10/4/2014 DOES YOUR IMMUNIZATION KNOWLEDGE NEED A BOOSTER?: UPDATES FOR 2014 OBJECTIVES CASE 1 IMMUNIZATION PRINCIPLES CASE 2

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1 DOES YOUR IMMUNIZATION KNOWLEDGE NEED A BOOSTER?: UPDATES FOR 2014 Brandon Dionne, PharmD PGY2 Pharmacy Resident In Infectious Diseases University Of New Mexico College Of Pharmacy OBJECTIVES Explain general immunization principles Describe new Advisory Committee on Immunization Practices (ACIP) recommendations for 2014 Identify contraindications and possible adverse reactions associated with the vaccines discussed Differentiate between appropriate and inappropriate reasons for deferment of vaccinations CASE 1 A 28yo F healthy pharmacy student with no significant PMH is starting clinical rotations. She will need a number of vaccinations, including: Tdap Hepatitis A/B Influenza She started the hepatitis A/B series two years ago. The pharmacist at the student health center should: A. Administer Tdap, hepatitis A/B #2, and influenza. B. Administer Tdap, influenza, and restart the hepatitis A/B series. C. Administer Tdap, hepatitis A/B, but wait to administer the live influenza vaccine. D. Administer only one vaccine. Simultaneous administration is not recommended. IMMUNIZATION PRINCIPLES Type of immunization Vaccine Inactivated Live attenuated Toxoid Host response Administration and storage IMMUNOLOGIC EFFECT OF DTaP vs DTwP CASE 2 DTaP s immunologic effect wanes 1 DTaP cohort has higher incidence of pertussis 2 RR = 2.54 (1.02, 6.36) Lower incidence of adverse effects NA is a 40yo F who was diagnosed with rheumatoid arthritis 10 months ago. She was switched from combination DMARD therapy to rituximab 1 month ago. She received her last tetanus, pneumococcal, and flu vaccines 1 year ago. She is interested in receiving her influenza vaccine at the infusion clinic today. What would you recommend for this patient? A. Intranasal influenza vaccine (LAIV4) B. Intramuscular influenza vaccine (IIV3 or IIV4) C. Either A or B D. Do not vaccinate 1. CDC. MMWR Morb Mortal Wkly Rep. 2012:61(28); Liko, et al. N Engl J Med. 2013:386(6);

2 CONTRAINDICATIONS TO LIVE VACCINES VACCINE STORAGE AND HANDLING Valid Malignancy, radiation, chemotherapy Immunosuppressive therapy >20mg/d of prednisone TNF and non-tnf biologics (e.g. infliximab, rituximab) 1 HIV adult patients with CD4<200 cells/mm3 Children with CD4 cell count percentage of <15% Pregnancy Not recommended for patients who have recently received a transfusion or other blood products Invalid Mild disease low-grade fever, URI, otitis media, mild diarrhea Antibiotic therapy Breastfeeding Premature birth Pregnancy or immunosuppression in household Warfarin Frozen: -58 F to +5 F (-50 C to -15 C) Live vaccines (i.e., Varicella, Zoster, MMR) Refrigerated: 35 F to 46 F (2 C to 8 C) Inactivated vaccines Storage and handling errors Reduced potency and efficacy Increased cost in wasted vaccine It is better to not vaccinate than to administer a mishandled vaccine 1. Singh, et al. Arth Care & Res. 2012;64: WHEN TO ADMINISTER 2014 ADULT IMMUNIZATION SCHEDULE Do not administer before the minimum age Do not administer before the minimum interval between doses Do not restart series Additional time between immunizations does not significantly reduce immunogenicity Co-administration of vaccines does not overload the immune system Some vaccines may reduce efficacy of other vaccines and should be separated If live vaccines are not administered together, separate by 4 weeks ADULT IMMUNIZATIONS BY MEDICAL INDICATION INFLUENZA VACCINE Same strains as last season Influenza A/California/7/2009 (H1N1)-like virus Influenza A/Texas/50/2012 (H3N2)-like virus Influenza B/Massachusetts/2/2012-like (Yamagata lineage) virus Quadrivalent also has influenza B/Brisbane/60/2008-like (Victoria lineage) virus 2

