Immunizations: Maintaining One of the Greatest Public Health Achievements Not Fake News

1. Immunizations: Maintaining One of the Greatest Public Health Achievements Not Fake News Denise H. Benkel, MD, MPH Medical Specialist Bureau of Immunization NYC Department of Health and Mental Hygiene dbenkel@health.nyc.gov February 26, 2019

2. Ten Great Public Health Achievements • United States, 1900-1999 • Vaccination • Motor-vehicle safety • Safer workplaces • Control of infectious diseases • Decline in deaths from coronary heart disease and stroke • Safer and healthier foods • Healthier mothers and babies • Family planning • Fluoridation of drinking water • Recognition of tobacco use as health hazard

3. Comparison of 20th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases (1) †Source: JAMA. 2007;298(18):2155-2163 † † Source: Centers for Disease Control and Prevention. [Summary of Notifiable Infectious Diseases and Conditions, 2015]. Published August 11, 2017 for MMWR Morb Mortal Wkly Rep 2015;64(No.53):1-146

4. Comparison of 20th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases (2) Pre-vaccine Era Annual Morbidity† 2015 Cases* % reduction Hepatitis A 117,333 1,390 99% Hepatitis B (acute) 66,232 3,370 95% H. influenzae b (invasive)** 20,000 29 >99.8% Pneumococcus (invasive)** 63,067 1,177 98.1% Varicella 4,085,120 9,789 99.8% Influenza N/A N/A (130***) --- Meningococcus (invasive) 2,183 372 83% †Source: JAMA. 2007;298(18):2155-2163 *Source: CDC. MMWR January 8, 2016;64(52); ND-923-ND-940 (provisional MMWR week 52 data) **Among children < 5 years of age ***Pediatric deaths; as of January 8, 2016 six influenza-associated pediatric deaths reported in 2015-16 season

5. Slide from Perspectives on Vaccine Hesitancy by Gary S. Marshall, M.D., presented as webinar by National AHEC Organization, 1-10-18

6. ImmunizationsRecommendations vs. School Requirements • Recommended Schedule • Developed nationally by the Advisory Committee on Immunization Practices (ACIP) • Defines national standard of practice • Endorsed by the AAP, AAFP, ACOG • New York (NY) School Requirements for pre-K and K-12 • Immunizations are required to register for school and to remain in school (pre-K, K-12) • Same requirements for all public and private schools throughout NYS (NYC and non-NYC) • Defined by NYS PHL§2164 and City Health Code

7. ACIP Recommended Childhood and Adolescent Immunization Schedule, 2019* * Available at: www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html

8. ACIP Catch-Up Schedule, 2019

9. ACIP Medical Indications Schedule, 2019

10. ACIP Schedule, 2019 - Notes, page 1

11. ACIP Schedule, 2019 - Notes, page 2

12. ACIP Schedule, 2019 - Notes, page 3

13. ACIP Schedule, 2019 - Notes, page 4

14. Slide from Perspectives on Vaccine Hesitancy by Gary S. Marshall, MD, presented as webinar by National AHEC Organization, 1-10-18

15. Vaccine Myths (Fake News)

17. Rare disease/Vaccine Side Effects • Diseases are prevalent elsewhere • Measles in Europe • Polio still endemic in Pakistan & Afghanistan • Only a plane ride away • Outbreaks still occur in U.S. • Jan-April 2014: Mumps outbreak in the Bronx • 10 infants died of pertussis in California in 2010 • 2015: Disneyland measles outbreak • June-Nov 2015: Mumps outbreak in Rockaways • Oct 2014-April 2016: Pertussis in Brooklyn • March-August 2016: Chickenpox in Brooklyn • Current outbreak of measles in Brooklyn: 90 cases

18. Disneyland Outbreak • Low vaccination rates • 93% statewide UTD • 70% of children in counties with vaccination rate below 95%; 36% below 90% • After outbreak, Senate Bill 277 tightened school immunization requirements • Conditionally-enrolled needed plan • No more personal-belief exemptions • Law changed behavior • 97% of children live in counties with vaccination rate above 95%

