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1 Updates from June 2017 ACIP Meeting Thursday, July 13, :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 play 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 Updates from June 2017 ACIP Meeting William Schaffner, MD, NFID Medical Director Amanda C. Cohn, MD, MPH Executive Secretary, Advisory Committee on Immunization Practices (ACIP) CDR, US Public Health Service Centers for Disease Control and Prevention 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, 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 July 13, CPE Credit & Webinar Evaluation The National Association of Chain Drug Stores (NACDS) is accredited by the Accreditation Council for Pharmacy Education to provide continuing pharmacy education (CPE) for pharmacists. NACDS designates this enduring material for a maximum of 1.0 contact hour of CPE credit. To receive contact hour, 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: webinars/acip-recommendations

4 Disclosures Marla Dalton (NFID staff, content reviewer) owns stock, stock options, or bonds from Merck & Co., Inc. William Schaffner (NFID medical director, presenter) served as an advisor or consultant for Dynavax, GSK, Merck & Co., Inc., Novavax, Inc., Pfizer Inc., Sanofi Pasteur, and Seqirus All other activity planners/reviewers and staff for this activity have no relevant financial relationships to disclose Learning Objectives At the conclusion of this webinar, participants will be able to: Describe current ACIP recommendations for adult and childhood/adolescent immunization Explain how recent changes to vaccine recommendations will impact vaccination programs Discuss information on new and/or future vaccines for potential use in practice 4

5 About NFID Non-profit 501(c)(3) organization dedicated to educating the public and healthcare professionals about causes, treatment, and prevention 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 Updates from June 2017 ACIP Meeting Wednesday, October 5, :00 PM ET William Schaffner, MD NFID Medical Director Professor of Preventive Medicine and Infectious Diseases Vanderbilt University School of Medicine 5

6 Influenza Vaccine Influenza Season Vaccine Effectiveness Recommendations 6

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8 Summary of Influenza Season Prolonged (17 week vs 13 week average) Moderate severity consistent with A (H3N2) 99 pediatric deaths National peak mid-february Western states earlier; peak late December January No safety signals Vaccine Effectiveness Summary Vaccine reduced outpatient flu visits by 42% overall 34% A (H3N2) Vaccine reduced flu hospitalizations by 30% all adults 37% 65 Systems cannot assess effectiveness by specific flu vaccine type 8

9 Influenza Vaccine Recommendations Basically, the same (VOTE) Everyone older than 6 months Recombinant (Flublok ) may be used in pregnancy Afluria 5 years LAIV (FluMist ) not recommended Hepatitis A Update 2006 recommendations 9

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11 Hepatitis A Epidemiology Cases, deaths, and hospitalizations at alltime low Disease rates highest in middle-age adults Hepatitis A Risk Factors International travel Food/water outbreak Child/employee daycare Sexual/household contact with Hep A patient MSM Injection drugs 11

12 Hepatitis A Vaccination Routine vaccination at 12 through 23 months Lowest of routine vaccinations month children: 1 dose 26% 2 doses 60% Adolescents: 1 dose 63% 2 doses 57% Daycare/school mandates: 21 states Hepatitis A Vaccine Discussion Strengthen language recommending catch-up vaccination of children/adolescents, age 2-18 years Align language defining chronic liver disease with the hepatitis B recommendations 12

13 Herpes Zoster (HZ) and Post Herpetic Neuralgia (PHN) Epidemiology, United States Annual rate ~4 HZ cases per 1,000 population (1 million cases annually) 1,2 Incidence increases with age, ranging from <1 case/1,000 children to >15 cases/1,000 population 80 years and older 2,3 For adults 50 years and older with HZ, 10-18% will go on to develop PHN; similar to HZ, incidence increases with age 3 1. Jumaan et al., JID, 2005, 191: Yawn, et al., Mayo Clin Proc. 2007; 82: Insinga et al., J Gen Intern Med. 2005, 20: Zoster Vaccine(s) Merck Zostavax (ZVL) Attenuated Live chickenpox (x14) 1 dose GSK Shingrix TM (HZ/su) Glycoprotein E + adjuvant 2 doses, a month apart More local reactions Adults 60 Efficacy vs shingles 51% Efficacy vs PHN 65% Protection wanes over 7-10 yrs Adults 50 Efficacy vs shingles 92% Protection maintained over 4 yrs 13

