In Case of Technical Difficulties

Transcription

1 Updates from February 2018 ACIP Meeting Wednesday, March 7, :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 February 2018 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 of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation (OBN ), 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: bit.ly/acipwebinar-0307 Certificate will be available for print or download following successful completion of online evaluation and post-test until March 7, CPE Credit & Webinar Evaluation The National Association of Chain Drug Stores (NACDS) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). NACDS designates this enduring material as 1.0 contact hour of ACPE accredited continuing education. Updates from February 2018 ACIP Meeting (ACPE Universal Activity # L06-P. Initial Release Date: 03/07/2018). To receive contact hour credit, 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: nacds.learnercommunity.com/home 3

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

5 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) About NFID Scientific meetings, research, and training Longstanding partnerships to facilitate rapid program initiation and increase programming impact Flexible and nimble organization Updates from February 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 Nashville, TN 5

6 HEPATITIS B VACCINE HEPLISAV-B (Dynavax) Hepatitis B An infection of the liver caused by hepatitis B virus (HBV) Transmitted through percutaneous or mucosal exposure to blood or body fluid Viable on environmental surfaces for at least 7 days Transmitted in the absence of visible blood Symptoms include anorexia, malaise, abdominal pain, nausea, vomiting, and jaundice Extra-hepatic manifestations (e.g., skin rashes, arthralgias) may occur Bond et al., Lancet 1981;317: Trepo et al., Lancet 2014;384:

7 Acute and Fulminant Hepatitis B Acute infection symptomatic in 30-50% of adults Fatality rate <1.5%; higher in adults 55 years Fulminant infection uncommon (<1%) Often results in death or liver failure necessitating transplantation Surveillance for Viral Hepatitis United States, 2015 ( McMahon et al., JID 1985;151: Trepo et al., Lancet 2014;384: Chronic Hepatitis B Chronic infection develops in: 90% of persons infected during infancy <1-12% of persons infected during adulthood More frequent among immunosuppressed, persons with diabetes Persons with chronic hepatitis B have 15-25% risk for premature death from cirrhosis or liver cancer 850, million persons estimated to be living with HBV infection in the US Hyams, CID 1995;20: Surveillance for Viral Hepatitis United States, 2015 ( Roberts et al., Hepatol 2016;63: Wasley et al., JID 2010;202: Kowdley et al., Hepatol 2012;56:

8 Reported cases/100,000 population Number of cases 3/7/2018 Reported Number of Acute Hepatitis B Cases United States, ,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Increase associated with concomitant rise in injection-drug use Year National Notifiable Diseases Reporting System Surveillance for Viral Hepatitis United States, 2015 ( Incidence of Acute Hepatitis B by Age Group United States, yrs yrs yrs yrs yrs 60+ yrs Year National Notifiable Diseases Reporting System Surveillance for Viral Hepatitis United States, 2015 ( 8

9 Hepatitis B Vaccines Vaccine available in US since 1981 (plasma) Recombinant vaccine available since 1986 Safe, immunogenic, effective Anaphylaxis in yeast-sensitive individuals: 1.1 per million doses administered (95% CI, ) Generally administered as a 3-dose series* Protection lasts 30 years Booster doses not routinely recommended *Recombivax licensed for 2-dose schedule for adolescents aged years; 4-dose series available (e.g., when using combination vaccine, compressed schedule for travel, dialysis) Stratton et al., National Academies Press 2012; Bohlke et al., Pediatr 2003;112: Bruce et al., JID 2016;214: Schillie et al., MMWR 2018;67:1-31. Currently-Recommended Hepatitis B Vaccines Monovalent formulations (all ages) Engerix Recombivax Combination formulations Pediarix (6 weeks through 6 years) Hepatitis B, diphtheria, tetanus, pertussis, polio Twinrix ( 18 years) Hepatitis A, hepatitis B Schillie et al., MMWR 2018;67:

10 Persons Recommended for Hepatitis B Vaccination All infants and children aged <19 years Persons at risk for infection by sexual exposure sex partners of HBV-infected persons, persons with multiple sex partners, men who have sex with men Persons at risk for infection by percutaneous or mucosal exposure to blood injection-drug users, household contacts of HBV-infected persons, healthcare and public safety workers, persons with end-stage renal disease and dialysis patients, adults with diabetes Others international travelers to regions with high or intermediate HBV endemicity, persons with Hepatitis C Virus (HCV) and chronic liver disease, persons with HIV infection, incarcerated persons All persons seeking protection from HBV infection Schillie et al., MMWR 2018;67: Assessment of Serologic Evidence of Protection Antibody to hepatitis B surface antigen (anti-hbs) 10mIU/mL measured 1-2 months after vaccine series completion corresponds to vaccine-induced protection Anti-HBs 10 miu/ml in healthy adults aged <40 years: After 1 dose: 30-55% After 2 doses: 75% After 3 doses: 90% Lower 3-dose seroprotection associated with advanced age, diabetes, renal disease/dialysis, obesity, chronic illness, smoking Diabetes: % Dialysis: % Sit et al., World J Hepatol 2015;7: Asan et al., Int Urol Nephrol 2017;49: Leuridan et al., CID 2011;53: Jack et al., JID 1999;179: Schillie et. al., Diab Care 2012;35:

11 HEPLISAV-B FDA licensed November 9, 2017 Indicated for active immunization against infection caused by all known subtypes of HBV in persons aged 18 years Series of 2 doses, separated by 1 month Uses 1018 adjuvant (immunostimulatory cytidine-phosphateguanosine [CpG] motifs), which binds Toll-like receptor 9 to stimulate directed immune response to hepatitis B surface antigen (HBsAg) Immunogenicity Studies demonstrate high rates of seroprotection: % of subjects receiving HEPLISAV-B TM vs % of subjects in the comparison group Type 2 diabetes mellitus: 90.0% (HEPLISAV-B TM ) vs. 65.1% (comparator) Chronic kidney disease: 89.9% (HEPLISAV-B TM, 3 doses) vs. 81.1% (comparator, 4 double doses) Halperin et al., Vaccine 2006;24: Halperin et al., Vaccine 2012;30: Heyward et al., Vaccine 2013; 31: Jackson et al., Vaccine 2018;36: Janssen et al. Vaccine 2013;31: HEPLISAV-B TM package insert 11/

12 Safety and Reactogenicity Mild and serious adverse events similar* Mild: 45.6% (HEPLISAV-B) vs. 45.7% (comparator) Serious: 5.4% (HEPLISAV-B) vs. 6.3% (comparator) Cardiovascular events: 0.27% (HEPLISAV-B ) vs. 0.14% (comparator) Potentially immune-mediated adverse events** % (HEPLISAV-B ) vs % (comparator) Safety to be further assessed through post-marketing studies *Herpes zoster: 0.68% (HEPLISAV-B) vs. 0.32% (comparator) (RR=2.1, 95% CI= ) **e.g., granulomatosis with polyangiitis, Tolosa-Hunt Syndrome, autoimmune thyroiditis, vitiligo Halperin et al., Vaccine 2006;24: Halperin et al., Vaccine 2012;30: Heyward et al., Vaccine 2013; 31: Jackson et al., Vaccine 2018;36: Janssen et al. Vaccine 2013;31: HEPLISAV-B package insert 11/2017 US FDA, HEPLISAV-B ( Work Group Summary HEPLISAV-B likely to improve hepatitis B vaccine series completion and result in earlier protection (2 doses over 1 month) Especially beneficial in persons with anticipated low adherence (e.g., injection drug users) Improved immunogenicity in populations with typically poor vaccine response e.g., elderly, diabetes, dialysis Post-marketing surveillance studies and additional data, including safety, pertaining to the use of HEPLISAV-B will be reviewed by ACIP as they become available, and recommendations will be updated as needed Prior to preferential consideration Future economic analyses may inform cost-effectiveness considerations of HEPLISAV-B, including its use among persons at an increased risk for vaccine non-response 12

