Understanding and Managing Vaccine Concerns Julie A Boom

Understanding and Managing Vaccine Concerns Julie A. Boom, MD Associate Professor of Pediatrics, Baylor College of Medicine Director, Immunization Project, Texas Children’s Hospital Pediatrics

Objectives • Describe the history of vaccine refusal • Examine misinformation that leads to vaccine refusal • Discuss vaccine hesitancy epidemiology • Describe alternative immunization schedules and why they aren’t recommended • Apply “CASE” method to office discussions Pediatrics Page 1 xxx 00. #####. ppt 12/7/2020 9: 22: 14 AM

Brief History of Vaccine Concerns Pediatrics

Concerns about variolation included: • Idea that intentional disease exposure could make a person healthier was counterintuitive. • Intentional exposure was a violation of God’s will; one should die a “natural death” and not change the course of natural events. • Fears of contracting the disease or dying from the vaccine.

“Pro‐inoculators” Mather, Colmon and Boylston “Anti‐inoculators” William Douglass and Franklins http: //nationalhumanitiescenter. org/pds/becomingamer/ideas/text 7/smallpoxvaccination. pdf

Fatality of natural and inoculated smallpox BOSTON a ENGLAND b Died Survived Natural smallpox 844 4915 2848 19303 Inoculated smallpox 6 276 13 611 c a. relative risk natural vs inoculated smallpox: 6. 9 (range 3. 2– 15) p <. 0011 b. relative risk natural vs inoculated smallpox: 8. 0 (range 4. 7 -13. 6) p <. 0011 c. relative risk inoculated in Boston vs England: 1. 02 (range 0. 4– 2. 6) p >. 9 Boylston AW, Williams AE (2008). Zabdiel Boylston’s evaluation of inoculation against smallpox. JLL Bulletin: Commentaries on the history of treatment evaluation (www. jameslindlibrary. org).

The Cutter Incident

Barbara Loe interviewed by Regis and Kathy Lee http: //www. youtube. com/watch? v=-2 b 0 -h. MGm-o

The modern American anti‐vaccine movement Dissatisfied Parents Together National Vaccine Information Center (NVIC)

Review of alleged linkage • 1998 ‐ Wakefield published a case report of 12 children with IBD and regressive developmental delay • Hypothesis: MMR caused bowel dysfunction, which resulted in neurodevelopmental disorders • 2004 ‐ 10 of Wakefield’s original 13 authors published a formal retraction • 2010 ‐ Lancet retracts study • 2011 ‐ BMJ investigation labels Wakefield’s study “an elaborate fraud” and Wakefield’s medical license is revoked Pediatrics Page 9351, 637‐ 641 (1998) Wakefield, AJ et al. Lancet Murch S. Lancet 363, 821‐ 822 (2004) xxx 00. #####. ppt 12/7/2020 9: 22: 20 AM

Jenny Mc. Carthy http: //www. youtube. com/watch? v=HX-SCdj. DOr. A

http: //www. today. com/video/robert‐de‐niro‐pulls‐anti‐vaccine‐film‐from‐ tribeca‐film‐festival‐ 653408835987 Pediatrics Page 11 xxx 00. #####. ppt 12/7/2020 9: 22 AM

Pediatrics Page 12 xxx 00. #####. ppt 12/7/2020 9: 22: 24 AM

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Why MMR? A victim of timing… Pediatrics Page 14 xxx 00. #####. ppt 12/7/2020 9: 22: 29 AM

The body of evidence against an MMR‐autism link D’Souza, Y. et al. Pediatrics 118, 1664‐ 1675 (2006). Fombonne, E. & Charkrabarti, S. Pediatrics 108, E 58 (2001). Richler, J. et al. J. Autism Dev. Disord. 36, 299‐ 316 (2006). Taylor B. et al. Lancet 353, 2026‐ 2029 (1999). Chen, W. et al. Psychol. Med. 34, 543‐ 553 (2004). Kaye, J. A. , et al. BMJ 322, 460‐ 463 (2001). Dales, L. et al. JAMA 285, 1183‐ 1185 (2001). Honda, H. et al. J. Child Psychol. Psychiatry 46, 572‐ 579 (2005). Makela, A. et al. Pediatrics 110, 957‐ 963 (2002). Fombonne, E. et al. J. Austism Dev. Disord. 29. 349‐ 350 (1999) Pediatrics Page 15 xxx 00. #####. ppt 12/7/2020 9: 22: 31 AM

