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The Importance of Pneumococcal Vaccination Wednesday, February 3, 2016 12:00 PM ET In Case of Technical

audio only (either computer speakers or telephone connection) If the audio is choppy: Press pause in the top

1 The Importance of Pneumococcal Vaccination Wednesday, February 3, :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 You may call at any time for live assistance 2 1

2 Agenda Agenda Welcome and Introduction William Schaffner, MD, NFID Medical Director The Importance of Pneumococcal Vaccines Cynthia G. Whitney, MD, MPH, Chief, Respiratory Diseases Branch, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention Questions and Answers 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 2

3 CME 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. 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 Disclosures Marla Dalton (NFID staff, content reviewer) owns stock, stock options, or bonds from Merck & Co., Inc. William Schaffner (NFID medical director, content reviewer) served as an advisor or consultant for Merck & Co., Inc. Novavax, and Pfizer Inc.; and served as a speaker or member of a speaker s bureau for Merck & Co., Inc. All other faculty, activity planners/reviewers, and staff for this activity have no relevant financial relationships to disclose 3

Learning Objectives At the conclusion of this webinar, participants will be able to: List the most important

pneumococcal polysaccharide and conjugate vaccines Describe current Advisory Committee on Immunization

dedicated to educating the public and healthcare professionals about causes, treatment, and prevention of

Coalition-building activities Public and professional educational programs Scientific meetings, research, and

4 Learning Objectives At the conclusion of this webinar, participants will be able to: List the most important pneumococcal diseases that may be vaccine-preventable Compare and contrast the characteristics of pneumococcal polysaccharide and conjugate vaccines Describe current Advisory Committee on Immunization Practices (ACIP) recommendations for pneumococcal vaccination 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, health professionals, and media through: Coalition-building activities Public and professional educational programs Scientific meetings, research, and training Longstanding partnerships to facilitate rapid program initiation and increase programming impact Flexible and nimble organization 4

5 The Importance of Pneumococcal Vaccination Cynthia G. Whitney, MD, MPH Chief, Respiratory Diseases Branch Division of Bacterial Diseases National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention No conflicts to declare But a lot of help from: Monica M. Farley, MD Professor of Medicine/Infectious Diseases Director, Division of Infectious Diseases Emory University School of Medicine Matthew R. Moore, MD, MPH Captain, USPHS Centers for Disease Control and Prevention Nancy M. Bennett MD, MS Professor of Medicine and Public Health Sciences Director, Center for Community Health University of Rochester School of Medicine and Dentistry 5

6 Question #1: A healthy 65 year-old man presents to your office for a routine visit. ACIP currently recommends that he receive which of the following: A. Single dose of 23-valent pneumococcal polysaccharide vaccine. B.Single dose of 23-valent pneumococcal polysaccharide vaccine every 5 years. C.Single dose of 13-valent pneumococcal conjugate vaccine followed by a single dose of 23-valent pneumococcal polysaccharide vaccine 12 months later. D.Either 23-valent pneumococcal polysaccharide vaccine or 13-valent pneumococcal conjugate vaccine (not both). E.I don t know but how can I get those abs? Question #1: A healthy 65 year-old man presents to your office for a routine visit. ACIP currently recommends that he receive which of the following: A. Single dose of 23-valent pneumococcal polysaccharide vaccine. B.Single dose of 23-valent pneumococcal polysaccharide vaccine every 5 years. C.Single dose of 13-valent pneumococcal conjugate vaccine followed by a single dose of 23-valent pneumococcal polysaccharide vaccine 12 months later. D.Either 23-valent pneumococcal polysaccharide vaccine or 13-valent pneumococcal conjugate vaccine (not both). E.I don t know but how can I get those abs? 6

7 Outline Pneumococcal Disease Pneumococcal Vaccines Considerations for Adults The New Yorker, July 5,

8 PNEUMOCOCCAL DISEASE Pneumococcus One Pathogen 8

9 Capsule = Vaccine Target >90 Types Kadioglu, Nature Reviews Microbiology 2008; 6: Pneumococcus One Disease 9

Incidence (cases per 100,000) Relationship Between Pneumococcal Colonization, Mucosal Disease, and Invasive Disease Transmission Mucosal disease Invasive disease Bogaert, Lancet Infect Dis

10 Incidence (cases per 100,000) Relationship Between Pneumococcal Colonization, Mucosal Disease, and Invasive Disease Transmission Mucosal disease Invasive disease Bogaert, Lancet Infect Dis 2004;4: Age-Specific Incidence of Invasive Pneumococcal Disease, US, Highest Risk Age Groups Comorbid conditions contribute 4 13 < Age (years) Robinson, JAMA 2001;285:

11 PNEUMOCOCCAL VACCINES Pneumococcal Vaccines Pneumococcal Polysaccharide (PPSV23) Introduced in1983 with moderate efficacy in prevention of invasive disease; inconsistent data re prevention of non-bacteremic pneumonia Pneumococcal Conjugate (PCV7, PCV13) PCV 7 introduced in children 2000 Remarkable impact on disease in all age groups PCV13 introduced in children 2010 (PCV10 not available in US) 11

12 Question #2: Clear advantages of pneumococcal conjugate vaccines over pneumococcal polysaccharide vaccines include all of the following except: 1. Conjugate vaccines prevent asymptomatic colonization by vaccine-type pneumococci; polysaccharide vaccines do not. 2. Conjugate vaccines have been demonstrated in multiple randomized, controlled clinical trials to prevent radiographic pneumonia; polysaccharide vaccines have not. 3. Conjugate vaccines have been shown to prevent infection among unvaccinated persons through vaccination of children; polysaccharide vaccines have not. 4. Antibodies induced by conjugate vaccines last longer than those induced by polysaccharide vaccines. Question #2: Clear advantages of pneumococcal conjugate vaccines over pneumococcal polysaccharide vaccines include all of the following except: 1. Conjugate vaccines prevent asymptomatic colonization by vaccine-type pneumococci; polysaccharide vaccines do not. 2. Conjugate vaccines have been demonstrated in multiple randomized, controlled clinical trials to prevent radiographic pneumonia; polysaccharide vaccines have not. 3. Conjugate vaccines have been shown to prevent infection among unvaccinated persons through vaccination of children; polysaccharide vaccines have not. 4. Antibodies induced by conjugate vaccines last longer than those induced by polysaccharide vaccines. 12

13 Polysaccharide & Conjugate Vaccines: A Comparison Characteristic Polysaccharide Conjugate Components Purified polysaccharide Purified polysaccharide covalently bound to carrier protein Immunogenic? Only among >2 year-olds All ages First year available Number of serotypes Effect against bacteremia Substantial Substantial Effect against carriage None Substantial Effect against nonbacteremic pneumonia No consensus Moderate Schedule <3 doses after age 2 years 4 doses <age 2 years; possibly 1 after Cost US $55 US $124 Examples 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) 7-Valent & 13-Valent Pneumococcal Conjugate Vaccines (PCV7, PCV13) Active Bacterial Core Surveillance (ABCs, Emerging Infections Program) Total population in ABCs = 18.5 million Case definition: pneumococcus isolated from normally sterile site in surveillance area resident Chart review for clinical information Active contact with clinical laboratories to identify cases Audits ensure completeness of reporting Isolates serotyped at reference laboratories (CDC and MDH) 13

14 Cases per 100,000 Cases per 100,000 Rates of Invasive Pneumococcal Disease among Children <5 years, PCV7 introduction Overall 2007 vs. baseline All Serotypes: -76% (-79,-73) Year cases per 100,000 Rates of Invasive Pneumococcal Disease among Children <5 years, PCV7 introduction Overall Year PCV7 type 2007 vs. baseline All Serotypes: -76% (-79,-73) PCV7 Types: -99% (-100,-99) <1 case per 100,000 14

Cases per 100,000 Rates of Invasive Pneumococcal Disease Caused by 6 Serotypes in PCV13, But Not PCV7, Children <2 years, ABCs, 2001-09 30 25 19A 7F 6A 5 3 1 20 15 10

15 Cases per 100,000 Rates of Invasive Pneumococcal Disease Caused by 6 Serotypes in PCV13, But Not PCV7, Children <2 years, ABCs, A 7F 6A Year CDC, ABCs, continuous sites since 2001, unpublished What are indirect effects*? *sometimes called herd effects 15

16 Susceptible Population Susceptible Population 16

17 Susceptible Population Indirect Effects: Partially Vaccinated Population x x x 17

Cases per 100,000 population PCV7 introduction PCV13 introduction Rates of PCV7-serotype IPD among Adults, ABCs, 1998-2007 2007 vs.

