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1 Shingles Vaccines: What You Need to Know Wednesday, December 6, :00 PM ET In Case of Technical Difficulties If you hear an echo: Make sure you are only logged in once on your computer Select one form of audio only (either computer speakers or telephone connection) If the audio is choppy: Press pause in the top left corner of your screen Wait 10 seconds and then click the play button Dial at any time for live assistance 1

2 Agenda Agenda Welcome and Introductions William Schaffner, MD NFID Medical Director Professor of Preventive Medicine and Infectious Diseases, Vanderbilt University School of Medicine Shingles Vaccines: What You Need to Know Edward A. Belongia, MD Director, Center for Clinical Epidemiology & Population Health Marshfield Clinic Research Institute Marshfield, WI Michael D. Hogue, PharmD Associate Dean, Center for Faith and Health Professor of Pharmacy, McWhorter School of Pharmacy Samford University Birmingham, AL Questions and Answers This webinar is supported by an unrestricted educational grant from Merck & Co., Inc. NFID policies restrict funders from controlling program content. General Information Please note that today s webinar is being recorded All phone lines will be placed on mute throughout the program To hear audio: Computer: Follow directions Phone: ; Access Code After the presentations, there will be a Question and Answer period Use the Chat box on the lower left side of your screen to type your question At the end of the webinar, participants will be directed to an online evaluation Following the webinar, all registered participants will receive an with a link to the presentation slides 2

3 CME/CNE Credit & Webinar Evaluation The National Foundation for Infectious Diseases (NFID) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians. NFID designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit TM. This continuing nursing education activity was approved by the Ohio Nurses Association, an accredited approver by the American Nurses Credentialing Center s Commission on Accreditation (OBN ). This education activity has been approved for a maximum of 1.o contact hour. To receive credit or contact hours, you must complete the online evaluation and pass the post-test with a score of 80% or higher Online evaluation and post-test will be available following the webinar at: Certificate will be available for print or download following successful completion of online evaluation and post-test until December 6, 2018 Disclosures Marla Dalton (NFID staff, content reviewer) owns stock, stock options, patent, or other intellectual property from Merck & Co., Inc. Michael D. Hogue (presenter) serves as an advisor or consultant for GlaxoSmithKline; received grant or research support from Merck & Co. Inc.; and serves as a speaker for Pfizer Inc. William Schaffner (NFID medical director, moderator) served as an advisor or consultant for Dynavax, Merck & Co., Inc., Pfizer Inc., Seqirus, and SutroVax All other speakers, activity planners/reviewers, and staff for this activity have no relevant financial relationships to disclose 3

4 Learning Objectives At the conclusion of this webinar, participants will be able to: Describe the epidemiology and the burden of shingles disease in US adults Discuss ACIP recommendations for use of zoster vaccines in US adults Understand the scientific evidence used by ACIP in making recommendations for zoster vaccination of US adults Describe vaccine storage and handling, dosing, and administration for FDA-approved zoster vaccines Identify strategies for implementation of ACIP recommendations into practice ACIP: Advisory Committee on Immunization Practices About NFID Non-profit 501(c)(3) organization dedicated to educating the public and healthcare professionals about causes, prevention, and treatment of infectious diseases across the lifespan Reaches consumers, healthcare professionals, and media through: Coalition-building activities Public outreach initiatives Professional educational programs (ACCME accredited with commendation) Scientific meetings, research, and training Longstanding partnerships to facilitate rapid program initiation and increase programming impact Flexible and nimble organization 4

5 Pathophysiology and Epidemiology of Herpes Zoster Michael D. Hogue, PharmD Associate Dean, Center for Faith and Health Professor of Pharmacy, College of Health Sciences McWhorter School of Pharmacy, Samford University Herpes Zoster Just the Facts Varicella Zoster Virus remains dormant following primary infection (chickenpox) for decades until reactivation occurs 1 out of every 3 people will develop shingles in their lifetime Most people only have 1 episode in their lifetime; although a second or third episode is possible Estimated 1 million cases per year in the US About half of all cases of shingles occur in individuals > age

6 Risk Factors for Herpes Zoster Increasing age Immunosuppression (including immunosuppressive medications) Gender: Increased risk in females Race: Risk in African Americans less than half that of Whites Trauma or Surgery in the affected dermatome Early Varicella (in utero, infancy): increased risk of pediatric zoster MMWR: 6