3 MULTIPLE TYPES OF VACCINE INFLUENZA INFECTIONS BY TYPE AND DATE Egg-based Live attenuated (LAIV) 2-49 years of age Inactivated (IIV) Standard dose IM >6 months of age High dose IM 65 years of age Standard dose ID years of age Non egg-based Cell culture (cciiv) 18 years of age Still contains some egg protein Recombinant (RIV) years of age Expiration date is 16 weeks Able to be produced more quickly INFLUENZA RECOMMENDATIONS Changes for 2014 Patients age 2-8 years should receive LAIV Patients age >6 months should receive seasonal flu vaccine Patients age 65 years may receive high dose IIV Children who have never received influenza vaccination need two doses HIGH DOSE INFLUENZA VACCINE Age >65yrs have 50-75% lower antibody titer relative to younger, healthy adults 60 mcg of hemagglutinin antigen per flu strain (standard: 15 mcg) High-dose associated with higher post-vaccine antibody Recent study evaluating clinical benefit for 65 yrs 1 2-season study, > 30,000 participants Fluzone High-Dose 24.2% more effective in preventing influenza in adults 65 yrs Suggested consistent clinical benefit across study years, flu virus types, clinical illness definitions, and lab methods for flu confirmation 1. DiazGranados, et al. N Engl J Med. 2014;371(17):

4 VACCINATION DURING PREGNANCY CASE 2 113,331 eligible pregnancies in Norway from % received influenza vaccine Vaccination during pregnancy substantially reduced the risk of influenza (AHR 0.3; 95% CI ) Risk of fetal death was increased among pregnant women with a clinical diagnosis of influenza (AHR 1.91; 95% CI ) Vaccination was not associated with increased fetal mortality and may have reduced the risk of influenza-related fetal death during the pandemic NA is a 40yo F who was diagnosed with rheumatoid arthritis 10 months ago. She was switched from combination DMARD therapy to rituximab 1 month ago. She received her last tetanus, pneumococcal, and flu vaccines 1 year ago. She is interested in receiving her influenza vaccine at the infusion clinic today. What would you recommend for this patient? A. Intranasal influenza vaccine (LAIV4) B. Intramuscular influenza vaccine (IIV3 or IIV4) C. Either A or B D. Do not vaccinate Haberg SE, et. al. N Engl J Med 2013;368: CASE 3 A physician would like to give a 27yo pregnant female in her second trimester a flu shot. Which formulation would you recommend? A. Live attenuated influenza vaccine (LAIV4) B. Inactivated influenza vaccine (IIV) with preservative C. IIV without preservative D. Recommend waiting until after delivery E. Answer B or C CASE 4 59 year old female requests the shingles vaccine. She has PMH of DM. She denies ever having chickenpox. What would you recommend? A. Obtain varicella antibody blood test B. Administer the shingles vaccine today C. Administer the chickenpox vaccine today D. Administer the shingles vaccine when the patient turns 60 E. Patient does not need vaccine VARICELLA Varicella (Varivax) two-dose series recommended for all patients without documented immunity Not Recommended if: Documentation of two doses of varicella vaccine at least 4 weeks apart US-born before 1980 (except healthcare personnel and pregnant women) History of chickenpox or shingles based on diagnosis or verification by a healthcare provider Laboratory evidence of immunity or confirmation of disease ZOSTER Herpes zoster (Zostavax) recommended for patients 60 years of age FDA approved for 50 years of age Reduced shingles incidence by 51% and postherpectic neuralgia by 67% More effective in yr group (64%) vs. >70 yrs (38%) No screening for prior history of chickenpox Update: Concurrent administration of zoster and PPSV23 does not effect vaccine efficacy 4