19. Rare diseases/Vaccine Side Effects (2) • Diseases not common because of vaccines • Concentrate on vaccine-preventable diseases’ complications, not vaccine risks • Measles –risk of acute encephalitis: 1/1,000 • MMR vaccine – risk of acute disseminated encephalomyelitis: 1/1,000,000 • VAERS passive surveillance not accurate profile of side effects; coincidental not causal • Vaccines are tested in large numbers of children for longer periods of time than drugs

20. “Overwhelm” the Immune System *Abbas Cellular and Molecular Immunology †Offitt Pediatrics 2002 • Theoretical capacity allows for 109 to 1011 different antibody specificities* • Far fewer antigens in the vaccine schedule now than 50-60 years ago • 1950’s: 3200 antigens, 5 diseases • 2014: 315 antigens, 14 diseases • Antigen load reduced to 10% of the previous amount, with protection against almost three times as many diseases • Children respond to multiple vaccines given at the same time in a manner similar to individual vaccines.†

21. “Overwhelm” the Immune System (2) • Advocates want an “alternative schedule” to allow for “recovery” between vaccinations • Why not recommended • Infant is susceptible to the vaccine-preventable diseases for a longer period of time • Increases the possibility of exposure while they are still vulnerable • Increases the number of office visits to the doctor for vaccine administration, with associated exposure to illnesses, costs, and missed opportunities to vaccinate • Increases quantity of shots since alternative schedule often does not allow combination shots • May create a traumatic aversion to future doctor visits

22. “More vaccinated get sick” • Since more kids are vaccinated, more will be sick even though percentage-wise much lower • 1985-1992: Nationwide study • Exemptors 35 times as likely to contract measles than vaccinated children*. • 1987-1998: Colorado • Exemptors 22 times as likely to have had measles and almost six times as likely to have had pertussis than vaccinated children† • Vaccinated ill person usually less sick, for shorter amount of time *Salmon JAMA 1999; †Feiken JAMA 2000

23. “Improved hygiene more important” • Germ theory- introduced mid-1800’s • Accepted into practice by the turn of the century • Mid-1900s: diphtheria, measles, mumps, tetanus, pertussis, polio, and rubella rates took drastic drops • Haemophilusinfluenzae type b and pneumococcal disease drops confirm the fact that “good hygiene and nutrition” could not be the cause of the decrease in numbers, as their decrease occurred in the late 1990s and early 2000’s, respectively • Polio: improved hygiene and clean water were main CAUSES of outbreaks

24. Steep Drops in Diseases Coincided with Introduction of Disease-Specific Vaccines

25. “MMR causes autism” • Study of 530,000 Danish children found no evidence of an increased risk of autism or ASD in vaccinated children* • Study in Japan found that autism rates continued to increase after the withdrawal of the MMR vaccine† • Independent IOM concluded in 2004 no link • What about separating MMR into three separate vaccines? • No benefit • Would result in missed opportunities *Madsen NEJM 2002; †Honda J of Ch Psych & Psych 2005

26. “MMR causes autism” (2) The Wakefield study • Original article not only bad science, was actually elaborate fraud • Wakefield misrepresented or altered the medical histories of all 12 patients whose cases formed the basis for the 1998 study • 10 of 12 Wakefield’s co-authors retracted the article • Lancet eventually retracted the article • Wakefield found guilty of serious professional misconduct over the way he carried out his research, and lost his British medical license and academic appointments

27. “Thimerosal causes autism” • Methylmercury • More easily binds to tissues • Remains there a long time • Builds up in fish • At high levels, is known to be toxic • Federal standards for mercury based on this mercury • Ethylmercury • Is the type found in thimerosal • Does not pass the blood-brain barrier and enter the CNS • Is broken down and excreted much more rapidly • Much less likely to accumulate in body and cause harm

28. “Thimerosal causes autism” (2) 1999: As a precaution, FDA, CDC, AAP and vaccine manufacturers agreed to reduce or eliminate thimerosal from vaccines 2001: Except for influenza, thimerosal is removed from or reduced in all vaccines for children < 6 2004: The IOM concludes that studies “consistently provided evidence of no association between thimerosal-containing vaccines and autism” Currently: Autism rates have continued to rise despite thimerosal removal Autism: Genetic and environmental causes (but not vaccinations)

