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From the Novel to the Nonsensical: Vaccine Updates and the Anti-Vaccine Movement

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From the Novel to the Nonsensical: Vaccine Updates and the Anti-Vaccine Movement
Mark P. Walberg, PharmD, PhD, CTH

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From the Novel to the Nonsensical: Vaccine Updates and the Anti-Vaccine Movement

  1. 1. From the Novel to the Nonsensical: Vaccine updates and the Antivaccine Movement Mark P. Walberg, Pharm.D., Ph.D., CTH Associate Professor of Pharmacy Practice Regional Coordinator, San Fernando Valley-Los Angeles Region University of the Pacific Thomas J. Long School of Pharmacy and Health Science
  2. 2. Financial Disclosures • Mark P. Walberg, PharmD, PhD, CTH discloses the following relationships: • Previously employed as a paid speaker for Merck Vaccines • Currently retained as a paid legal consultant for Merck Vaccines • Currently employed by GlaxoSmithKline • This conflict has been resolved per ACPE best practices
  3. 3. Statement of Need • In order to be compliant with California regulations, California pharmacists must abide by the current immunization recommendations from the Advisory Committee on Immunization Practices that will be covered herein. • Additionally, immunizing pharmacists must complete biannual continuing education on vaccines and as is fulfilled by this course.
  4. 4. Course Objectives • Review the current vaccine schedules from the Advisory Committee on Immunization Practices (ACIP) and highlight changes from previous schedules. • Discuss rationale behind current influenza vaccine recommendations from ACIP. • Discuss the efficacy and safety of novel adjuvanted vaccines and the immunological rationale behind their use. • Assess vaccination requirements for patients using the current ACIP recommendations and HALO model. • Review common vaccine misconceptions and evidence that refutes them. • Identify verbiage and imagery commonly used to frighten patients away from receiving vaccines. • Compare clinical trial data and epidemiological evidence of an association between vaccines and autism. • Discuss various mechanisms in place to report and monitor vaccine adverse events.
  5. 5. Influenza Update
  6. 6. Comparison of 2018-19 Influenza Season
  7. 7. 2018-19 Influenza Season
  8. 8. Question… Why not just vaccinate using every known strain of influenza each season to provide the most protection?
  9. 9. How Flu Vaccines are Determined, Part 1 WHO reports on: • Epidemiological data monitored for most common viruses in circulation • Recommends specific viruses to be included for countries in northern or southern hemispheres • Report typically published in March
  10. 10. How Flu Vaccines are Determined, Part 2 CDC confirms which strains will be included • Typically published in June with reported effectiveness from prior season • Recommendations for each season published in or around August
  11. 11. Interim Estimates of Effectiveness (2018-19)
  12. 12. “Maximum Effort” for Updates • Get updates sent to you, don’t try to seek them all out! • Centers for Disease Control and Prevention • Morbidity and Mortality Weekly Report (MMWR): https://www.cdc.gov/mmwr/mmwrsubscribe.html • All official CDC recommendations sent via MMWR, typically each Friday • Immunization Action Coalition (IAC) • “IAC Express”: http://immunize.org/subscribe/ • Also contains all Vaccine Information Statements in multiple languages and other useful handouts (e.g., HALO) • World Health Organization • World Epidemiological Record: https://www.who.int/wer/en/ • Equivalent to CDC’s MMWR, but global (obviously)
  13. 13. Newer Adjuvant Vaccines Heplisav-B Fluad Shingrix
  14. 14. Why Adjuvants? • Increase antigen uptake via non-specific immune response • Optimize B-cell maturation through enhancement of T- helper response
  15. 15. Newer Adjuvant Vaccines • Heplisav-B & Fluad • No preference for use over non- adjuvanted vaccines • Typically require either lower amount of antigens or fewer doses to elicit similar immune response • n.b., currently no data on concomitant administration with other adjuvanted vaccines, e.g., RZV • Currently recommendation is to avoid concomitant administration
  16. 16. Newer Adjuvant Vaccines
  17. 17. Newer Adjuvant Vaccines • If previously vaccinated with ZVL: • RZV administered at least 5 years after receipt of ZVL in clinical studies • Shorter intervals can be considered based on patient age or health factors • Expert opinion (per ACIP) is to wait at least two months after receipt of ZVL • No observed or theoretical efficacy or safety concerns with shorter intervals (but not studied)
  18. 18. Return of FluMist? • FluMist (LAIV) • Recommendation for use previously withdrawn due to low immunity induced against H1N1 in two seasons • Impaired immunity determined to be due to decreased replication in human nasal epithelium cells • New strain used and additional testing required, however: “Providers should be aware that the effectiveness of the updated LAIV4 containing A/Slovenia/2903 /2015 against currently circulating influenza A(H1N1)pdm09-like viruses is not yet known.”