5 CASE 4 CASE 5 59 year old female requests the shingles vaccine. She has PMH of DM. She denies ever having chickenpox. What would you recommend? A. Obtain varicella antibody blood test B. Administer the shingles vaccine today C. Administer the chickenpox vaccine today D. Administer the shingles vaccine when the patient turns 60 E. Patient does not need vaccine 20yo male presents to the pharmacy and reports that his girlfriend has just undergone a LEEP procedure. He is interested in the HPV vaccine. What is your recommendation? A. Vaccinate him with Gardasil B. Vaccinate him with Cervarix C. Vaccinate with either Cervarix or Gardasil D. Do not vaccinate because the HPV vaccine is not indicated in males HUMAN PAPILLOMA VIRUS VACCINES Gardasil (HPV4) Inactivated vaccine Covers: strains 16 & 1 8 (cervical cancer) strains 6 & 11 (genital warts) Cervarix (HPV2) Inactivated vaccine Covers: strains 16 & 1 8 (cervical cancer) Approved for use in females & males 1 ages 9-26 Approved for use in females ages injections at 0, 2, and 6 months 3 injections at 0, 1, and 6 months Efficacy 98% Efficacy 98% Lower titers of HPV-16 and HPV-18 2 Higher titers of HPV-16 and HPV-18 2 HPV VACCINES Do NOT treat existing HPV infections Cervical cancer screen recommendations have not changed Not recommended during pregnancy Do not need to test for pregnancy prior to administration If later found to be pregnant, complete series after pregnancy ends 1. CDC. MMWR Morb Mortal Wkly Rep. 2010;59: Einstein, et al. Hum Vaccine. 2009;5: CASE 5 20yo male presents to the pharmacy and reports that his girlfriend has just undergone a LEEP procedure. He is interested in the HPV vaccine. What is your recommendation? CASE 6 26yo female presents to your pharmacy requesting her second dose of HPV. She received her first dose when she was 23 and has a PMH of HPV (strain unknown). She has NKDA. What is your recommendation? A. Vaccinate him with Gardasil B. Vaccinate him with Cervarix C. Vaccinate with either Cervarix or Gardasil D. Do not vaccinate because the HPV vaccine is not indicated in males A. Do not immunize due to lack of efficacy B. Restart the series with Gardasil C. Restart the series with Cervarix D. Continue series with Gardasil or Cervarix 5

6 Number of Cases /4/2014 CASE 7 Td/Tdap A 22yo female is picking up her asthma inhalers, albuterol and fluticasone. She has no other significant medical history. Additional medications include norethindrone/ethinyl estradiol for oral contraception. Her vaccination history includes: Up-to-date with childhood vaccines Td at 17 years of age Inactivated influenza last year Completed HPV series 2 years ago Which of the following vaccinations should the patient receive at her next Family Medicine Clinic visit? A. Influenza B. Pneumococcal C. Tdap D. All of the above E. Answers A and B Single dose of Tdap vaccine for previously unvaccinated individuals 11years of age Regardless of timing of last Td Td booster every 10 years Pregnant women should receive Tdap during each pregnancy (27-36 weeks gestation) Independent of interval since last Td or Tdap PERTUSSIS CASES IN NEW MEXICO FUTURE OF PERTUSSIS VACCINES Year Increased reporting Improved testing methods Change in type of vaccine Reduced vaccine uptake Altered Bordetella pertussis phenotype Postmarketing effectiveness data confirm efficacy estimates for DTaP for preventing pertussis in short term Progressive decrease in vaccine effectiveness with each yr after 5 th dose of DTaP (early waning of protection) Working Group Meeting on Pertussis, 3/2013 Changes to vaccination schedules with already licensed vaccines Development of acellular pertussis-only vaccines for additional doses Consideration for development of new vaccines with longer protection Farizo, et al. J Infect Dis. 2014; 209(suppl 1):S PNEUMOCOCCAL VACCINE Pneumococcal Conjugate Vaccine (PCV13) Inactivated vaccine T-cell-dependent response Pneumococcal Polysaccharide Vaccine (PPSV23) Inactivated vaccine T-cell-independent response Conjugated to nontoxic diphtheria toxin to Poor immune response in children < 2 years of age. improve immunologic response in children <2 years of age. 3-dose series with booster at 12 months. Certain high risk groups receive 1 dose followed by PPSV23 8 weeks later. No special contraindications 1 dose recommended at 65 years old. High-risk patients may receive 2 doses between the ages of Five years between doses is recommended. No special contraindications PNEUMOCOCCAL VACCINE INDICATIONS PCV13 and PPSV23 Meningitis risk Cochlear implants CSF leak Adults 65 yo who have not previously received PCV13 PCV13 and 2 Doses of PPSV23 Immunocompromised Chronic renal failure HIV Malignancy Functional or anatomic asplenia (including sickle cell disease) PPSV23 should be administered 8 weeks after PCV13 PCV13 should be administered at least 1 year after PPSV23 Second dose of PPSV23 should be at least 5 years after first dose PPSV23 Adults 65 yo who have previously received PCV13 Chronic conditions Diabetes Chronic lung diseases (COPD and asthma) Cardiovascular disease Chronic liver disease Nursing home residents Smokers 6

