Vaccinations: What are the recommendations. Disclaimer 03/19/2019. Harold J. Manley, PharmD, FCCP, FASN Senior Pharmacy Director Dialysis Clinic, Inc.

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1 Vaccinations: What are the recommendations Harold J. Manley, PharmD, FCCP, FASN Senior Pharmacy Director Dialysis Clinic, Inc. Disclaimer None other than I am a Pharmacist. guide 2012.pdf 1

2 Advisory Committee on Immunization Practices Recommendations* ( Ages < 18 yrs old or younger 18yrs child combined schedule.pdf Approved by the Centers for Disease Control and Prevention ( American Academy of Pediatrics ( American Academy of Family Physicians ( and American College of Obstetricians and Gynecologists ( Ages 19 yrs old ult combined schedule.pdf Approved by the Centers for Disease Control and Prevention ( American College of Physicians ( American Academy of Family Physicians ( American College of Obstetricians and Gynecologists ( and American College of Nurse Midwives ( * = updated 2/22/19 2

3 Vaccines Abbreviations Trade names Haemophilus influenzae type b Hib ActHIB Hiberix Hepatitis A vaccine HepA Havrix Vaqta Hepatitis A and hepatitis B vaccine HepA-HepB Twinrix Hepatitis B vaccine HepB Engerix-B Recombivax HB Heplisav-B Human papillomavirus vaccine HPV vaccine Gardasil 9 Influenza vaccine, inactivated IIV Many brands Influenza vaccine, live attenuated LAIV FluMist Quadrivalent Influenza vaccine, recombinant RIV Flublok Quadrivalent Measles, mumps, and rubella vaccine MMR M-M-R II Meningococcal serogroups A, C, W, Y vaccine MenACWY Menactra Menveo Meningococcal serogroup B vaccine MenB-4C Bexsero MenB-FHbp Trumenba Pneumococcal 13-valent conjugate vaccine PCV13 Prevnar 13 Pneumococcal 23-valent polysaccharide vaccine PPSV23 Pneumovax Tetanus and diphtheria toxoids Td Tenivac Td vaccine Tetanus and diphtheria toxoids and acellular pertussis vaccine Tdap Adacel Boostrix Varicella vaccine VAR Varivax Zoster vaccine, recombinant RZV Shingrix Zoster vaccine live ZVL Zostavax CKD and the need to vaccinate The incidence and severity of vaccine preventable diseases is higher in patients with altered immunocompetence, such as patients with CKD. Preventable diseases Influenza, Pneumococcal For CKD patients, all cause infection related hospitalization is 16, 37 and 64% higher as CKD progresses from stage Primarily Pulmonary and Genitourinary Infections Patients with earlier stages of CKD may mount a more robust immune response to vaccination, increasing the chance of vaccine induced immunity. Particularly important for patients who wish to pursue transplant KDIGO and ACIP/CDC recommendations Use inactivated vaccines 1. Dalrymple LS, Katz R, Kestenbaum B, de Boer IH, Fried L, Sarnak MJ, Shlipak MG. The risk of infection related hospitalization with decreased kidney function. Am J Kidney Dis. 2012;59(3):356. Epub 2011 Sep 9. 3