7 Herpes Zoster Rash Brief (unappreciated) erythematous, macular phase Papules Vesicles appear within 1 to 2 days and continue to appear for 3 to 4 days Lesions tend to be grouped; tend to cluster where there are branches of the cutaneous sensory nerve (e.g., parasternal, mid-axillary, and paraspinous) 7

8 Rash Pustulation of vesicles begins within a week of the onset of rash Crusts begin to form within 3 to 5 days after pustulation; ulcerations may occur before crusting; crusts gone by 3 to 4 weeks Less than 20% of patients have significant systemic symptoms - fever, headache, malaise, or fatigue Acute Herpes Zoster, T5 Dermatome 8

9 Herpes Zoster Rash Photo provided courtesy of Dr. Kenneth Schmader, Associate Professor of Medicine Geriatrics, Duke University School of Medicine Herpes Zoster-Associated Pain May persist, appear, change character Origin not only from ganglionitis, but also from skin necrosis Persisting pain is from ganglionic damage and misinterpretation of normal skin sensations as being painful (allodynia) Pain for >90 days after rash healing is defined as postherpetic neuralgia (PHN) 9

10 Consequences of Herpes Zoster Acute pain Complications Chronic pain Eye involvement Depression Others Loss of work Loss of independence Medical and indirect costs 10

11 Complications Post-herpetic neuralgia Most common = function of age Ocular complications 15% of HZ = ophthalmic branch 50% associated with eye abnormalities Scarring Bacterial superinfection Encephalitis/motor neuropathies = uncommon Ophthalmic Zoster Photo provided courtesy of Dr. Kenneth Schmader, Associate Professor of Medicine Geriatrics, Duke University School of Medicine. 11

12 Impact of Post-Herpetic Neuralgia on Quality of Life in Older Adults Physical Chronic fatigue Anorexia Weight loss Physical inactivity Insomnia Social Decreased social gatherings Change in social role Psychological Depression Difficulty concentrating Potential caregiver burden Functional Interfere with basic and instrumental activities of daily living Dressing, Bathing, Eating, Mobility Traveling, Cooking, Housework, Shopping Source: Schmader KE. Clin Infect Dis. 2001;32(10): Don t Let Shingles Interfere With Your Life 12

13 New ACIP Recommendations for Herpes Zoster Vaccines Edward A. Belongia, MD Director, Center for Clinical Epidemiology & Population Health Marshfield Clinic Research Institute Live Attenuated Zoster Vaccine (Zostavax ) Merck Licensed in 2006 Efficacy 51% against HZ HZ efficacy ~35% for age 70+ Waning immunity over 1-2 years Efficacy 67% for PHN Low uptake (~30%) Contraindicated in people with immunosuppression 13

14 Previous ACIP Recommendation for Prevention of Herpes Zoster Routine vaccination of adults 60 years of age with Zostavax Zostavax licensed for age years but not recommended due to uncertain long-term protection Adjuvanted Recombinant Zoster Vaccine (Shingrix ) GSK Recombinant glycoprotein E subunit New AS01 adjuvant 2 dose series at 0 and 2-6 months Licensed October 2017 for adults 50 years old Source: GSK 14

15 Soapbark Tree Source: Source: Romulo Colindres, GSK, ACIP Presentation Oct 19, 2016 ACIP Recommendation October 2017* Herpes zoster subunit vaccine (Shingrix ) is recommended for: 1. Prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older 2. Prevention of HZ and related complications for immunocompetent adults who previously received zoster vaccine live (Zostavax ) Adjuvanted recombinant vaccine (Shingrix ) is preferred over live zoster vaccine (Zostavax ) for the prevention of herpes zoster and related complications * Pending acceptance by CDC Director and publication in MMWR 15

16 Scientific Basis for Recommendations Vaccine efficacy against zoster and PHN Safety and reactogenicity Cost-effectiveness and impact on health outcomes Formal GRADE analysis to assess quality of evidence for each vaccine Pivotal Phase 3 Clinical Trials Study Population Status ZOE-50 Adults 50 years Complete ZOE-70 Adults 70 years Complete 16

17 ZOE-50 ZOE-70 17

18 RESULTS: High Efficacy in All Age Groups Over 4 Years GROUP EFFICACY (%) 95% CI ZOE-50 Age Pooled ZOE- 50/70 Age Age Age Age Age Year Year Year Year PHN Age Cunningham AL and Heineman T. Exp Rev Vac 2017 Jul;16(7):