13 ACIP VOTE HEPLISAV-B is a hepatitis B vaccine that may be used to vaccinate adults age 18 years and older against infection caused by all known subtypes of HBV Hepatitis A ACIP voted unanimously to pass the following recommendations pertaining to Hepatitis A: Hepatitis A vaccines should be administered for post-exposure prophylaxis for all persons age 12 months or older Hepatitis A vaccine or immune globulin (IG) may be administered to persons age 40 years or older, depending on the providers risk assessment Hepatitis A vaccine should be administered to infants age 6-11 months traveling outside the US when protection against hepatitis A is recommended 13

14 PNEUMOCOCCAL VACCINES BACKGROUND Pneumococcal conjugate vaccine is used routinely in childhood immunization (PCV13) As a consequence, invasive pneumococcal disease due to the 13 serotypes in the vaccine has been profoundly reduced in children PCV13 also substantially reduces pneumococcal carriage in children thus they do not transmit these to adults 14

15 BACKGROUND (continued) Pneumococcal conjugate vaccines have dramatically reduced invasive pneumococcal disease (IPD) in adults through indirect effects ACIP recommended routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults aged 65 years in 2014 PCV13 effective against IPD including pneumonia with bacteremia PCV13 demonstrated 45% efficacy against vaccine-type non-bacteremic pneumococcal pneumonia ACIP QUESTION In 2014, ACIP said that in 2018 would evaluate the benefits expected from continued use of PCV13 in adults 65 years old 15

16 Pneumococcal Pneumonia as Cause of Community Acquired Pneumonia (CAP) S. pneumoniae is a common cause of CAP Estimated to cause 27% of CAP pre-pcv13 CAP incidence attributable to S. pneumoniae is difficult to estimate Blood culture has low sensitivity Detects 25% of pneumococcal pneumonia cases Pneumococcal urinary antigen test (UAT) Sensitivity 74 75% and specificity 95 97% Not universally available or routinely used by all healthcare professionals Evidence Presented to Date PCV13 coverage among adults 65 years old around 40% Lower among year olds, varies by indication Pneumococcal carriage among adults 65 years old Very low pneumococcal carriage (1.8%) PCV13-type carriage 0.2% in Invasive pneumococcal disease (IPD) PCV13-type IPD declined among all age groups IPD incidence in adults 65 years old plateaued in Modeled direct and indirect PCV13 effects on IPD in adults 65 years old project relatively few cases prevented directly 16

17 Upcoming ACIP Meetings Continued updates about PCV13 impact on pneumonia Model estimating public health impact and costeffectiveness of different policy options including: No PCV13 for adults 65 years old Expanding indications for adults <65 years old Updates from February 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 17

18 ACIP Updates Influenza, Evidence-Based Recommendations, HPV, Meningococcal Influenza Vaccines Updates 18

19 Agenda Overview Efficacy of Fluarix Quadrivalent in Children 6 through 35 Months of Age Dr. Leonard Friedland (GlaxoSmithKline) Surveillance Update Ms. Lynnette Brammer (CDC/NCIRD/Influenza Division) Vaccine Effectiveness Update Dr. Brendan Flannery (CDC/NCIRD/Influenza Division) Results of a Randomized Trial of a New H1N1 LAIV Strain in US Children Dr. Raburn Mallory (MedImmune/AstraZeneca) Review of LAIV Effectiveness for 2- Through 17-Year-Olds Dr. Lisa Grohskopf (CDC/NCIRD/Influenza Division) Considerations and Proposed Recommendations Dr. Lisa Grohskopf (CDC/NCIRD/Influenza Division) Problem: Influenza is an important cause of morbidity and mortality in children Pediatric deaths ranging from 37 ( ) to 171 ( ) each non-pandemic season since deaths during 2009 pandemic period Also important cause of hospitalizations data from FluView Interactive: Hospitalizations/100,000 persons-years Season 0-4 years 5-17 years