14 HZ Vaccine Uptake (%), Adults 60 7/14/2017 Vaccination Coverage of Herpes Zoster Vaccine Live, Among Adults 60 Years, United States, * 2007: National immunization Survey (Lu et al, Vaccine 27:882-7); : NHIS (Am J Prev Med 40:e1-6 & MMWR February 5, 2016 / 65(1);1 36) Vaccine Efficacy Against HZ for ZVL and HZ/su, by Year Following Vaccination ZVL HZ/su (SPS+STPS+LTPS) (ZOE 70) Note: The Shingles Prevention Study, Short-term Persistence Study, and Long-term Persistence Study followed the same study population in a randomized control trial over time 28 14

15 Zoster Vaccine Presentations HZ/su in persons previously given ZVL ( 5 years) -Similar immunogenicity, safety, and reactogenicity Two cost-effectiveness models Herpes Zoster Vaccine Policy Questions Should ACIP recommend HZ/su immunocompetent adults? (Category A or B?) At what age should HZ/su recommendation start? Should ACIP recommend a preference for HZ/su over ZVL? Should ACIP recommend persons previously vaccinated with ZVL receive HZ/su? 15

16 Updates from June 2017 ACIP Meeting Wednesday, October 5, :00 PM ET Amanda C. Cohn, MD, MPH Executive Secretary, Advisory Committee on Immunization Practices CDR, US Public Health Service Centers for Disease Control and Prevention Atlanta, GA ACIP WG Preparing for Potential Submission of BLA for Dengue Vaccine DenVaxia (Sanofi Pasteur): Clinical studies in persons living in endemic areas Would not be a vaccine for travelers to endemic areas Vector present endemic dengue Caribbean: Puerto Rico, Virgin Islands Pacific Islands Vector present non-endemic potential for transmission Outbreaks in: Texas (US - Mexico border), Florida, Hawaii Many states (e.g., FL, GA, AL, LA, MI, SC, NC, TX, AZ, CA) Vector not present 16

17 Dengue Transmission in US Non-Endemic Areas South Texas with repeated small dengue outbreaks and local transmission since the 1980 s Seroprevalence data > 10 years old suggests border crossing subpopulation with significant past exposure to dengue Other US Mexico border states at risk for dengue but no evidence of local transmission to date South Florida - repeated small dengue outbreaks since 2009 Hawaii has had two outbreaks and a small cluster of cases since 2001 Primarily Aedes albopictus transmitted ACIP Recommendations for Use of Yellow Fever (YF) Vaccine in Travelers Recommended for persons aged 9 months who are traveling to or living in areas at risk for YF virus transmission Because of rare but serious adverse events (SAE), healthcare professionals should vaccinate only persons at risk for exposure to YF virus or who require proof of vaccination for entry To minimize risk for SAE, healthcare professionals should observe contraindications and consider precautions to vaccination before administering vaccine 17

18 YF-VAX Supply Update To improve supply of yellow fever vaccine in the US, Sanofi Pasteur is transitioning manufacturing of YF-VAX to a new state-of-the-art facility by mid-2018 Manufacturing issues resulted in a gap in YF-VAX vaccine supply from the time of the shutdown of the old facility to operation of the new facility Ordering restrictions have stretched the remaining supply of YF-VAX vaccine and 2 lots that were being investigated for deviations are in undergoing clearance for shipping We expect to exhaust our supply of YF-VAX in early July Importation of Stamaril Vaccine Sanofi Pasteur worked closely with the FDA to import Stamaril vaccine under IND and distribute it in the US in an Expanded Access Program (EAP) EAP protocol allows product to be used at authorized facilities in a restricted format Beginning May 23, 2017, Sanofi Pasteur began supplying Stamaril vaccine to certified clinics to maintain supply of yellow fever vaccine in the US Currently in process of onboarding 250 clinics across US 18