7 OPPORTUNITIES FOR INPATIENT PHARMACISTS SCREENING BY PHARMACISTS Half of hospitalized patients have >1 indication(s) for pneumococcal vaccination 1 <5% vaccinated during hospitalization 1 ~60% of patients hospitalized with serious pneumococcal infections have been hospitalized in the previous three to five years 2 Pilot program at Wake Forest University Baptist Medical Center >450 (90%) patients admitted to medicine service in a one-month period evaluated for pneumococcal vaccine indication by pharmacists 29% of all patients were vaccinated Only 7% of patients in same month period one year prior 68% of patients with indication were vaccinated 1. Bratzler, et al. Arch Intern Med. 2002;162: Kyaw, et al. Am J Prev Med. 2006;31: Noped, et al. Am J Health-Syst Pharm. 2001;58: CHANGES IN INVASIVE PNEUMOCOCCAL DISEASE (IPD) INCIDENCE RATES PCV7 significantly reduced rates of IPD in patients <5 and 65 1 PCV13 reduced IPD hospitalizations as compared to PCV7 2 59% in patients <5 years old 25% in adults CAPiTA STUDY Clinical study to evaluate efficacy of PCV13 for prevention of vaccine-type pneumococcal pneumonia and/or IPD Conducted in the Netherlands Parallel group, randomized, placebo-controlled trial PCV13 vs. placebo Almost 85,000 adults 65yrs 1 o objective: prevention of a first episode of vaccine serotype pneumococcal CAP 2 o objectives: Prevention of first episode of nonbacteremic/noninvasive (NB/NI) VT CAP Prevention of a first episode of VT-IPD 1. Pilishvili T et al. J Infect Dis. 2010;201: Klugman K, et al. IDWEEK. 2013; abstract LB3. (BinaxNOW assay) and/or a Pfizer-proprietary urinary antigen binding assay (serotype-specific urinary antigen detection assay, UAD). 4,6 Full details of the UAD assay have been published. 8 The primary and secondary efficacy endpoints were met (Table 1). Vaccine efficacy is statistically significant, and the protocol defined criterion for this objective (lower bound of confidence interval CAPiTA (CI) > 0) was STUDY reached. 5,6 RESULTS Table 1: Vaccine Efficacy for the Primary and Secondary Endpoints, per protocol population 6 Total Episodes in Episodes in Vaccine Endpoint Number of PCV13 Placebo Efficacy Episodes group group P value (N=42,240) (N=42,256) (95% CI) Primary 1 st episode of confirmed VT % CAP (21.82,62.49) Secondary 1 st episode of confirmed NB/NI % VT-CAP (14.21,65.31) 1 st episode of VT-IPD % (41.43, 90.78) VT= vaccine type ; CAP: pneumococcal community acquired pneumonia; NB/NI=nonbacteremic, noninvasive; IPD=invasive pneumococcal disease; CI= confidence interval; N=total number who received vaccine Serotype-specific efficacy for the vaccine serotypes for the primary endpoint (VT-CAP) is shown in Figure 1. This was a post hoc analysis, the study was not powered to demonstrate serotype-level CASE 7 A 22yo female is picking up her asthma inhalers, albuterol and fluticasone. She has no other significant medical history. Additional medications include norethindrone/ethinyl estradiol for oral contraception. Her vaccination history includes: Up-to-date with childhood vaccines Td at 17 years of age Inactivated influenza last year Completed HPV series 2 years ago Which of the following vaccinations should the patient receive at her next Family Medicine Clinic visit? A. Influenza B. Pneumococcal C. Tdap D. All of the above E. Answers A and B 7