18 Cases per 100,000 population PCV7 introduction PCV13 introduction Rates of PCV7-serotype IPD among Adults, ABCs, vs. baseline 65+: -92% (-94,-89) 50-64: -87% (-90,-83) 18-49: -91% (-93,-88) Incidence of IPD in Children <5 yrs. and Adults > 65 yrs <5 Overall <5 PCV Overall 65+ PCV

19 PNEUMOCOCCAL VACCINES CONSIDERATIONS FOR ADULTS Question #3: The FDA licensed PCV13 for all adults age 50 and older in 2011 based on non-inferior immunogenicity to PPSV23, and ACIP considered a recommendation at that time. Why did ACIP not recommend PCV13 for adults in 2011? A. Why bother? Herd effects from vaccinating children might take care of disease in adults. B. Efficacy against pneumonia in adults was unknown; a clinical trial (CAPITA) was underway. C. PCV13 was not thought to be cost-effective compared to PPSV23. D. A and B E. All of the above 19

20 Question #3: The FDA licensed PCV13 for all adults age 50 and older in 2011 based on non-inferior immunogenicity to PPSV23, and ACIP considered a recommendation at that time. Why did ACIP not recommend PCV13 for adults in 2011? A. Why bother? Herd effects from vaccinating children might take care of disease in adults. B. Efficacy against pneumonia in adults was unknown; a clinical trial (CAPITA) was underway. C. PCV13 was not thought to be cost-effective compared to PPSV23. D. A and B E. All of the above ACIP Pneumococcal Work Group Activities PCV13 recommended for adults 65+ years old Routine recs for infants and children; permissive recs for 6-18 years olds with IC Deferred routine recs for adults pending results of CAPITA and indirect effects Recommendations for adults with IC Recommendations for 6-18 years olds with IC Feb 2010 Dec 2011 Feb 2012 Jun 2012 Jan 2013 Feb 2013 Aug 2014 PCV13 licensed (replaced PCV7) PCV13 licensed for adults > 50 years old PCV13 licensed for children 6-17 years old IC = with immunocompromising conditions, functional or anatomic asplenia, CSF leaks, or cochlear implants 20

21 Relative Risk of IPD PNEUMOCOCCAL CONJUGATE VACCINE IN IMMUNOCOMPROMISED ADULTS Chronic Illnesses Increase the Risk for IPD Healthy (Referent) 3.4 Diabetes Lung Disease Cardiac Disease 11.4 Alcoholism 38.3 Hematologic Cancer 48.4 HIV/AIDS Kyaw, JID 2005;192:

22 Findings: 75% reduction in vaccine type IPD Non-significant trend toward reduction in risk of all cause pneumonia. N Engl J Med 2010;362: Risk Group Underlying Medical Condition PCV13 PPSV23 Recommended Recommended Revaccination at 5 years Immunocompetent persons Chronic heart disease Chronic lung disease Diabetes mellitus CSF leaks Cochlear implants Alcoholism Chronic liver disease Persons with functional or anatomic asplenia Immunocompromised persons Cigarette smoking Sickle cell disease/other hemaglobinopathies Congenital or acquired asplenia Congenital or acquired immunodeficiencies HIV infection Chronic renal failure Nephrotic syndrome Leukemia Lymphoma ACIP Recommendations MMWR Oct 12, 2012 Hodgkin disease Generalized malignancy Iatrogenic immunosuppression Solid organ transplant Multiple myeloma 22

23 What next? Should PCV13 be recommended for healthy adults >65 years of age? ACIP 2012: Considerations Grading of Recommendations, Assessment, Development and Evaluation (GRADE): Evidence type/quality low (type 3) Licensure based on non-inferior immunogenicity Limited studies on efficacy against IPD (1 RCT in HIV+ adults) No data on efficacy against pneumonia Magnitude of expected health benefits and costeffectiveness unclear Efficacy against pneumonia? Net benefits given indirect/herd immunity? Cost-effectiveness results sensitive to PCV13 efficacy against pneumonia and expected herd effects 23

Non-bacteremic pneumonia Said, PLOS One 2013, DOI: 10.

0060273 ACIP 2012: Conclusions Await results of CAPiTA

expected to be available by 2013 (turned out to be 2014)

24 For every 1 of these....there are 3 of these Bacteremic pneumonia Non-bacteremic pneumonia Said, PLOS One 2013, DOI: /journal.pone ACIP 2012: Conclusions Await results of CAPiTA (trial of PCV13 on pneumonia and IPD in older adults)-- expected to be available by 2013 (turned out to be 2014) Continue to review indirect effects on disease in adults to provide data on preventable disease and cost-effectiveness of administering PCV13 to healthy adults 24

25 Randomized, placebo-controlled trial of 85,000 adults >65yrs of age in the Netherlands Primary endpoint: vaccine-type communityacquired pneumonia Neth J Med 2008;66: CAPiTA: Cumulative Episodes of Efficacy End Points in the Per-Protocol Population Vaccine efficacy 46% (22%, 63%) Vaccine efficacy 75% (41%, 91%) What effect might we expect among persons >65 years old in the US? Bonten MJ et al. N Engl J Med 2015;372:

26 ACIP August 2014: Summary of evidence supporting PCV13 use among adults >65 years of age Prevents IPD and non-bacteremic pneumonia 1 75% reduction in vaccine type IPD 46% reduction in vaccine type non-bacteremic pneumonia Immune response non-inferior or improved (for some serotypes) for PCV13 (or PCV7) vs. PPSV23 2,3 Safety demonstrated in clinical trials GRADE evaluation demonstrated strong quality evidence (type 2) 1 CAPITA, June 2014 ACIP 2 Phase III trials, Pfizer, ACIP 2011, DeRoux et al. CID 2008, Goldblatt et al 2009 What about the need? Estimated US cases without direct PCV13 use in adults Outcome (PCV13 type) (20% reduction due to herd effects*) 2019 (86% reduction due to herd effects*) IPD 2,660 2, Inpatient CAP 56,380 45,100 7,890 Outpt CAP 82,410 65,930 11,540 Total CAP 138, ,030 19,430 *Based on post-pcv7 experience Key point: benefits of direct PCV13 use among adults will likely decline over time 26

Expected Public Health Impact and Cost- Effectiveness Various strategies considered and evaluated for expected public health impact and cost-effectiveness Vaccination at ages 50, 60, and 65 years

comparable to other adult interventions accepted as cost-effective (base case) Cost-effectiveness likely to decrease over time Stoecker C et al.

27 Expected Public Health Impact and Cost- Effectiveness Various strategies considered and evaluated for expected public health impact and cost-effectiveness Vaccination at ages 50, 60, and 65 years PCV13 instead of PPSV23 PCV13 in sequence with PPSV23 Adding PCV13 at age 65 years to existing PPSV23 recommendations likely the optimal strategy Health benefits for all outcomes Cost-effectiveness comparable to other adult interventions accepted as cost-effective (base case) Cost-effectiveness likely to decrease over time Stoecker C et al. ACIP 2014 Both PCV13 and PPSV should be routinely administered to all adults aged > 65 years. Recommendations for adults with immunocompromising and high risk conditions unchanged (already include PCV13) This recommendation will be reevaluated in 2018 and revised as needed. 27

28 Percent of invasive cases Why both? Percent of Invasive Pneumococcal Cases Caused by Serotypes in Different Vaccine Formulations, PCV7 PCV13 PPV to to Age Group, years ABCs unpublished data,

29 Pneumococcal vaccine-naïve persons. Adults aged 65 years who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23. The dose of PPSV23 should be given 6 12 months after a dose of PCV13. Pneumococcal vaccine-naïve persons. Adults aged 65 years who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23. The dose of PPSV23 should be given 6 12 months after a dose of PCV13. X Update: MMWR September 4, 2015 A dose of PPSV23 should be given 1 year following a dose of PCV13. The two vaccines should not be co-administered. If a dose of PPSV23 is inadvertently given earlier than the recommended interval, the dose need not be repeated. 29

30 Question #4: Why should PCV13 be given before PPSV23 for patients who have never received a pneumococcal vaccine? A. Fewer adverse reactions B. Better immune response for PCV13 C. Better immune response for PPSV23 D. All of the above Question #4: Why should PCV13 be given before PPSV23 for patients who have never received a pneumococcal vaccine? A. Fewer adverse reactions B. Better immune response for PCV13 C. Better immune response for PPSV23 D. All of the above..but those who have already received PPSV23 should still get PCV13 30

31 Question #5: A 67 year-old man with no underlying medical conditions is in your office 12 months after receiving PCV13. Should you give him PPSV23 today? A. Of course. B. No way. C. Not sure. Flip a coin. D. It depends Question #5: A 67 year-old man with no underlying medical conditions is in your office 12 months after receiving PCV13. Should you give him PPSV23 today? A. Of course. B. No way. C. Not sure. Flip a coin. D. It depends Bonus: what does it depend on? 31

32 Question #5: A 67 year-old man with no underlying medical conditions is in your office 12 months after receiving PCV13. Should you give him PPSV23 today? A. Of course. B. No way. C. Not sure. Flip a coin. D. It depends Bonus: what does it depend on? PPSV23 History PPSV23 received at age 65 years PPSV23 PCV13 Today Age, years No more pneumococcal vaccines ever 32