4 Influenza Vaccine Vaccinate end Sept/early Oct 4

5 Influenza vaccination Live (LIAV) contraindicated ALL patients should receive annual seasonal influenza vaccination, as indicated Trivalent Quadrivalent High Dose Trade Name Manufacturer Presentation Egg, Cell culture Thimersol (Y/N) if HA, µg/dose Adjuvanted, or Recombinant yes, mercury (each virus) Yes/No production content Afluria Quadrivalent* Seqirus 0.5 ml prefilled syringe 15 Egg No No 7.5/0.25* ml 5.0 ml multi dose vial Egg No Yes (24.5) 15/0.5 ml Fluarix Quadrivalent GlaxoSmithKline 0.5 ml prefilled syringe 15 Egg No No Quadrivalent IIVs (IIV4s) FluLaval Quadrivalent ID Flucelvax Quadrivalent 0.5 ml prefilled syringe 15 Egg No No Biomedical Corp. of Quebec 5.0 ml multi dose vial 15 Egg No Yes (<25) 0.5 ml prefilled syringe 15 Cell No No Seqirus 5.0 ml multi dose vial 15 Cell No Yes (25) 0.25 ml prefilled syringe 7.5/0.25 ml Egg No No Fluzone Quadrivalent* Sanofi Pasteur 0.5 ml prefilled syringe 15/0.5 ml Egg No No 0.5 ml single dose vial 15/0.5 ml Egg No No 5.0 ml multi dose vial 7.5/0.25* ml 15/0.5 ml Egg No Yes (25) Trivalent IIV (IIV3s) 0.5 ml prefilled syringe 15 Egg No No Afluria* Seqirus 7.5/0.25* ml 5.0 ml multi dose vial Egg No Yes (24.5) 15/0.5 ml Fluad (aiiv3) Seqirus 0.5 ml prefilled syringe 15 Egg Yes No Fluzone High Dose Sanofi Pasteur 0.5 ml prefilled syringe 60 Egg No No (HD IIV3) Quadri valent RIV (RIV4) Flublok Quadrivalent Sanofi Pasteur 0.5 ml prefilled syringe 45 Recombinant No No Virus Flu vaccines Trivalent Quadrivalent Standard Adjuvant High Dose Afluria Fluad Fluzone High Dose Fluzone Quad; Fluarix; FluLaval Flucelvax Quad FLublok A (H1N1)pdm09 15 mcg 15 mcg 60 mcg 15 mcg 15 mcg 45 mcg A (H3N2) 15 mcg 15 mcg 60 mcg 15 mcg 15 mcg 45 mcg B/Yamagata 15 mcg 15 mcg 60 mcg 15 mcg 15 mcg 45 mcg B/Victoria 15 mcg 15 mcg 45 mcg Total antigen exposure 45 mcg 45 mcg 180 mcg 60 mcg 60 mcg 180 mcg Production Method Egg Egg Egg Egg Mammali an cells Recombinant baclovirus 5

6 Flu Vaccine impact on Hospitalizations: FS * DCI clinics *unadjusted 6

7 Hazard Ratio (95% Confidence interval) for time to first hospitalization or death by vaccine type and age groupings flu seasons and Vaccine type Hospitalization Death Quadrivalent (overall) High Dose (overall) Quadrivalent < 65 yr old High Dose < 65 yr old Quadrivalent 65 yr old High Dose 65 yr old FS FS FS FS Ref Ref Ref Ref 0.89 (0.82, 0.97) 0.91 (0.82, 1.00) 1.01 (0.85, 1.21) 1.15 (0.95, 1.39) Ref Ref Ref Ref 0.91 (0.80, 1.02) 0.92 (0.82, 1.04) 0.80 ( ) 1.09 (0.85, 1.41) Ref Ref Ref Ref 0.86 (0.76, 0.98) 0.85 (0.73, 0.98) 1.15 (0.91, 1.45) 1.21 (0.92, 1.59) FS= Flu Season adjusted for age, race, gender, vintage, ESRD cause, albumin, catheter, ESCO Bold text = significant results Pneumococcal Disease Cdc.gov. Published Accessed August 17,

8 Fatality Rate: Pneumococcal Infection Immunize.org. Published Accessed August 21, Adultvaccination.org. resources/pneumococcal cta/older.pdf. Published Accessed August 21, Pneumococcal ESRD Outcomes Nephrol Dial Transplant (2011) 26: Pneumococcal Vaccines Serotypes in PPSV23 and PCV13. Merckvaccines.com. serotypes ppsv23 pcv13. Published Accessed August 21, Pneumovax (PPSV23) Inactivated vaccine Covers 23 serotypes Conjugate vaccine Contraindicated in patients with severe allergy to any component Prevnar (PCV13) Inactivated vaccine Covers 13 serotypes Polysaccharide vaccine Contraindicated in patients with severe allergy to any component containing or diphtheria toxoid (DTaP) 8