19 Difference Between Current ACIP Recommendations and EAP Protocol Criteria Asymptomatic HIV infection with no evidence of immune suppression* Vaccine recommended for at risk travelers in ACIP recommendations Precaution in EAP protocol Age 6-8 months Precaution in ACIP recommendations Exclusion criteria for EAP protocol Breastfeeding Precaution in ACIP recommendations Exclusion criteria for EAP protocol unless can discontinue for 14 days *No immune suppression is defined as CD4+ counts 500/mm 3 or 25% of total lymphocytes for children <6 years Mumps Work Group: Terms of Reference Objective Evaluate and propose policy options to prevent or control mumps outbreaks in the United States Activities Review epidemiology of mumps in the 2-dose vaccine era, including the international experience Review available evidence on duration of immunity for mumps after 2 doses of MMR and other risk factors for vaccine failure Review available evidence on impact of a 3 rd dose of MMR for mumps outbreak control Evaluate programmatic implications and cost of various policy options for a 3 rd dose of MMR to prevent or control mumps outbreaks 19

20 Reported Mumps Cases 7/14/2017 Reported Mumps Cases, United States, Vaccine Era, st Dose ACIP Recommendati on nd Dose MMR ACIP Recommendati on First National Outbreak Source: National Notifiable Diseases Surveillance System (passive surveillance); 2016 data is preliminary (May 31, 2017) and subject to change Mumps Cases, Incidence Rate (IR) and Outbreak (OB)-Related Data, United States, Case Count IR OB Cases % of OB Cases Jurisdi ctions w/ob cases Source: National Notifiable Disease Surveillance System (passive surveillance); 2016 and 2017 data is preliminary (as of May 31, 2017) and subject to change; data provided by Nakia Clemmons (CDC) 20

21 Characteristics of Reported Mumps Cases and Outbreaks, United States, 2017* Highest incidence: age group Age: median=23 years, IQR=15-30 years Vaccination status: 73% 2 MMR doses Outbreaks: at least 40 known to CDC 19 universities 14 community-wide (9 in close-knit communities; 8 in Marshallese communities) 7 other close contact settings: prison [3], high school [2], military facility [1], hockey team [1] Reported Mumps Incidence Rates by Year and Age Group, United States, Source: National Notifiable Disease Surveillance System (passive surveillance); 2016 and 2017 data is preliminary (as of May 31, 2017) and subject to change; data provided by Nakia Clemmons (CDC) 3 rd Dose Mumps Vaccine Effectiveness Study: Background 2015: Johnson County, Iowa reported >300 cases University of Iowa: 2-dose MMR requirement since 2012, doses verified by staff 2 doses required to register for next semester s courses Implemented large 3 rd dose campaign in university 21

22 Incremental VE of 3 Versus 2 Doses of Mumps Vaccine Immune response post vaccination 7 days 14 days 21 days 28 days Incremental VE (3v2) 60.2% 63.4% 68.4% 78.2% 95% CI P-value 38.6, , , , 87.8 < < < < Meningococcal Session February 2017 ACIP Discussed considerations for MenB booster doses for groups at increased risk for serogroup B meningococcal disease Concern about rapid decline in the immune correlate of protection (SBA) by 12 months Cases of serogroup B meningococcal disease after vaccination have not been reported in persons at increased risk, except for patients receiving Eculizumab Additional data on antibody persistence and booster response needed MenB = serogroup B meningococcal vaccine; SBA = serum bactericidal activity 44 22

23 Eculizumab (Soliris, Alexion Pharmaceuticals) Complement component inhibitor licensed in the US for treatment of two rare, life-threatening illnesses: Paroxysmal nocturnal hemoglobinuria (PNH) (2007) Lifelong eculizumab treatment expected Atypical hemolytic uremic syndrome (ahus) (2011) Optimal treatment duration not clear may be lifelong for some patients but shorter for others 1 Both have annual incidence of ~ /100,000 2,3 FDA-approved prescribing information includes a Black Box Warning for increased risk of meningococcal disease in recipients 1 Zuber et al. 2012, Nat Rev Nephrol 8(11): UK: Hill et al. 2006: 3 Region not specified: Noris and Remuzzi: 45 Soliris Risk Evaluation and Mitigation Strategy (REMS) Patient Medication Guide Patient Safety Information Card Prescriber certification providers agree to: Counsel patients and provide the patient educational materials Provide the Medication Guide to patients prior to each infusion Review the educational materials and product labeling and comply with directions for safe use Ensure patients receive a meningococcal vaccine Promptly report meningococcal disease cases to FDA or Alexion Assessments submitted to FDA every two years 46 23