19 CD4 Response and ge Antibodies Decline Gradually but Remain Above Pre-Vaccination Level for 6 Years ge-specific cell-mediated response after 2 doses Anti-gE antibody concentration Prevaccination level Pre-vaccination level Figures 2 and 3 Chlibek R et al. Vaccine 2016 Feb 3;34(6):

20 Shingrix Safety Profile Injection Site Reactions and Systemic Symptoms Were Common 80% Shingrix Placebo 60% 40% 20% 0% Any AE Pain Swelling Myalgia Grade 3 Reaction Most symptoms resolved within 2-4 days Lal H. NEJM

21 No Increased Risk of Serious Adverse Events 10% 8% HZ/su Placebo 6% 4% 2% 0% Any serious AE Potential immune disease Death Lal H. NEJM 2015 Assessment of Potential Immune- Mediated Diseases Category Examples Neuroinflammatory Musculoskeletal Skin Liver GI MS, Guillan-Barre, narcolepsy Lupus, scleroderma, rheumatoid arthritis Psoriasis, vitiligo, Raynaud s Primary biliary cirrhosis, autoimmune hepatitis Crohn s disease, ulcerative colitis Metabolic Autoimmune thyroiditis, diabetes type 1 Vasculitides Others Temporal arteritis, polyarteritis nodosa Sarcoidosis, pulmonary fibrosis, glomerulonephritis Lal H et al. NEJM

22 Similar Distribution of Potential Immune Mediated Diseases in Vaccine and Placebo Group Table S4. Lal H. NEJM 2015 Post-Licensure Safety Monitoring Near-real time assessment of pre-specified adverse events in CDC Vaccine Safety Datalink Manufacturer safety study Vaccine Adverse Events Reporting System (VAERS) 22

23 Co-administration with Influenza Vaccine RCT compared co-administration (IIV + dose 1 Shingrix ) and sequential administration (2 month separation between IIV and Shingrix dose 1) Co-admin Control 828 volunteers age 50+ randomized Anti-gE seroresponse was 96% in coadmin group vs 98% in controls after dose Influenza post-vaccination GMTs and mean fold rise were similar across groups anti-ge geometric mean concentration after dose 2 Shingrix Immune Response and Safety in Prior Zostavax Recipients Open label trial in adults 65 years Matched on prior Zostavax receipt ( 5 years) or no prior Zostavax Outcomes: immune response, safety, reactogenicity 430 participants Immune response, safety and reactogenicity similar between groups Anti-gE antibody ge specific CD4+ T cells Figure 3. Grupping K et al. JID 2017 (prepub) 23

24 Shingrix Cost-Effectiveness AGE GROUP Cost per QALY Saved* years $46, years $25, years $11, years $9, years $27,310 ALL 50+ years $30,797 *Societal perspective Source: Lisa Prosser, ACIP Presentation October 25, 2017 Health Outcomes Comparing No Vaccine, ZVL, & HZ/su Assumptions: -Cohort 1 million vaccines (60-69 year olds) -Health outcomes measured over the lifespan -HZ/su recipients completed 2 doses VE HZ/su wanes to 0% over ~19 yrs -ZVL wanes to 0% over ~10 yrs Cases Expected Cases Averted HZ/su vs. ZVL Outcome No Vaccine ZVL HZ/su (ZVL- HZ/su) HZ cases 204, , ,000 53,000 PHN cases 31,000 25,000 21,000 4,000 Source: Kathleen Dooling, ACIP Presentation October

25 Summary of Evidence Regarding Shingrix High level of protection without meaningful waning over 4 years High efficacy in older adults at greatest risk for zoster complications Highly reactogenic with injection site reactions and systemic symptoms that interfere with daily activities in ~15% No association with serious adverse events, including potential immune-mediated diseases Cost-effectiveness is favorable and superior to Zostavax under a wide range of assumptions Caveats and Questions No real world data on vaccine effectiveness and safety New adjuvant Reactogenicity and series completion rate Efficacy of 1 dose unknown Lacking robust efficacy data for some racial groups Co-administration with adjuvanted flu vaccine and other adult vaccines Efficacy/safety of adjuvanted or inactivated zoster vaccines in immunocompromised adults (trials in progress) 25

26 Practice-Based Strategies New Standards for Adult Vaccination ASSESS vaccination status of all patients in every clinical encounter Strongly RECOMMEND vaccines that patients need ADMINISTER needed vaccines or REFER to a provider who can vaccinate DOCUMENT vaccines received by your patients Centers for Disease Control and Prevention. Standards for adult immunization practice: Overview. cdc.gov/vaccines/hcp/patient-ed/adults/for-practice/standards/index.html. 26

