Update on Adult Immunization Strategies: Understanding the Current Recommendations

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1 Update on Adult Immunization Strategies: Understanding the Current Recommendations EDWARD A. DOMINGUEZ, MD, FACP, FIDSA Medical Director, Organ Transplant Infectious Diseases Methodist Dallas Medical Center, Dallas, Texas

2 Disclosures Edward A. Dominguez, MD Dr. Dominguez has disclosed that is a consultant for Amgen.

3 Objectives By the end of this activity, the participant should be better able to: Discuss the burden of pneumococcal disease, herpes zoster and influenza, and identify the various patient types who are particularly vulnerable to infection. Describe the latest guideline recommendations for adult immunization. Evaluate strategies to improve adult immunization by incorporating systems in clinical practice to proactively screen patients and administer vaccines according to guideline recommendations. Think critically about the moral and ethical implications of both allowing the refusal of vaccinations, and mandating vaccinations.

4 ACIP Adult Vaccination Schedule

5 ACIP Special Population Adult Schedule

6 Influenza Viruses RNA virus Orthomyxoviridae family Types A & B based on antigenic differences of nucleo- and matrix proteins On the basis of the antigenicity of these glycoproteins, influenza A viruses currently cluster into sixteen H (H1 - H16) and nine N (N1 - N9) subtypes.

7 Circulating Influenza Viruses Seasonal influenza A(H3N2), A(H1N1), B Avian influenza ( bird flu ) A(H5 and H7, e.g. HPAI H5N1) Swine influenza ( swine flu ) -> variant flu A(H1N1v) pandemic strain A(H3N2v) US strain

8 US Influenza Activity,

9 Texas Influenza Activity,

10 US Influenza Activity,

11 Virologic Diagnosis RT-PCR Gold standard; types and subtypes Rapid molecular assays fast; types only Immunofluorescence 1-4 hrs; types and other respiratory viruses Rapid antigen detection 1< 1 hr Culture for epidemiology confirmation Serology for epidemiology only All studies more likely to be positive if collected in first 3 days of illness

12 Antivirals Approved for Influenza

13 Influenza Vaccine Components Trivalent Vaccines A/Michigan/45/2015 (H1N1)pdm09-like virus A/Singapore/INFIMH /2016 (H3N2)-like virus; B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) Quadrivalent Vaccines All the above strains, PLUS B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage)

14 Influenza Vaccine Preparations

15

16 Considerations Regarding Egg Allergy People with egg allergies can receive ANY licensed, recommended age-appropriate influenza vaccine and no longer have to be monitored for 30 minutes after receiving the vaccine. People who have severe egg allergies should be vaccinated in a medical setting and be supervised by a HCP able to recognize and manage severe allergic conditions.

17

18 Streptococcus pneumoniae

19 Pneumococcal Disease Pre-antibiotic era, ~ 75% of CABP In US, now 10-15%, due to vaccine efficacy! Still among most common causes of CABP in adults Over 90 serotypes Up to 50% of adults colonized in nasopharynx during respiratory season Colonization more common in children

20 Risk Factors for Pneumococcal Disease Recent influenza infection Alcoholism Smoking COPD and asthma Hyposplenism Immunosuppression Social factors (e.g. incarceration; homeless)

21 Complications of Pneumococcal Disease Pulmonary Effusions or empyema (5-12%) Necrotizing pneumonia and abscesses Bacteremia now only 1% or less in US Acute cardiac events (19% in Houston VA study) About 4,000 adult deaths in US annually

22 Prognosis Age >65 years Odds ratio (OR) 2.2 Residence in a nursing home OR 2.8 Presence of chronic lung disease OR 2.5 Need for mechanical ventilation OR 4.4 High acute physiology and chronic health (APACHE)

23 Pneumococcal Vaccines Pneumococcal Polysaccharide vaccine (PPSV 23 Pneumovax 23) Licensed for routine use in adults 50 & older and age 2 49 with certain risk factors Pneumococcal Conjugate vaccine (PCV 13 Prevnar) FDA approved for use in adults age 50 and older in December 2011 NOTE: Prevnar 13 is NOT FDA approved for age 18 to 49!