29. “Aluminum in Vaccines is Unsafe” • Is an adjuvant that improves vaccine potency. • Is the most common metal in our earth’s crust and is everywhere • Naturally present in water, soil, air • Fruits, vegetables, nuts and flour have it • By six months exposed to 4-6 mg from vaccines • Exposed to 10 mg from breast milk, 40 if on cow’s milk formula, 120 if soy

30. “Vaccines Cause SIDS” • Infants begin primary course of vaccinations from 6 weeks to 4 months of age. • Peak age for SIDS is 2 to 4 months of age. • IOM report in 2003 “did not find enough evidence to show vaccines cause SIDS” • Study using Vaccine Safety Datalink data found no association between immunization and death in young children • Studies looking at VAERS data showed no association

31. “The HPV vaccine is unsafe, leading to fainting and even death” • Tested for 7 years in 30,000 women • 40 million doses have been administered • In a study of over 600,000 HPV4 doses, no significant increased risk for any adverse events1 • 30 other PubMed studies • No common pattern that might suggest these deaths were caused by the vaccine2 • In cases where there was an autopsy, cause of death could be explained by other factors3 1Gee Vaccine 2011; 2FAQs about HPV Vaccine Safety, CDC 3Slade JAMA 2009

32. “The HPV vaccine encourages sexual activity” • Retrospective cohort study of 1398 girls (493 HPV vaccine-exposed; 905 vaccine-unexposed). • Looked at risk of pregnancy, STD testing or diagnosis or contraceptive counseling • HPV vaccination in the recommended ages was not associated with increased sexual activity-related outcome rates* • Parents should be told to consider this a “cervical cancer vaccine” (adolescents should be told it does not offer protection against HIV or STDs) *Bednarczyk Peds 2012

33. “Big Pharma and Doctors Promote Vaccine Because of Profits” • Vaccines not a great profit-maker • Years of research; many never make it to market • Prevnar 13 and Gardasil only major profit-makers • “Alternative” therapies promoted on sites that talk about “Big Pharma” are also profit-makers • Profits don’t necessarily negate value • VFC and reimbursement issues limit doctors’ profits. *

34. Paul Offit, MD Director, Vaccine Education Center at CHOP "How to Communicate Science to the Public or Die Trying“ "We live in a society where scientific illiteracy has devolved to scientific denialism. People simply declare their own truths: vaccines cause autism, climate change is a hoax, or creationism and evolution are equally valid hypotheses. As a consequence, science is losing its place as a source of truth. Now, more than ever before, it is important for scientists, clinicians, academics, and public health officials to stand up for science.

35. How to Handle Resistance • Engage the patient respectfully and fully in the discussion • Use empathy, collaboration, evocation and support for autonomy • Use open-ended questions and reflections • Use behavior-change principles like emphasizing social norms, pivoting from debunking myths to focus on the disease that is prevented • Make a clear, strong, and personalized recommendation

36. Technical Information About Immunizations: References CDC www.cdc.gov/vaccines/ Immunization Action Coalition www.immunize.org/

37. Parental Concern About Immunizations: References CDC www.cdc.gov/vaccinesafety www.cdc.gov/vaccines/parents www.cdc.gov/vaccines/conversations Immunization Action Coalition www.immunize.org/concerns Children’s Hospital of Philadelphia www.chop.edu/service/vaccine-education-center https://www.chop.edu/pages/vaccine-safety-and-autism-resources Families Fighting Flu www.familiesfightingflu.org Voices For Vaccines www.voicesforvaccines.org

38. Parental Concern About Immunizations: HPV References • CDC’s “Tips and Time-savers for Talking with Parents about HPV Vaccine” https://www.cdc.gov/hpv/hcp/for-hcp-tipsheet-hpv.pdf • IAC’s “Human Papillomavirus HPV: A Parent’s Guide to Preteen and Teen HPV Vaccination” www.immunize.org/catg.d/p4250.pdf

39. Anti-Vaccine Sites • New York Coalition for Vaccination Choice • Coalition for Informed Choice • National Vaccine Information Center (NVIC) • New Yorkers for Vaccination Information and Choice • Autism Action Network • Vaccination Liberation • My Kids, My Choice

40. Thank you. Denise H. Benkel, MD, MPH dbenkel@health.nyc.gov