Vaccine Safety and Vaccine Safety Communication

1. Vaccine Safety and Vaccine Safety Communication Otherwise Known as The Vaccine Wars

2. Objectives • List some of the events that led to the current climate of vaccine safety concern • Describe factors that contribute to parental concerns about vaccines • Develop talking points to address common myths about vaccine safety • Develop answers to the question-What is wrong with an alternative vaccine schedule?

3. Vaccination is the top Public Health achievement of the 20th Century MMWR 1999; 48:241

4. CDC, Epidemiology and Prevention of Vaccine-Preventable Diseases, 9th ed., 2006

5. Vaccine-Preventable Diseases:Baseline 20th Century & Current Morbidity *provisional MMWR 1999;48:245, 2011;59:1700

7. The Things You Hear… Are vaccines safe? Vaccines and autism MMR Thimerosal Other vaccine ingredients Vaccines in general Too many vaccines overwhelm the immune system Diseases no longer exist—or aren’t that dangerous It is all a giant money-fueled conspiracy Individual rights vs. public health needs

8. Parental Vaccine Safety Concerns Freed et al, Pediatr 2010;125:654

9. Parents: Doubts About Vaccines Gust et al Pediatr 2009;122:718

10. Why Parents Who Planned To Delay/Refuse Vaccine Changed Their Minds Gust et al Pediatr 2009;122:718

11. How did we get here?

12. Real Vaccine Risks • 1950-1980’s: Whole cell DTP vaccine • 1976: Guillain-Barré from influenza vaccine • 1980’s: OPV causing paralysis despite no cases of polio • 1990’s: intussusception from rotavirus vaccine

13. How have we dealt with real vaccine risks?

14. Responses to real vaccination risks and problems • Elimination of killed measles vaccine • Transition from plasma derived Hep B vaccine to recombinant Hep B vaccine • Transition from DTP to DTaP (Some countries suspended pertussis immunization) • Transition from OPV to IPV • Withdrawal of first rotavirus vaccine

16. Will H1N1 Influenza Vaccine Cause Guillain-Barre Syndrome?

17. H1N1 Influenza Vaccine Safety Closely monitored by CDC and National Vaccine Program Office Multiple large population databases scoured for adverse events related to H1N1 vaccine Vaccine Safety Datalink VA Health System and Dept. of Defense PRISM Health Plan/Immunization Registry link Indian Health Service Emerging Infections Program More than 10 million post-H1N1 vaccination lives under observation

19. 1998-99: The Vaccine Safety Concern 1-2 Punch

20. Wakefield History Wakefield, A.J., et al. Lancet 351: 637-641, 1998

21. Thimerosal-the beginning MMWR 1999; 48 (26):564-566

22. Wakefield…and the rest of the story • Findings never reproduced • Wakefield had serious financial conflicts • Co-authors withdraw from paper • Paper retracted from Lancet • Hearings held by British Health Authorities • Wakefield sanctioned and license revoked • The details of ”an elaborate fraud” published in the British Medical Journal

24. Thimerosal history Mercury content of recommended vaccines reviewed Recommendation to reduce mercury exposure Delay in Hepatitis B vaccination of newborns to minimize mercury exposure Once MMR couldn’t be targeted as a cause of autism, thimerosal became an attractive target

25. Factors that have increased concern Distrust Industry Government Doctors Uncertainty Rapid increase in the number of vaccines Rapid increase in the number of autism cases Internet/Media/Celebrities

26. Know Your Source

28. What has been the effect? Falsehood flies, and the truth comes limping after; so that when men come to be undeceived, it is too late: the jest is over and the tale has had its effect Jonathan Swift, The Examiner Nov. 9, 1710

29. Permanent Medical Exemptions & Personal Beliefs Exemptions, Kindergarten Students, California Lee et al NVIC 2010

31. Kindergarten PBEs by County 2000 2008 Lee et al NVIC 2010

33. San Diego Measles Outbreak 2008 Physician Office <12 months old Charter School 2º Transmission

34. Other Measles Outbreaks in the U.S.-2008 • 131 cases from Jan-June 2008 (Average cases =63 annually 2000-2007) • Washington outbreak (n=19) included 16 school-aged children-all unimmunized • Illinois outbreak (n=30) included 25 school-aged children-all unimmunized • Altogether 91% of cases were unimmunized • 89% related to imported cases MMWR 2008; 57:893

36. …and in 2011 • Measles outbreak in Minnesota centered in Somali population • Measles in Utah • Measles in Arizona • Large mumps outbreak in New Jersey 2010 • California pertussis outbreak-10 deaths MMWR, 2011; 60(20):666-668 MMWR 2010;59:125-129

37. Individual Risk of Exemption - Pertussis Age Group Rate per Rate per Relative Risk 100,000 100,000 (95% CI) exemptors vaccinated 3 - 5 191 11 17 (9 - 31) 6 - 10 142 9.4 15 (9 - 25) 11 - 14 35 19 1.9 (0.8 - 5) 15 - 18 0 13 0 (0 - 2) 3 - 18 80 13 5.9 (4 - 8) Feikin, JAMA, 2001;284:3145

38. Refused pertussis vaccination • 22.8 times increased risk of pertussis

39. Refused varicella vaccination • 8.6 times increased risk of varicella

40. Other Vaccine Components and AutismIt ain’t over ‘til the fat lady sings… Aluminum Bovine serum albumen Adjuvants Yeast proteins Human cell line derivatives …………………..

41. How Can You Respond

42. How can you respond? Are vaccines safe? Do vaccines cause autism? Aren’t we overwhelming the immune system? Isn’t natural immunity better? Diseases no longer exist—or aren’t that dangerous It is all a giant money-fueled conspiracy It’s my right to decide what’s best for my child

43. Parental Immunization Refusal • Listen carefully to concerns • encourage questions • Discuss known risks and benefits • risks to unimmunized child • Concerns about specific vaccines • discuss • administer other vaccines • Multiple injection concerns • modify schedule • Revisit discussion in future visits • Document

44. Vaccine Safety Discussion Strategies • Empathize: acknowledge that there are many conflicting messages in the media • Assess level of scientific evidence desired • Maximize benefits to their child • not a public health discussion • vaccines provide protection • risk of disease for omitted vaccines • Use personal stories • Provide appropriate resources • e.g., CDC, AAP, NNII, CHOP

45. The Vaccine Safety Infrastructure

46. Vaccines are Safe Talking Points Hundreds of millions of vaccines are given every year in U.S. with no problem Billions of vaccines are given in the world every year with no problem Vaccine safety infrastructure is large VAERS VSD CISA FDA CDC

47. Sample Sizes Needed During Clinical Trials to Detect Increases in Rates of Rare Vaccine Adverse Events * Two-arm, power=80%, alpha (2 sided)=5% 1 If the entire birth cohort (approx. 4 million children) received the vaccine each year Adapted from Ellenberg SS: Safety considerations for new vaccine development. Pharmacoepidemiol Drug Safety 10(5):411-5, 2001

48. Vaccine Adverse Events Reporting System (VAERS) National post-licensure safety surveillance system jointly operated by CDC and FDA Spontaneous reporting system in existence since 1990 reports submitted by clinicians, manufacturers, patients/parents and others Subject to well-described limitations of passive surveillance

49. VAERS Advantages covers US population permits monitoring for known adverse events detects signals for previously unrecognized/rare adverse events generates hypothesis Limitations risk of underreporting or over reporting incomplete data lack of availability of denominator data