Uchiyama, T. et al. J. Autism Dev. Disord. 37, 210‐ 217 (2007). Madsen, K. M. et al. N. Engl. J. Med. 347, 1477‐ 1482 (2002). De. Stefano, F. et al. Pediatrics 113, 259‐ 266 (2004). Smeeth, L. et al. Lancet 364, 963‐ 969 (2004). Ferriman, A. BMJ 328, 726 (2004). Murch, S. Lancet 363, 821‐ 822 (2004). De. Wilde, S. et al. Br J Gen Pract 51, 226‐ 227 (2001). Farrington, CP. et al. Vaccine 19, 3632‐ 3635 (2001). Peltola, H. et al. Lancet 351, 1327‐ 1328 (1998). Patja, A. et al. Pediatr Infect Dis J 19, 1127‐ 1134 (2000). Fombonne, E. et al. Molecular Psychiatry. 8, 133‐ 134 (2003) Jain A. et al. JAMA. 15, 1534‐ 40 (2015) Uno Y et al. Vaccine. 21, 2511‐ 6 (2015) Pediatrics Page 16 xxx 00. #####. ppt 12/7/2020 9: 22: 31 AM

Looking at all the studies investigating a link between MMR and autism: Institute of Medicine reviewed the body of literature and found that the evidence favors the rejection of a casual relationship between the MMR vaccine and autism. Institute of Medicine. Immunization Safety Review: Vaccines and Autism. Washington, DC: National Academy Press, 2004. http: //www. nap. edu/catalog. php? record_id=10997 Pediatrics Page 17 xxx 00. #####. ppt 12/7/2020 9: 22: 33 AM

Is thimerosal, a mercury derivative, harmful? Pediatrics

What is Thimerosal? • Thimerosal has been used as a preservative in vaccines since 1930; only known risk is hypersensitivity • Thimerosal is 49. 6% by weight ethyl mercury • Ethylmercury has a short half‐life and does not cross the blood brain barrier due to its molecular size Pediatrics Page 19 xxx 00. #####. ppt 12/7/2020 9: 22: 34 AM

"Although the names may sound the same, methylmercury and ethylmercury are very different. An analogy is the difference between methyl alcohol and ethyl alcohol: Methyl alcohol is antifreeze, and ethyl alcohol is a Bud light. " Dr. Ari Brown Immunization Action Coalition. Vaccine Concerns. http: //www. immunize. org/thimerosal/ Pediatrics Page 20 xxx 00. #####. ppt 12/7/2020 9: 22: 34 AM

Evidence that mercury doesn’t cause autism Hviid, et al. JAMA 290, 1763‐ 1766 (2003). Verstraeten, T. et al. Pediatrics 112, 1039‐ 1048 (2003). Heron, J. & Golding J. Pediatrics 114, 577‐ 583 (2004). Andrews, N. et al. Pediatrics 114, 584‐ 591 (2004). Fombonne, E. et al. Pediatrics 118, e 139‐e 150 (2006). Stehr‐Green, P. et al. Am J Prev Med 25, 101‐ 106 (2003) Madsen, KM. et al. Pediatrics 112, 604‐ 606 (2003). Tozzi, AE. et al. Pediatrics 123, 475‐ 482 (2009). Thompson, WW. et al. New England J of Med 357, 1281‐ 1292 (2007) Schechter, R. et al. Arch Gen Psychiatry 65, 19‐ 24 (2008) Gedad, BS. et al. Proc Natl Acad Sci USA 112, 12498‐ 503 (2015) Uno Y et al. Vaccine. 21, 2511‐ 6 (2015) Pediatrics Page 21 xxx 00. #####. ppt 12/7/2020 9: 22: 34 AM

Looking at all the studies between thimerosal and autism: Institute of Medicine reviewed the body of literature and found that the evidence favors rejection of causal relationship between thimerosal‐containing vaccines and autism. Institute of Medicine. Immunization Safety Review: Vaccines and Autism. Washington, DC: National Academy Press, 2004. http: //www. nap. edu/catalog. php? record_id=10997 Pediatrics Page 22 xxx 00. #####. ppt 12/7/2020 9: 22: 35 AM

Do vaccines overwhelm the immune system? Do we give too many too soon? Pediatrics

Our immune systems encounter challenges everyday: “ …an upper respiratory viral infection exposes a child to 4 -10 antigens, and a case of strep throat 25 -50. ” Institute of Medicine. Immunization Safety Review: Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: National Academy Press, 1994. http: //www. nap. edu/catalog. php? record_id=2138 Pediatrics Page 24 xxx 00. #####. ppt 12/7/2020 9: 22: 35 AM