8 MENINGOCOCCAL VACCINE Haemophilus influenzae Quadrivalent conjugated: MenACWY-D (Menactra) or MenACWY-CRM (Menveo) Single dose First-time college students years of age living in residence halls Microbiologists routinely exposed to Neisseria meningitidis (revaccinate every 5 years while exposure remains) Military recruits,travelers to endemic regions, patients at risk during an outbreak Two doses, 8 weeks apart, then every 5 years Patients with functional or anatomic asplenia Patients with persistent complement component deficiencies Quadrivalent polysaccharide: MPSV4 (Menomune) Patients 56 years of age who are only expected to receive one dose (e.g., travelers) Gram-negative bacteria Encapsulated (typeable) and unencapsulated (nontypeable) Six polysaccharide capsule types (a-f) Type b causes 95% of invasive infections Colonizes upper respiratory tract Transmitted person-to-person Respiratory droplets Direct contact with respiratory secretions CDC. MMWR Morb Mortal Wkly Rep. 2014;63(1):1-14. Hib VACCINE ISSUES IN ADULT VACCINATION Added to adult ACIP recommendations for 2014 Splenectomy: 14 days prior to elective splenectomy suggested Some experts recommend vaccination even if immunized Asplenic patients: if unimmunized, 1 dose Recipient of hematopoietic stem cell transplant Regardless of previous vaccination history for Hib Revaccination 6-12 months after successful transplant (3-dose regimen, 4w apart) Vaccination rates among adults continues to be low Barriers include Lack of healthcare provider and patient knowledge about vaccination need (health & high-risk) HCPs offering few or no vaccines recommended Payment for vaccines complicated Medicare sets limits on coverage of vaccines based on plan type Out-of-pocket costs to patients are a barrier CDC. MMWR Morb Mortal Wkly Rep. 2014;63(1):1-14. RESPONSIBILITY OF PHARMACISTS Promote vaccination Be a role model make sure that you are up to date on all your immunizations! Screen patients for vaccination status and indications whenever possible Observe correct timing and appropriate intervals of vaccinations Follow contraindications and precautions Ensure proper storage and administration CASE 1 A 28yo F healthy pharmacy student with no significant PMH is starting clinical rotations. She will need a number of vaccinations, including: Tdap Hepatitis A/B Influenza She started the hepatitis A/B series two years ago. The pharmacist at the student health center should: A. Administer Tdap, hepatitis A/B #2, and influenza. B. Administer Tdap, influenza, and restart the hepatitis A/B series. C. Administer Tdap, hepatitis A/B, but wait to administer the live influenza vaccine. D. Administer only one vaccine. Simultaneous administration is not recommended. 8

9 CASE 8 CONCLUSIONS A 71yo woman is admitted for a COPD exacerbation in October. She received the influenza vaccine last year. Her last Td vaccine was at age 65. Her PPSV23 was given at age 60. She has not received the zoster vaccine, but she had an episode of severe zoster infection 5 years ago. Which vaccines should she receive? A. Influenza B. Influenza and PPSV23 C. Influenza, PPSV23, and Tdap D. Influenza, PPSV23, Tdap, and zoster Immunization efficacy is dependent on vaccine type, patient factors, and proper administration and storage It is important to know indications and contraindications for immunizations The CDC website and ACIP schedule and recommendations are excellent source of information Pharmacists can help to improve immunization status of our patients 9