24 Contraindications Pneumococcal Vaccines Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a vaccine component Precautions Moderate or severe acute illness with or without fever

25 Pneumococcal Vaccine Algorithm

26 Medicare Coverage for Pneumococcal Vaccines

27 Pneumococcal Vaccine Indications Age 65 and older COPD Asthma Smokers age CV disease Liver disease Chronic alcoholism DM CSF leaks Cochlear implants Pre-splenectomy Asplenic HIV Immunosuppressed Multiple myeloma/ca HSCT/SOT recipients CKD/nephrotic syndrome Steroid therapy

28 Vaccination of Immunocompromised Risk in immunocompromised is 20x > than immunocompetent ACIP recommended routine PCV 13 conjugate FIRST for immunocompromised adults: (off-label use not FDA approved for adults < 50) Risk of invasive disease in older adults is 10 times higher than in younger adults

29 Vaccination of Immunocompetent Ages 19-64: if certain conditions Chronic medical conditions: PPSV23 only l l Chronic heart disease (not hypertension) Chronic lung disease (including asthma) l l l Chronic liver disease (including cirrhosis & alcoholism) Diabetes Smokers Ages 65 & older: (all) BOTH PCV13 & PPSV23

30 Pneumovax Revaccination Revaccinate once after 5 years only if Sickle cell disease Functional or anatomic asplenia Immunosuppressed Chronic renal failure Nephrotic syndrome Age 65 or older and 1st vaccine given when <65 years old

31 If had chickenpox at risk for shingles 99.5% US adults > 40 y/o have serologic evidence of prior VZV infection One million cases/yr. Lifetime risk: 30% Risk increases with age (starting at age 50) Shingles Facts Harpaz R, et al. MMWR Recomm Report. 2008;57:1-30

32 Clinical Aspects of Shingles Pain prior to rash onset: 84% of cases Starts as abnormal skin sensation, itching or tingling Precedes rash by 1-5 days but occasionally weeks Diagnostic dilemmas & work-ups (e.g., cardiac, gallbladder) Pain once rash develops: 89% of cases

33 Post-Herpetic Neuralgia (PHN) Schmader KE. Clin Infect Dis. 2001;32:1481-6

34 Risk Factors for PHN Gender: Risk greater in women Dermatome: Possibly increased with CN V1 Immunosuppression? : NO Age is the key risk factor for developing PHN Rare in HZ patients <40 years Risk of pain at >30 days: 14.7-fold in HZ patients >50 years Risk of pain at >60 days: 27.3-fold in HZ patients >50 years Risk of pain at >60 days: 12% for each incremental year of age Increasing age increases risk of shingles and risk of progression to PHN

35 Shingles Vaccines Live-virus attenuated (Zostavax) Subunit-adjuvant HZ-su (Shingrix)

36 Live-Virus Shingles Vaccine FDA approved: Age 50+ ACIP/CDC recommends dose at age 60+ Works best in younger age group Reduced shingles risk by nearly 69.8% NOT indicated for treatment of VZV or PHN! NOT indicated for prevention of chickenpox Contraindications: Allergy to components (gelatin, neomycin) Immunosuppression l Prednisone 20 mg/d Pregnancy or planned pregnancy within 3 months

37 Shingles vs. Chickenpox Vaccines Chickenpox vaccine Varivax FDA approved in March 1995 Shingles vaccine Zostavax FDA approved May 2006 Both derived from Oka Merck strain of live attenuated VZV Shingles vaccine is about 10 times stronger

38 HZ/su Subunit Vaccine Randomized, placebo-controlled phase 3 study More than 25,000 patients, age 50 and older Conducted in 18 countries Two injections, at least 1 month apart Study indicated vaccine efficacy of 97.2% More injection site & systemic reactions as compared to placebo Duration of protection exceeds 4 years

39 HZ/su Subunit Vaccine Efficacy Lal H et al. N Engl J Med 2015;372:

40 Lal H et al. N Engl J Med 2015;372: HZ/su Subunit Vaccine Side Effects

41 Risk of Development of Herpes Zoster after Vaccination Cunningham AL et al. N Engl J Med ;375:

42 Risk of Development of PHN after Vaccination Cunningham AL et al. N Engl J Med ;375:

43 Efficacy against the First or Only Episode of Herpes Zoster and PHN Cunningham AL et al. N Engl J Med ;375:

44 Vaccine Reactogenicity and Safety Overall Cunningham AL et al. N Engl J Med ;375:

45 HZ/su Shingles Vaccine CDC recommends TWO doses of Shingrix separated by 2-6 mos for immunocompetent adults 50 y/o: Whether or not they report a prior episode of HZ Whether or not they report a prior dose of Zostavax Who have chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease) l l l Are taking low-dose immunosuppressive therapy Are anticipating immunosuppression Have recovered from an immunocompromising illness

46 HZ/su Shingles Vaccine Who are getting other adult vaccines in the same doctor s visit, including those routinely recommended for adults age 50 y/o It is NOT necessary to screen, either verbally or by laboratory serology, for evidence of prior varicella infection. CDC prefers Shingirx over Zostavax

47 Vaccination Coverage: NHIS 2014 NHIS 2014 data Healthy People 2020 Target Flu 2020 target ( > 19): 70% Zoster 2020 target (> 60): 30% Pneumococcal 2020 target (19-64, high risk) 60% >65: 90% Other NHIS findings: Racial /ethnic differences Higher coverage for whites than most other groups

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