Children are exposed to fewer vaccine antigens today than in the past. . . Offit, P. A. et al. Addressing parents’ concerns: Do multiple vaccines overwhelm or weaken the infant’s immune system? Pediatrics 109, 124‐ 129 (2002) Pediatrics Page 25 xxx 00. #####. ppt 12/7/2020 9: 22: 35 AM

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Do vaccines cause other chronic diseases? Pediatrics

To date, there are no scientific studies validating the link between vaccination and any of the following: • Diabetes • Allergies and Asthma • Sudden Infant Death Syndrome • Multiple Sclerosis (after Hepatitis B vaccine) Pediatrics Institute of Medicine. Immunization Safety Review: Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: National Academy Press, 1994. http: //www. nap. edu/catalog. php? record_id=2138 Page 28 xxx 00. #####. ppt 12/7/2020 9: 22: 38 AM

Evidence that vaccines don’t cause chronic diseases: Kuhnert, et al. Vaccine 30, 2349‐ 2356 (2012). Vennemann, M. et al. Vaccine 25, 336‐ 340 (2007). De. Stefano, F. et al. Pediatrics 108, e 112‐ 117 (2001). Vennemann, M. et al. Vaccine 25, 4875‐ 4879 (2007). De. Stefano, F. et al. Ped Inf Disease 21, 498‐ 504 (2002). Anderson, H. et al. Am J Public Health 91, 1126‐ 1129 (2001) Ascherio, A. et al. New England J of Med 344, 327‐ 332(2001). Confavreux, C. et al. New England J of Med 344, 319‐ 326 (2001). Pediatrics Page 29 xxx 00. #####. ppt 12/7/2020 9: 22: 38 AM

Vaccine Refusal Pediatrics

The Anti‐Vaccine Epidemic quote from Dr. Paul Offit • “Who is choosing not to vaccinate? . . no group…has lower immunization rates…. Malibu and Marina Del Rey, home to some of the wealthiest and most exclusive suburbs in the country. At the Kabbalah Children's Academy in Beverly Hills, 57% of children are unvaccinated. At the Waldorf Early Childhood Center in Santa Monica, it's 68%, …immunization rates that can be found in Chad or South Sudan. But parents in Beverly Hills and Santa Monica see vaccines as unnatural—something that conflicts with their healthy lifestyle… fringe pediatricians willing to cater to their irrational beliefs. These parents are almost uniformly highly educated, but they are making an uneducated choice. It's also a dangerous choice…Because we're unwilling to learn from history, we are starting to relive it. And children are the victims of our ignorance. An ignorance that, ironically, is cloaked in education, wealth and privilege. ” WSJ 9/24/14

Vaccine exemptions across the U. S. http: //www. immunize. org/laws/exemptions_map_july‐ 2015. pdf Pediatrics Page 32 xxx 00. #####. ppt 12/7/2020 9: 22: 39 AM

Percentage children enrolled in kindergarten who have been exempted from one or more vaccines, United States, 2013‐ 14 school year

Characteristics of parents who delay, refuse, or both: • • • 53‐ 62% of non‐Hispanic white 57‐ 72% privately insured 68‐ 82% married 59‐ 67% maternal age >30 86‐ 98% preferred English‐speaking Higher levels of education – 17‐ 24% some college – 30‐ 45% college graduates • Household income – ~50% annual income $30‐ 92 K – ~25‐ 36% annual income >$92 K Smith PJ. et al. Public Health Reports. 126, 135‐ 146 (2011)

Vaccine exemptions in Texas 2003 - TX passes law allowing philosophical exemptions to vaccines for school entry Pediatrics Page 35 xxx 00. #####. ppt 12/7/2020 9: 22: 41 AM

Number of conscientious exemptions by schools Denton Tarrant Travis Texas Department of State Health Services. Harris

Dr. Robert Sears Pediatrics Page 39 xxx 00. #####. ppt 12/7/2020 9: 22: 46 AM

Dr. Bob’s alternative vaccination schedule 2 months DTa. P, Rotavirus 2 years 6 mo Hep B° 3 months* Pc, HIB 2 years 7 mo Hep B, Flu 5 months* Pc, HIB 3 years Hep B 6 months DTa. P, Rotavirus 4 years DTa. P, Polio, Flu† 7 months* Pc, HIB 5 years MMR§, Flu† 9 months Polio, Flu (2 doses) 6 years Chickenpox, Flu 12 months MMR, Polio 7 years Hep A, Flu 15 months Pc, HIB 8 years Hep A, Flu 18 months DTa. P, Polio 9‐ 18 years Flu each year 21 months* Flu 12 years Tdap 2 years Chickenpox 13‐ 14 years HPV (3 doses) 16 years Meningococcal • • • Delays Hep. B until 2. 5 yrs Delays 1 st IPV until 9 mos Delays 1 st dose chickenpox until 2 years and 2 nd dose until 6 yrs Delays Hep. A until 7 yrs No meningococcal 1 st dose at 11 years Pediatrics Page 40 xxx 00. #####. ppt 12/7/2020 9: 22: 48 AM