20 Benefits vs. Harms: Benefit of the current formulation of LAIV4 against H1N1pdm09- like viruses is currently not known (no effectiveness data yet) Data suggest good effectiveness of LAIV4 against influenza B viruses Data suggest LAIV4 is comparable to IIV against H3N2 No new safety concerns raised for LAIV4 at the time that the recommendation for its use was removed Potential for harm if new formulation of LAIV4 is not effective Values: How Does the Target Population View the Balance of the Benefits and Risks? Some communications (published/unpublished letters) have expressed concern that lack of recommendation for LAIV may be detrimental in some settings (e.g., school-based clinics) Maintaining consumer confidence in influenza vaccines is important in the setting of low VE estimates overall 20

21 Acceptability: Risk of Recommending LAIV Without Effectiveness Data against H1N1 with the New Strain Work Group Perspectives: A plausible root cause of reduced effectiveness against H1N1pdm09 identified Some expressed view other factors (interference) may have contributed Varying viewpoints regarding promise of the shedding study data Some viewed it as encouraging Others expressed concern about the size of the study and problems with using immunogenicity/shedding to gauge effectiveness of LAIV If issue not resolved, potentially more influenza cases Understanding that influenza VE varies by season for all vaccines, and that initial licensure of some newer vaccines (e.g., some recent quadrivalents) has been based upon immunogenicity data Risk similar to introduction of new influenza vaccine product Acceptability: Risk that if LAIV is Not Recommended in the US during , It May Not Return to Market Work Group Perspectives: It is valued to have multiple types of influenza vaccine available LAIV remains a licensed product Challenge of holding all manufacturers to the same standards for effectiveness of influenza vaccines Effectiveness of LAIV has been examined each season For most other individual influenza vaccines, recommendation is not based upon annual assessment of product-specific VE 21

22 Implementation: Has Influenza Vaccine Coverage Been Impacted By Not Recommending LAIV? National vaccination coverage remained stable during the influenza season Local variation likely, reports of reduced coverage in areas with strong school-based programs that relied on LAIV National coverage did not increase, and was 2% lower in the 5-12 year-old age group Vote For the season, immunization providers may choose to administer any licensed, age-appropriate influenza vaccine (including LAIV, IIV, RIV). LAIV4 is an option for influenza vaccination for persons for whom it is otherwise appropriate. 22

23 Evidence Based Recommendations ACIP and the GRADE Approach ACIP adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach in October 2010 Quality of evidence for benefits and harms Going from evidence to recommendations Quality of evidence for benefits and harms is only one factor in developing a recommendation Other key factors include balance of benefits and harms, values, and health economic data ACIP Charter states, shall include consideration of disease epidemiology and burden of disease, vaccine efficacy and effectiveness, vaccine safety, economic analyses and implementation issues 23

24 Proposed Evidence to Recommendations (EtR) Framework Criteria Statement of Problem Public health importance Burden of disease Benefits and Harms Balance of desirable and undesirable effects Certainty in evidence (evidence profiles) Values and Preferences of target population Acceptability to stakeholders Resource Use Health Economic Analyses Feasibility Implementation considerations Use of the ACIP Evidence to Recommendations (EtR) Framework This is a proposed update to the current ACIP evidence-based recommendation process consistent with expansion of GRADE methodology guidance Precise language subject to continued improvement Guidance will be updated as experience is gained Additional supporting documents being developed Previous recommendations will not be retroactively put into the EtR format but the framework will be used when recommendations are periodically updated Completed EtR frameworks will be published online 24

25 HPV Vaccines Updates HPV Vaccine Session, February 2018 ACIP Meeting Post-licensure 9-valent HPV vaccine safety data Vaccine Adverse Events Reporting System (VAERS) update Dr. Jorge Arana (CDC/NCEZID) Rapid cycle analysis, Vaccine Safety Datalink Dr. Jim Donahue (Marshfield Clinic) Harmonization of HPV vaccination age recommendations for females and males Background and considerations Dr. Markowitz (CDC/NCIRD) Trends in HPV-associated cancers Dr. Elizabeth Van Dyne (CDC/NCCDPHP) Epidemiology of HPV in males Dr. Anil Chaturvedi (NIH/NCI) 25