  19. 19. • Only one dose of Tdap routinely recommended by ACIP • Revaccination of healthcare personnel with Tdap may be considered if there is an increased risk of exposure/current transmission • Could argue that the activity in the last few years in California would qualify… • Only exception is pregnancy Can we give more than one dose of Tdap?
  20. 20. • Why give Tdap with each pregnancy? • Amnestic (booster) response increases maternal antibodies • Recommended at 27-36 weeks when antibodies have greater flux through placental barrier • Recent study indicated that 27-30 weeks is most optimal for Ab transfer • Increase pertussis antibodies in newborn to decrease rate of pertussis through passive immunity Can we give more than one dose of Tdap? 𝐽 ∝ 𝑃 ∆𝐶 𝑥 Remember Fick’s Law of Diffusion?
  21. 21. • Only 9-valent vaccine now available • FDA indication up to 45 years of age based on immunogenicity and safety • ACIP has not recommended it above 26 as there is no evidence it prevents cancer in adults already infected with HPV. • Long-term safety data and evidence of herd immunity available… Changes & Expanded Use for HPV Vaccine
  22. 22. • Recommended for use in individuals who are experiencing homelessness • Check with your local public health department… Additional recommendation for HepA vaccine
  23. 23. Another way to look at it… HALO
  24. 24. Patient Case – The Community Patient • Male patient, 53 years of age • Filling first prescriptions for metformin, lisinopril and atorvastatin • Just diagnosed with type 2 diabetes mellitus, hypertension and hyperlipidemia • No vaccines since childhood 1. Which vaccines do you give now? 2. Which vaccines do you give later and when?
  25. 25. Patient Case – The Hospitalized Patient • Male patient, 48 years of age • About to be discharged from hospital after 3 day stay for first COPD exacerbation • Diagnosis made following ER visit for suspected pneumonia. • Other current conditions include hypertension, GERD, and chronic alcohol use (Ammonia, ALT, AST above ULN on admission) • Vaccination history includes: • Tdap in 2008 1. Which vaccines do you give now? 2. Which vaccines do you give later and when?
  26. 26. Patient Case – The Experienced Patient • Female patient, 72 years of age • Receives flu shots each year for past 4-5 years • Medical history includes: • Breast cancer (3 years post lumpectomy, no chemotherapy needed) • Osteoporosis • Vaccination history includes: • VZL in 2012 • Tdap in 2015 • PCV13 in 2016 followed by PPSV23 in 2017 1. Which vaccines do you give now? 2. Which vaccines do you give later and when?
  27. 27. Patient Case – The Pregnant Patient • Female patient, 32 years of age • Week 30 of 2nd pregnancy, no chronic conditions present • Vaccination history includes: • Tdap 3 years prior • Influenza vaccine in October of last year • HPV(4?) dose #1 at 25 years of age 1. Which vaccines do you give now? 2. Which vaccines do you recommend for mom post-partum? 3. Should you ask about anyone else’s vaccine status?
  28. 28. Part II: Refuting the anti-vaccine movement … or using the internet to refute the internet…
  29. 29. My take on the internet… e.g., biases… • The internet is neutral • It is full of information, both accurate and incorrect. • Information is not the same thing as knowledge. • An ignorant person armed with random facts who posts on the internet is like giving a TV show to the village idiot. • The greatest skill we can teach is discernment of fact from fiction so we can use the right information to gain knowledge.