Dr. Bob’s selective vaccination schedule 2 months DTa. P, Rotavirus 3 months Pc, HIB 4 months DTa. P, Rotavirus 5 months Pc, HIB 6 months DTa. P, Rotavirus 7 months Pc, HIB 15 months Pc, HIB 7 years Tetanus booster 10 years Blood tests for measles, mumps, rubella, chickenpox, and Hep A immunity. Consider vaccinating if not immune. Also consider a 3‐dose polio series if travel to Africa or Asia is a possibility. 12 -14 years HPV (3 doses), Hep B (3 doses). Give separately over these years. Not needed if abstinence is likely. Missing Tdap, MCV 4, and Flu 16 years Meningococcal 17 years Tetanus booster (or Tdap) Missing Hep. B, IPV, Flu Missing Hep. A, DTa. P, IPV, MMR, VAR, Flu Missing DTa. P, IPV, MMR, VAR, Flu Sears RW. The Vaccine Book: Making the Right Decision for Your Child 2 nd Edition. New York, NY: Little, Brown and Company; 2011. Pediatrics Page 41 xxx 00. #####. ppt 12/7/2020 9: 22: 49 AM

Communication Strategies Pediatrics

How you start the conversation matters • Teach your staff (learners) to use presumptive dialogue for all vaccines esp more frequently refused (ex HPV and flu) • Advantage of presumptive language ‐ faster, OK with many, avoids long, potentially problematic discussion ‐ “It’s time for the flu vaccine today. ” ‐ “We need to give Tdap, Meningitis and HPV today. ” • You will likely begin the vaccine-hesitant Opel DJ, et al. Vaccine. 2012; 30: 1269‐ 1275. Pediatrics Page 43 xxx 00. #####. ppt 12/7/2020 9: 22: 50 AM

Participatory dialogue is more likely to cause problems Examples: • “So, have you thought about the flu vaccine this year? ” • “Would you like to talk about the HPV vaccine today? ” • Most vaccine acceptors and hesitant families will become MORE hesitant if this language is used Opel DJ, et al. Vaccine. 2012; 30: 1269‐ 1275. Pediatrics Page 44 xxx 00. #####. ppt 12/7/2020 9: 22: 51 AM

Use the “CASE” model Corroborate About me Science Explain/advise Singer A. Autism Science Foundation. Texas Immunization Summit. www. immunizeusa. org/2010‐summit‐update/ Jacobsen R. et al. The C. A. S. E. approach: guidance for talking to vaccine‐hesitant parents. Minn Medicine: 49‐ 50. Pediatrics Page 45 xxx 00. #####. ppt 12/7/2020 9: 22: 51 AM

So, how do you corroborate? • Carefully! Say, “ I have heard that concern from other parents. ” Say, “ That is a common story that people often share. ” Don’t say, “Oh, I understand why you would think that. ” Don’t say, “You’re right. Many people believe that. ” Don’t accidentally confirm their concern as accurate information. Singer A. Autism Science Foundation. Texas Immunization Summit. www. immunizeusa. org/2010‐summit‐update/ 46 Boom JA, Cunningham RM (2014). Understanding and. Page Managing Vaccine Concerns. Pediatrics xxx 00. #####. ppt 12/7/2020 9: 22: 52 AM

What do I say about me? • Remember: you are the most important influence in a parent’s health care decision • Explain your background, time and effort spent reviewing scientific materials, knowledge gained through study and experience ‐ Say, “I just attended a medical conference and heard an expert, Dr. Flor Muñoz, speak on this very topic. She explained. . . ” Purpose: not to brag, but to reassure the parent of your credibility. Pediatrics Page 47 xxx 00. #####. ppt 12/7/2020 9: 22: 53 AM

What science do I share? • Keep it relevant to the concerns voiced by the parent • Offer information at the educational level of the parent • Stay current • Be confident and clear • Use Vaccine Information Statements and other written and internet resources Pediatrics Page 48 xxx 00. #####. ppt 12/7/2020 9: 22: 53 AM