9 Recommended Pneumococcal Vaccine Schedule Cdc.gov. vaccine timing.pdf. Published Accessed August 17, Common Questions I m not sure of my vaccination status! Persons with uncertain or unknown vaccination status should be vaccinated Can the vaccine cause pneumococcal disease? No Inactivated vaccines containing only a portion of the bacteria Why is PCV 13 recommended to be given first? Immune response to the vaccine when given in this sequence Can I give pneumococcal vaccine with influenza vaccine? Can administer either pneumococcal vaccine (PCV13 or PPSV23) during the same visit with influenza vaccination Administering Pneumococcal Vaccine For Providers CDC. Cdc.gov. nistering vaccine.html. Published Accessed August 21, Ask the Experts: Pneumococcal Vaccines. Immunize.org. Published Accessed August 21, Common Questions I got vaccinated but still got pneumonia, does that mean it didn t work? No, pneumonia may be caused by other things including viruses or fungus Doesn t protect against all serotypes (>90) How many total pneumococcal vaccines should our patients get? Maximum of 4 (3 PPSV23 and 1 PCV13) Antibiotics/infection/steroids/immunosuppression? Moderate or severe acute illness with or without fever is a precaution Not a contraindication Use of every opportunity to administer appropriate vaccines is critical ACIP Contraindications Guidelines for Immunization Recommendations CDC. Cdc.gov. recs/contraindications.html. Published Accessed August 21,

10 It s Complicated! J Am Board Fam Med January February 2018 vol. 31 no Intermittent nurse reminder Monthly nurse reminder Hepatitis B 10

11 Hepatitis B High transmission risk (contaminated surfaces) DOPPS cohort, mean HBV facility prevalence was 3% with a median of 1.9%. the HBV prevalence was >5% in 21.5% of the studied facilities Responders to hepatitis B vaccination have 20% higher survival rate and lower hosp days (10.4 ± 2 vs 32 ± 14 days, P =.03) Vaccine Dose Volume Schedule Recombivax HB 40 mcg 1 ml 0, 1, 6 months Engerix B 40 mcg 2 x 1 ml at one site 0, 1, 2, 6 months Heplisav B 20 mcg 0.5 ml 0, 1 months Schillie S, Harris A, Link-Gelles R, Romero J, Ward J, Nelson N. Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. MMWR Morb Mortal Wkly Rep 2018;67: Factors affecting HBV vaccine seroconversion Age CKD Stage Hepatitis C Obesity Dialysis vintage Albumin < 3.5 g/dl Vit D deficiency Diabetes Hemodialysis International 2005; 9: Dynavax Technologies Corporation. 11

12 Herpes Zoster Incident ESRD patients from 2006 to Determined 2 year mortality following an inpatient diagnosis Sample size individuals, 2784 patients (1.3%) had a zoster diagnosis 1420 patients died (51%) <2 years, mean 8.1 months. older age (adjusted hazard ratio 1.03), malnutrition (1.31), bacteremia/septicemia (1.16) increasing Charlson Comorbidity Index (1.10) 12

13 In summary, irrespective of whether zoster alone worsens mortality, or is simply a marker for decreased survival, its presence in hospitalized dialysis patients portends a poorer prognosis and necessitates clinical awareness of an increased risk for mortality. The impact of zoster vaccination on disease development and mortality rates remain undefined, but early results are encouraging. Clinical Kidney Journal, 2019, vol. 12, no. 1, Clinical Infectious Diseases 2015 Herpes Zoster Vaccines 1. Zoster vaccine live (ZVL, Zostavax) (available since 2006). 2. Recombinant zoster vaccine (RZV, Shingrix), (available since 2017) Recommended by ACIP as the preferred shingles vaccine. Recombinant zoster vaccine (RZV) Dosage and Schedule adults 50 years = 2 dose series (0.5 ml each), 2 to 6 months apart (0, 2 6 months). If > 6 months since the first dose, administer the 2 nd dose as soon as possible. If < 4 weeks after the first dose, the 2 nd dose invalid. 13

14 Common Vaccine Side Effects Injection site pain, redness, Headache Fever Nausea Muscle Tiredness Other ache and swelling Influenza X X X X X X Hoarseness; sore, red or itchy eyes Zoster live X X Zoster recombinant X X X X X X Shivering Pneumococcal X X Hepatitis B X X Questions? Harold.Manley@dciinc.org office mobile 14