk but avoiding all live vaccines recommended • Live virus vaccines [Var., MMR, Zoster] and Tb skin test • OK same day, otherwise delay skin test > 3 months http://www.cdc.gov/mmwr/preview/mmwrhtml/00053391.htm

  28. MMR CDC Health Advisory Network: June 22, 2011, 16 :00 EST (04:00 PM EST) CDCHAN-00323-11-06-22-ADV-N http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5733a1.htmhttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm5542a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5753a6.htm • Disease reports increased since 2005…. • Live-attenuated vaccine, routine childhood in most ‘developed world’ • MMR for Adults: 2 doses in non-immune adults born after 1957 • High Risk • HEALTHCARE WORKERS [Born after 1957- Immune or 2 doses] • College Students, [Prison, military barracks, etc.] • International Travelers • Outbreaks assoc. with international travel, adoptions • Immigrants

  29. Hepatitis A, B • Vaccination currently recommended in all US children • Hepatitis A [2007] • Hepatitis B [1995] • Both have selective recommendations for adults • Do NOT need to start over if completion of series is delayed • Can be given individually or together [Combination vaccine] • HAV: 2 doses @ 6+ month interval • HBV: 3 doses @ 0, 1 m, 6 m. • Dose and alternate regimens are different for Hemodialysis patients • Combination: 3 doses @ 0, 1 m, 6 m. • Accelerated Combo.: 4 doses @ 0, 7 d., 21-30 d., booster @ 1 yr. http://www.cdc.gov/vaccines/recs/schedules/downloads/adult/2009/adult-schedule-bw.pdf

  30. Adult Hepatitis A,B Indications • Hepatitis A • Chronic Liver Disease • Including chronic HBV, HCV • MSM • Injection Drug Users • Travel to endemic area • Recipients of Clotting factors • Lab workers • Dialysis HBV • High dose vaccine: all ESRD pt. • Hepatitis B • Diabetes mellitus [12/2011] • Chronic Liver Disease incl. chronic HCV • MSM • Injection Drug Users • Travel to endemic area/intl. adoption • Recipients of Clotting factors • >1 sexual partner/6 mo, STD clinics • HEALTHCARE WORKERS • HIV • Household and sexual contacts of HBV patients • Male prison inmates, correctional staff • Developmental disability facility patients, staff • AK natives and pacific island natives • Any others that want to prevent HBV http://www.cdc.gov/vaccines/recs/schedules/downloads/adult/2009/adult-schedule-bw.pdf

  31. HPV • Cervical Cancer is consequence of a STD [HPV] • Second most common cause CA death in women • 500,000 cases and 250,000 deaths per year • US: ~10 women die every day of cervical cancer • Cause of anal CA and penile CA in men • 20 million current HPV infections • By age 50, 80% SA women will have acquired genital HPV • Many clear spontaneously • 6.2 million new genital HPV infections/year in US • 74% in women 15-24 years of age • 70% Cervical CA worldwide d/t serotypes 16 [54%], 18 [13%] • >90% Genital Warts due to serotypes 6, 11 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm

  32. HPV • Vaccines: • Gardasil [MSD]: Types 6,11,16,18 3 dose series @ 0, 2 m., 6 m. • Cervarix [GSK]: Types 16,18 3 dose series @ 0, 1-2 m, 6 m. • Ideally should finish series with same vaccine begun, but mix is OK… • Effective protection at least 5 years based on published data [ongoing] • Effective only for types patient has NOT previously acquired • HPV 2 or 4 Women 11-12 [9-26]: prevent Cervical CA[Pre-CA], Genital Warts • HPV4 Men 9-26 to prevent anal/penile preCA and CA • Contraindications/Cautions: • Local reaction, bronchospasm reported • Not recommended in pregnancy- no proven AE [administer after delivery] • Immunosupression can reduce efficacy • VACCINE DOES NOT CHANGE CERVICAL CANCER SCREENING RECs! http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm

  33. Meningococcal • Highly-contagious gram-negative bacterial infection • Highest mortality in children < 1 year • Recommended for children @ 11-12, pre-college ‘catch up’ • selective adult recommendation based on risk • 4 Current vaccines: A, C, Y, W-135 [no type B vaccine] • MPS4: Polysaccharide vaccine [SQ, 1 dose +?booster] • Available since 1978, fair efficacy, OK if conjugate not available • MCV4 [3 products]: Conjugate vaccines [IM, 1 dose] • Approved 2005, 2010, 2012 • Preferred for primary vaccination • Selective booster dosing after 5 yrs [e.g. if high risk persists/recurs] • MMWR 2005;54(RR-7)

  34. Meningococcal Indications • All Children 11-12 years • College freshmen who will live in dormitory/commune • Not previously vaccinated or vaccinated >5 years previously • Asplenia [anatomic or functional]: Best to vaccinate pre-splenectomy • Terminal complement deficiencies • HIV: Best response if CD4 > 200 • Travelers to ‘at risk areas’: Sub-Saharan Africa, Dec-June • Required for entry into Saudi Arabia/Mecca during Hajj • Microbiologists with potential occupational Meningococcus exposure • MMWR 2005;54(RR-7)

  35. Healthcare Workers

  36. Healthcare Workers • Key in implementation of Adult Immunization • Education • Multiple studies: MD recommendation  increases patient Vax uptake • Need preventive benefits ‘for themselves’ • Potential source for disease transmission • Patients • Other staff • Communities • Families • Potential for VPD to impair patient care • Adversely affect efficiency • Prevent HCW from working with [their] patients http://www.cdc.gov/mmwr/preview/mmwrhtml/00050577.htm

  37. HCW Vaccination • Annual influenza vaccination • Tdap: All should receive 1 dose • MMR, Varicella: Proof of immunity or 2 doses [each vaccine] • HBV: 3 dose series • Titer 1 month after series; repeat series x 1 if titer < 10 IU • No recommendation for screening titer otherwise

  38. HCW Recommendations Adapted from data located at http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm * Live Virus Vaccines

  39. Special Populations • Hospitalized [Medical] Patients • Influenza [in season], Pneumococcal year-round • Consider ‘family ring’ Tdap, Influenza prior to L&D discharge • Immune Compromise: Maximal ‘non-live’ vaccination • Steroids: Prednisone 20 mg/d equivalent • HIV: CD4 < 200 • Biologic Immunomodulators • Preop Consult • MeningCV, PCV13 then 8+ week PPS23 Pre-Splenectomy • PCV13 then 8+ week PPS 23 Pre-Cochlear implant • Travel • CDC ‘Yellow Book’, Travel Clinics esp. for ‘specials’

  40. Immunization Improvement Strategies • Reminder-Recall • Telephone, E-mail, Text, Post card,.. • Partnering • Local Pharmacy, Health Unit • Team-based Care [Standing Orders] • Front desk—MA--Nurse—MD • Standing orders for vaccination are approved and endorsed by CMS since 2002 • Regular P-D-S-A Cycling • Internal and External reporting

  41. Tools • ACP Adult Immunization Guide • FREE!! I-phone/I-pad App [Available in App store] • Download complete guide [or sections] from ACP website • CDC Adult Immunization Scheduler • http://www.cdc.gov/vaccines/recs/Scheduler/AdultScheduler.htm • CDC/ACIP Recommendations • http://www.cdc.gov/immunizations • http://www.cdc.gov/vaccines/pubs/ACIP-list.htm • IAC Summary of Adult Immuniztion Recs • http://www.immunize.org/catg.d/p2011.pdf • STFM SHOTS Tools for ‘Smart’ Phones • http://www.immunizationed.org/

  42. Thank you for your attention! Questions???

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