“I’m worried vaccines will make my baby autistic. My nephew has autism. ” “There are numerous large medical studies examining a link between vaccines and autism. No link has been found. In addition, the United States Institute of Medicine examined all of these studies and has also found no link between vaccine and autism. We know that in some cases, autism is due to a genetic cause. In many other cases, we don’t yet understand the cause. Medical providers and scientists around the world are working to understand the cause and cure for autism. We don’t want one more child to be diagnosed with autism. That said, vaccines have been thoroughly studied and they are not the cause. You can vaccinate your baby confident that vaccines will not cause autism. ” Pediatrics Page 49 xxx 00. #####. ppt 12/7/2020 9: 22: 53 AM

“I’ve heard that the MMR vaccine causes autism. My friends have all delayed giving it to their children until 2 years or later. That is my plan. ” “Unfortunately, there was a doctor in the U. K. that tried to spread this myth, but it’s not true at all. Since then, tons of research has shown that there is no link between vaccines and autism. Unfortunately, that doctor’s misstatements made a lot of parents worry. You can rest assured that the MMR vaccine won’t cause your baby harm. In fact, it is more important now, more than ever, that your child receives it on time. Because so many parents in the U. K and the U. S. haven’t vaccinated, we have children and adults traveling and transmitting the measles virus. So to protect your baby, you need to vaccinate. Pediatrics Page 50 xxx 00. #####. ppt 12/7/2020 9: 22: 54 AM

Tips for explaining/advising • This is your best chance to advise the parent on the best choice for their child • Recognize that the choice will always be theirs, but you are interested in helping them in their efforts • Translate the science into advice • Again, be confident and directive, but not polarizing Pediatrics Page 51 xxx 00. #####. ppt 12/7/2020 9: 22: 54 AM

Watch out for the contingency statement • “We’re running late today, but we’ll come back next week. ” • “I’ll need to go home and talk to the baby’s father. I can’t bother him at work right now. ” • “We’re going on a trip next week. I don’t want there to be any chance that the side effects will ruin our trip. ” Opel D, Feemster K, Omer S et al. Pediatrics, 2014 Pediatrics Page 52 Boom JA, Cunningham RM (2014). Understanding and Managing Vaccine Concerns. xxx 00. #####. ppt 12/7/2020 9: 22: 54 AM

Consider sharing what you do Pediatrics Page 53 xxx 00. #####. ppt 12/7/2020 9: 22: 55 AM

Make it salient http: //www. youtube. com/watch? v=E 1 OI 21 la. A 5 M Pediatrics Page 54 xxx 00. #####. ppt 12/7/2020 9: 22: 56 AM

In this case, it is ethical to persuade! • Explain social norms ‐ ” Parents in my practice like you vaccinate their children every year. ” • Make your discussion salient‐ it is OK to emphasize risk and potential loss, make risks real ‐ “ The influenza virus can kill babies. Did you know that 52 children died in 2012? And 118 children died in 2011? “ • You are an important messenger. Don’t be afraid to make strong recommendations; relay what you do with your own children, use status of people they respect. Pediatrics Page 55 August 30, 2013 / 62(34); ND‐ 466‐ND‐ 479 xxx 00. #####. ppt 12/7/2020 9: 22: 57 AM

A few tips and reminders… • Don’t let this get to you! ‐ Don’t let these parents wear you down ‐ Definitely, don’t let them start convincing you! • Can you be persuasive? ‐ Ethically, the answer is yes! ‐ Why? Because benefits far outweigh risks • How persuasive can you be? ‐ That is up to you • Can you be too persuasive? Pediatrics Page 56 xxx 00. #####. ppt 12/7/2020 9: 22: 57 AM

The AAP recommends: • Avoiding dismissal • Maintaining relationships with vaccine concerned families • Listening carefully and respectfully to parental concerns ‐ Recognize that parents may weigh evidence differently Diekema DS. American Academy of Pediatrics, Committee on Bioethics. Pediatrics. 2005; 115(5): 1428‐ 1431 Pediatrics Page 57 xxx 00. #####. ppt 12/7/2020 9: 22: 58 AM

If all else fails, use the AAP Refusal to Vaccinate form Pediatrics Page 58 xxx 00. #####. ppt 12/7/2020 9: 22: 58 AM

Questions? Julie A. Boom, MD jboom@bcm. edu Pediatrics Page 59 xxx 00. #####. ppt 12/7/2020 9: 23: 00 AM