26 Current Age Recommendations for HPV Vaccination in the United States Routine (for females and males) Age 11 or 12 years Series can be started beginning at age 9 years Persons not previously vaccinated (catch-up) Females through age 26 years Males through age 21 years Males 22 through 26 years may be vaccinated Males 22 through 26 years with immunocompromising conditions (including HIV), who are transgender, and who have sex with men* MMWR 2014;63 (RR05) MMWR 2015;64 *including men who identify as gay or bisexual, or who intend to have sex with men Considerations for Harmonization of Upper Age Recommendations for Males and Females Would simplify immunization schedule Might facilitate reaching males, including high-risk males 26

27 Coverage, % 3/7/2018 Estimated >1 Dose HPV Vaccination Coverage among year-olds, years years years years years years Females Males Self-reported vaccination history from NHIS, National Health Interview Survey Williams W, et al. MMWR 2017; Hung MC, et al. Next Steps for Consideration of Harmonization of Age Recommendations for Females and Males Review burden of disease and HPV epidemiology in males (today) Summarize vaccine efficacy data in males Values and acceptability surveys regarding the age harmonization policy Primary care providers Association of Immunization Managers Updated cost effectiveness analysis Extending 9vHPV for males from age 21 to 26 years in context of a 9-valent HPV vaccination program, under current vaccination coverage and costs Synthesize using Evidence to Recommendations Framework Potential vote in

28 Meningococcal Updates Serogroup B Meningococcal Disease among College Students Data presented to ACIP in June 2015 demonstrated that the estimated incidence of serogroup B meningococcal disease among college students aged years was low (0.09 cases/100,000) and was similar to that of non-college students during Cases and incidence in college students were estimated using multiple sources 1, as no national-level data available CDC shared plans to improve surveillance and report updated findings to ACIP on the incidence of disease in college students once additional data became available 1 Proportion of cases among college students in Active Bacterial Core surveillance applied to the number of cases in the National Notifiable Diseases Surveillance System (NNDSS) 28

29 Summary Incidence of serogroup B meningococcal disease in college students is low; however, college students aged years are at increased risk compared to non-college students Incidence of serogroups C, W, and Y in this age group is lower and similar in college students and non-college students, likely in part due to the adolescent MenACWY program Serogroup B college outbreaks are an important factor, though the risk remains elevated among college students even when excluding outbreakassociated cases MenB Vaccination of College Students In addition to the data presented, the Work Group has continued to review data on MenB vaccines as it has become available (much of it previously shared with ACIP) To summarize the key considerations for use of MenB vaccines in college students, the Work Group discussed: Burden of disease and population at risk Challenges with mass vaccination during outbreak response Effectiveness and duration of protection of MenB vaccines Molecular features of serogroup B isolates and expected strain coverage by MenB vaccines Cost-effectiveness of MenB vaccines in college students Awareness and use of MenB vaccines under Category B recommendation 29

30 ACIP Meningococcal Vaccines Work Group Interpretation Although the risk of serogroup B meningococcal disease is increased among college students, the number of preventable cases is low and number needed to vaccinate to prevent a case is high Limited duration of protection of MenB vaccines and the lack of evidence for impact on carriage may limit the ability to protect college students through the period of greatest risk MenB vaccination should occur as close to college entry as possible While achieving high MenB coverage during college outbreaks has been challenging, routine vaccination of all college students would also be difficult Awareness and uptake of MenB vaccines is currently low ACIP Meningococcal Vaccines Work Group Conclusion The Work Group does not propose any changes to the current MenB vaccine recommendations CDC could provide more guidance around clinical decision-making during precollege health visits 30

31 Questions & Answers 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 of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation (OBN ), 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: bit.ly/acipwebinar-0307 Certificate will be available for print or download following successful completion of online evaluation and post-test until March 7,

32 CPE Credit & Webinar Evaluation Visit: nacds.learnercommunity.com/home 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: H367WFD Join Us For Upcoming NFID Webinars HPV Vaccination: Recommendations and Strategies for Improving Coverage March 21, 2018 at 12:00 PM ET Registration: Subscribe to NFID updates: 32