  30. 30. No memes were harmed… Statistics will be used…
  31. 31. Some common themes… • Scare tactics and how medicine shoots its own foot • Spooky language • Math hard… But you can always lie with statistics • MMR and Autism… yes, the “debate” is still “raging”
  32. 32. Positive media… doesn’t always help…
  33. 33. Fire the marketing director…
  34. 34. OSHA come quickly…
  35. 35. This was from a pharmacy organization…
  36. 36. How to do it right…
  37. 37. Vaccine ingredients are regularly published…
  38. 38. Grapes 22.4 ug Hg/g Fluzone < 100 ug/0.5ml Rat LD50 = 25000mg/kg Most common metal ???????
  39. 39. Measles... still alive and well…
  40. 40. True or False? Measles does not have any serious sequelae and only causes a febrile rash. The original research that showed an associate between MMR and autism was a valid epidemiological study. Prevention of measles outbreaks requires approximately 95% of individuals to be vaccinated.
  41. 41. Global Perspective
  42. 42. Complications of Measles
  43. 43. Cost-Benefit of Vaccination
  44. 44. Question… Which of the following statements best describes the evidence for a link between vaccines and autism? A. There are a significant number of publications that have causally linked them. B. There are a significant number of publications that have shown an epidemiological correlation between them. C. There are a significant number of publications that have shown no association between them. D. There is a lack of evidence to make a conclusion either for or against an association or causation.
  45. 45. Evidence for a Link to Autism in 1998
  46. 46. May 2, 1998…2 months after the Wakefield articles was published…
  47. 47. Correlation…
  48. 48. Correlation…
  49. 49. Correlation…
  50. 50. Correlation…
  51. 51. Correlation…
  52. 52. Correlation…
  53. 53. Institute of Medicine Reports • Contents of an Institute of Medicine (IOM) Report • Epidemiological assessment of the adverse event • Clinical and observational/ecological studies of the adverse event • Assessment of the probable or possible mechanism of causality • Case reports (including passive reporting systems [e.g., VAERS]) that contribute to mechanistic assessment
  54. 54. Institute of Medicine Reports • Causality conclusion given for each adverse event based on evidence at hand • Convincingly supports • Favors Acceptance • Cannot be accepted or rejected • Favors Rejection
  55. 55. IOM Reports Concerning Measles (MMR) • 2001: MMR and Autism • 2004: Vaccines and Autism • 2012: Adverse Effects of Vaccines
  56. 56. IOM Reports Concerning Measles (MMR) • 2001: MMR and Autism • Rejected causal relationship between MMR and autism • No epidemiological evidence at a population level • Original case series [Wakefield, et.al. 1998] did not contribute to any causality • Fragmented biological models
  57. 57. IOM Reports Concerning Measles (MMR) • 2004: Vaccines and Autism • Rejected causal relationship between MMR and autism (again) • Rejected causal relationship between thimerasol and autism • Biological links between vaccines and autism are theoretical only • Reaffirmed the need to continue to examine any possible links between autism and vaccines • Reaffirmed surveillance of vaccine-related adverse events
  58. 58. Institute of Medicine Reports • 2012: Adverse Effects of Vaccines • Support for anaphylaxis, febrile seizures, and measles inclusion body encephalitis • Favorable acceptance for transient arthralgias in women and children • Rejection of causality to autism (again) and type 1 diabetes due to a large amount of epidemiological evidence and a lack of mechanistic plausibility
  59. 59. Subsequent Research to IOM Reports Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism
  60. 60. Measles Vaccine Effectiveness MMR Vaccination Began (1963)
  61. 61. Measles Vaccine Effectiveness?
  62. 62. Vaccine Effectiveness…?