27 Zoster Vaccine Storage Zostavax (Live, attenuated HZV) Must be kept frozen -15 to -50 May be refrigerated 2 to 8 for up to 72 hours prior to reconstitution Reconstitute with MFG supplied diluent (store diluent at room temperature) Must be used within 30 minutes Protect vials from light Shingrix (HZ/su) Must be refrigerated 2 to 8 Do NOT freeze (discard if frozen) Mix antigen component vial adjuvant suspension vial Use immediately or may refrigerate for up to 6 hours Protect vials from light Standing Orders Standing orders authorize nurses, pharmacists, and other healthcare personnel where allowed by state law, to assess a client's immunization status and administer vaccinations according to a protocol approved by an institution, physician, or other authorized provider. The protocol enables assessment and vaccination without the need for examination or direct order from the attending provider at the time of the interaction. 27

28 Vaccine Administration Zostavax (Live, attenuated HZV) Subcutaneous administration Shingrix (HZ/su) Intramuscular administration in the deltoid Shoulder Injury Related to Vaccine Administration (SIRVA) SIRVA is thought to result from the unintentional injection of a vaccine into tissues and structures lying underneath the deltoid muscle of the shoulder The Institute of Medicine (IOM) reviewed the scientific and medical literature finding that the evidence convincingly supported a causal relationship between vaccine administration and deltoid bursitis Atanasoff et al. published a case series reporting the experience of the Vaccine Injury Compensation Program with regard to shoulder injuries following vaccination. The IOM reviewed this article and commented that the cases were consistent with deltoid bursitis. 28

29 Preventing SIRVA Follow CDC guidance for appropriate needle length selection 1 Ensure proper administration technique for intramuscular injections Central portion of deltoid Avoid the top 1/3 of the deltoid 2 Comprehensive, skills-based training should be integrated into existing staff education programs such as new staff orientation and annual education requirements 1 Persons administering vaccine should be in the same seated position as the patient. Avoid standing to administer vaccine to a patient who is seated ACIP General Practice Recommendations ACIP October 2017 Presentation of Dr. Andrew Kroger, CDC 29

30 Recommending Vaccine Make a firm, positive vaccine recommendation: Our records don t show that you ve received a shingles vaccine. We need to take care of that for you today while you are here. vs. Would you like to get your shingles vaccine while you are here? What If The Patient Refuses Or If There Is Payment Issue? Patient refusal of vaccination should always be considered TEMPORARY unless there is a contraindication This means ASSESS at every visit! When a patient refuses, take time to find out the true objection. Often patients refuse because they have unanswered questions! REFER to another provider Example: Hospitals should include vaccines with discharge orders, as part of care transitions, and electronic prescriptions Example: Outpatient primary care providers can issue prescriptions for vaccines (even those refused for non-legitimate reasons) Example: Pharmacists should refer patients to primary care when prescription insurance does not cover the vaccine 30

31 NFID Shingles Awareness Toolkit Recalling Patients for Vaccines Dosed in a Series Give the patient an appointment card/tangible reminder with a specific date to return to clinic for 2 nd dose before they leave the office/pharmacy Use recall reminders (e.g., telephone, text, ) one or more days prior to the date to return Assess dose completion of series-dosed vaccines at each patient encounter Offer vaccines in the late afternoon, evening, and on weekends Partner with other providers to complete series (e.g., family medicine office administers dose 1; pharmacist administers dose 2) Designate an immunization champion within your practice Adapted from CDC. 31

32 Documentation: Critical Registries are NOT just for childhood vaccines! Questions & Answers 32

33 CME/CNE Credit & Webinar Evaluation The National Foundation for Infectious Diseases (NFID) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians. NFID designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit TM. This continuing nursing education activity was approved by the Ohio Nurses Association, an accredited approver by the American Nurses Credentialing Center s Commission on Accreditation (OBN ). This education activity has been approved for a maximum of 1.o contact hour. To receive credit or contact hours, you must complete the online evaluation and pass the post-test with a score of 80% or higher Online evaluation and post-test will be available following the webinar at: Certificate will be available for print or download following successful completion of online evaluation and post-test until December 6, 2018 Stay Informed About Upcoming Webinars NFID Webinar Library: Subscribe to NFID updates: 33