24 Case Report Summary Fatal meningococcal disease case in adolescent treated with eculizumab Patient vaccinated with MenACWY and MenB vaccines ~6 months before disease onset Strain NG by SASG, PCR, and WGS MenB-4C expected to provide protection against this strain based on antigen typing Serum from 6 healthy adults (pre- or post-vaccination) easily killed this strain Patient died despite apparently strong memory antibody response to strain Normally nonpathogenic strain led to fatal illness despite vaccination 47 Epi-X: Call for Cases of Meningococcal Disease in Persons Taking Eculizumab, 2007-Present 16 cases identified: At least 8 of 16 cases (50%) due to NG strains 5 NG by PCR 3 more NG by SASG with capsule operon defect identified by WGS 40% of cases with known MenACWY vaccination status and 57% of cases with known MenB vaccination status ( ) had not been vaccinated prior to disease onset Routine case investigations may not capture full vaccination history 2/4 (50%) of serogroup Y (SASG) cases occurred in persons with prior MenACWY vaccination Vaccination provides incomplete protection to eculizumab recipients 48 24

25 Summary Eculizumab associated with 1,000 2,000x increased incidence of meningococcal disease Numerous meningococcal disease cases in eculizumab recipients due to nongroupable N. meningitidis Usually commensals that rarely cause disease No protection from MenACWY; protection with MenB vaccines unknown Breakthrough cases in spite of vaccination for appropriate serogroup (MenACWY 1,2 or MenB 3,4 ) In vitro eculizumab blocks whole blood killing Opsonophagocytosis blocked or inadequate for meningococcal killing 1 ementadvisorycommittee/ucm pdf 2 Cullinan et al. 2015; Pediatrics 135(6):e Real et al Enferm Infecc Microbiol Clin 35(3): Parikh et al. IPNC 2016 abstract, available at: 49 Role for Antibiotic Chemoprophylaxis? Some countries recommend antibiotic prophylaxis for duration of eculizumab treatment UK: Patients are advised to take daily prophylactic antibiotics, either penicillin or erythromycin 1 France: Continuous antibiotic chemoprophylaxis recommended until 60 days after stopping eculizumab treatment 2 Some individual providers choose to recommend for some or all patients No official guidance in US CDC reported these cases in an MMWR report July Zuber et al Nat Rev Nephrol 8(11):643-57,

26 Vaccine Adverse Event Reporting System (VAERS) 2.0 VAERS 2.0 consists of two major initiatives A new VAERS form with revised data elements VAERS 2.0 reporting form An updated processes for submitting VAERS reports Option 1: updated online reporting tool Option 2: writable PDF form combined with electronic document upload capability 51 Partial Screen Shot of VAERS 2.0 Online Reporting Tool (Direct Online Reporting) VAERS 2.0 Form (Writable, Savable, and Uploadable to VAERS Website) Essential items (high value data elements) are highlighted with asterisks in the online reporting tool and with yellow boxes in the writable PDF form 26

27 Questions & Answers Register at: New for Fall 2017: Call for Poster Abstracts (9/6/17 Submission Deadline) 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 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 July 13,

28 CPE Credit & Webinar Evaluation Visit: Select course Advisory Committee on Immunization Practices (ACIP) Recommendations, 2017 Live under Claiming Credit Select Add to Cart Login or sign-up for a LearnSomething account Select View Enrollment and course title under Activities Enter Attendance Code, complete Post-Test and Evaluation, and enter NABP number and birthdate to claim credit Contact education@nacds.org with any questions ATTENDANCE CODE: 3TGXWK Join Us For Upcoming NFID Webinars Maternal Immunizations Thursday, August 10, 2017 at 12:00 PM ET Registration: Subscribe to NFID updates: 28