  63. 63. Vaccine Effectiveness… Requires vaccination…
  64. 64. Measles continues to break out… • Officials in anti-vaccination ‘hotspot’ near Portland declare an emergency over measles outbreak • https://www.washingtonpost.com/nation/2019/01/23/an-anti-vaccination-hotspot-near- portland-suffers-public-health-emergency-over- measles/?noredirect=on&utm_term=.d1e9702f4720 • 23rd measles patient is another unvaccinated child in Vancouver area • https://www.oregonlive.com/clark-county/2019/01/23rd-measles-patient-is-another- unvaccinated-child-in-vancouver-area.html • New York confronts its worst measles outbreak in a decade • https://www.nytimes.com/2019/01/17/nyregion/measles-outbreak-jews- nyc.html?module=inline • Washington State Officials Declare State Of Emergency As Measles Outbreak Continues • https://www.npr.org/2019/01/28/689549375/washington-state-officials-declare-state-of- emergency-as-measles-outbreak-contin
  65. 65. >1.5 MILLION deaths averted in 2016 >20 MILLION deaths averted in 16 years
  66. 66. Questions? mwalberg@pacific.edu
  67. 67. Literature Cited Baxter R, et.al. Effectiveness of Vaccination During Pregnancy to Prevent Infant Pertussis. Pediatrics 2017;139(5):e20164091. CDC. Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps, 2013: Summary Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR June 14, 2013;62(RR04):1-34. CDC. Measles Outbreak — Minnesota April–May 2017. MMWR July 14, 2017;66:713-7. CDC. Progress Toward Regional Measles Elimination — Worldwide, 2000–2016. MMWR October 27, 2017;66(42):1148-53. CDC. Recommendations of the advisory committee on immunization practices for use of Hepatitis A vaccine for persons experiencing homelessness. Morb Mortal Wkly Rep. 2019;68(6):153-6. CDC. Weekly U.S. Influenza Surveillance Report. Reviewed, Updated & Accessed 2/22/2019. Available from: https://www.cdc.gov/flu/weekly/index.htm Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR Morb Mortal Wkly Rep 2018;67:103–108. DOI: http://dx.doi.org/10.15585/mmwr.mm6703a5 Doyle JD, Chung JR, Kim SS, et al. Interim Estimates of 2018–19 Seasonal Influenza Vaccine Effectiveness — United States, February 2019. MMWR Morb Mortal Wkly Rep 2019;68:135–139. DOI: http://dx.doi.org/10.15585/mmwr.mm6806a2 Gardasil 9 [Package Insert]. Whitehouse Station, NJ: Merck & Co., Inc.; October 2018.
  68. 68. Literature Cited Garten R, Blanton L, Elal AI, et al. Update: Influenza Activity in the United States During the 2017–18 Season and Composition of the 2018–19 Influenza Vaccine. MMWR Morb Mortal Wkly Rep 2018;67:634–642. DOI: http://dx.doi.org/10.15585/mmwr.mm6722a4 Grohskopf LA, Sokolow LZ, Broder KR, Walter EB, Fry AM, Jernigan DB. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season. MMWR Recomm Rep 2018;67(No. RR-3):1– 20. DOI: http://dx.doi.org/10.15585/mmwr.rr6703a1 Grohskopf LA, Sokolow LZ, Fry AM, Walter EB, Jernigan DB. Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) — United States, 2018–19 Influenza Season. MMWR Morb Mortal Wkly Rep 2018;67:643–645. DOI: http://dx.doi.org/10.15585/mmwr.mm6722a5 Healy CM, et.al. Association Between Third-Trimester Tdap Immunization and Neonatal Pertussis Antibody Concentration. JAMA. 2018;320(14):1464-1470. doi:10.1001/jama.2018.14298 Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press, 2012. Jain A, et.al. Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism. JAMA. 2015;313(15):1534-40. Kim DK, Hunter P. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2019. MMWR Morb Mortal Wkly Rep 2019;68:115–118. DOI: http://dx.doi.org/10.15585/mmwr.mm6805a5
  69. 69. Literature Cited Marshall, Gary S. The Vaccine Handbook: A Practical Guide for Clinicians. (Current edition). West Islip, NY: Professional Communications, Inc.; available online at: http://www.immunize.org/vaccine-handbook/ Murch SH, et.al. Retraction of an interpretation. Lancet 2004;363:750. National Research Council. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism. Washington, DC: The National Academies Press, 2001. (ISBN: 978-0-309-07447-6) National Research Council. Immunization Safety Review: Vaccines and Autism. Washington, DC: The National Academies Press, 2004. Offit PA, et.al. Pediatrics 2002;109(1):124-9. Peltola H, et.al. No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study. Lancet 1998;351:1327-8. Wakefield, AJ, et.al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998;351:637-41. [RETRACTED] WHO. Recommended composition of influenza virus vaccines for use in the 2018–2019 northern hemisphere influenza season. WER 2018 (12);93:133-52.

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