33 Persons who previously received PPSV23 at age >65 years PPSV23 already received at age 65 years PCV13 1 years Persons who previously received PPSV23 before age 65 years who are now aged >65 years PPSV23 already received at age < 65 PCV13 at age 65 years PPSV23 1 year 1 year 5 years 33

34 Summary Pneumococcal disease a problem across the age spectrum Conjugate vaccines have had a large impact on disease Conjugate vaccines recommended for Infants People of all ages with immunocompromising conditions Adults >65 years Preference for PCV13 followed by PPSV23 for adults Recommended interval for adults 12 months Adult recommendations may change in the future depending on prevalence of PCV13 serotypes California EIP Art Reingold Duc Vugia James Watt Gretchen Rothrock Pam Daily Joelle Nadle Mirasol Apostol Katie Wymore Lauren Pasutti Erin Garcia Erin Parker Mariah Hamilton Nick Czap Colorado EIP Ken Gershman Deborah Aragon Jen Sadlowski Ben White Wendy Bamberg Connecticut EIP Matt Carter Terry Rabatsky-Ehr Heather Altier Susan Petit Carmen Marquez Michelle Wilson Georgia EIP Monica Farley Wendy Baughman Janine Ladson Amy Holst Stepy Thomas Sasha Schlicher Suzanne Segler Lauren Lorenztson Matt Crist Jessica Reno Lewis Perry Calista Schenck Melissa Tobin D Angelo Acknowledgements Maryland EIP Lee Harrison David Blythe Patricia Ryan Rosemary Hollick Joanne Benton Terresa Carter Kim Holmes Kathleen Shutt Lindsay Saxman Andrea Riner Mary Messenger Helen Yoon Carolyn Kreiner Minnesota EIP Richard Danila Ruth Lynfield Catherine Lexau Lori Triden Brenda Jewell Lindsay Lesher Corinne Holtzmann Christine Lees Craig Morin Lisa Dunning Valerie Solovjoys Billie Juni New Mexico EIP Joan Baumbach Megin Nichols Joseph Bareta Sarah Khalnlian Robert Mansmann Lisa Butler Kathy Angeles Gabriela Keener New York EIP Gus Birkhead Nancy Bennett Deb Blog Shelley Zansky Nancy Spina Glenda Smith Jillian Karr Suzanne Solghan Kari Burzlaff Salvatore Currenti Greg Giambrone Nellie Dumas Kimberlee Musser Ghinwa Dumyati Anita Gellert Gary Hollick Oregon EIP Paul Cieslak Ann Thomas Jamie Thompson Carmen Ford-Treacy Rachel Linz John Townes Tennessee EIP William Schaffner Mary Lou Lindegren Tim Jones Brenda Barnes Mellnda Eady Terri McMinn Katie Gore Lynne Fenner Sandra Gray Lura McKnight Wendi Welch Karen Leib Henrietta Hardin CDC Contract Lab- TX James Jorgensen Lettie McElmeel CDC ABCs Team Gayle Fischer Langley Chris Van Beneden Emily Weston Londell McGlone Carolyn Wright Karrie-Ann Toews Ruth Link-Gelles Ryan Gierke Tamar Pilishvili Cyndy Whitney Matt Moore Stephanie Schrag Nancy Messonnier Amanda Cohn Elizabeth Briere Jessica MacNeil Tami Skoff Amanda Faulkner Elizabeth Zell Tom Taylor Melissa Lewis Tracy Pondo Scott Fridkin Fernanda Lessa Sandie Bulens Shierley Zhang Ruth Belflower Bernie Beall Lesley McGee Logan Sherwood Dee Jackson Leonard Mayer Jennie Thomas Raydel Mair Greg Fosheim Valerie Schoonover Thank you! 34

35 Happy Vaccinating!! Thank you Questions? 69 Questions & Answers 35

36 CME 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. 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 Join us for upcoming NFID CME Webinars Updates from February 2016 ACIP Meeting Friday, March 4, 12:00 PM ET Vaccines for Immunocompromised Adults Tuesday, April 5, 12:00 PM ET Shingles Vaccines: What You Need to Know Tuesday, May 3, 12:00 PM ET Travel Vaccines: Know Before You Go Wednesday, June 1, 12:00 PM ET Register: Subscribe for updates: 36

Impact of pneumococcal conjugate vaccine: US experience Stephanie Schrag Centers for Disease Control and Prevention Atlanta, GA

Impact of pneumococcal conjugate vaccine: US experience Stephanie Schrag Centers for Disease Control and Prevention Atlanta, GA San Jose, Costa Rica, August 2007 Pneumococcal Conjugate Vaccine Introduction