Addressing Parental Concerns About Vaccine Safety

1. Addressing Parental Concerns About Vaccine Safety David M. Berman, DO, FAAP Division of Pediatric Infectious Diseases All Children’s Hospital, St. Petersburg, Florida

2. Disclosure • I have no financial relationship in regard to the content of this presentation

3. “Vaccines are the perfect storm of fear” -Paul Offit, M.D.

4. Separating fact from fiction

5. Third World Countries “We need vaccines!” http://theconversation.com/for-gm-food-and-vaccinations-the-panic-virus-is-a-deadly-disease-18460 WHO 2012. Photo by David Di Lorenzo/MSF.

6. United States “Gee, I don’t know, do we really need vaccines?”

7. Parental concerns about vaccines • More common in white, higher income, married mothers with college education • Believe their children have low susceptibility to diseases • Believe disease severity is low • Believe vaccine efficacy and safety are low Omer SB et al. NEJM 2009;360:1981-8

8. Parental concerns about vaccines • Five categories of vaccine-hesitant parents • Uninformed but can be educated • Misinformed but correctable • Well-read and open-minded • Convinced and contented • Committed and missionary

9. “Vaccines are not safe: not enough research” • Pre and post-licensure process • Vaccine development • Basic science and clinical trials • FDA and the Advisory Committee Immunization Practices • Stakeholders (multiple medical organizations) • Safety monitoring (VAERS and VSD)

10. “Not at-risk for the Disease” US Outbreaks • Measles:-United States, January 1-November 29, 2014 • 610 cases confirmed from 24 states, 20 outbreaks • Most cases were imported into US • Majority of people were unvaccinated • WHO reports 55,388 suspected cases worldwide (12/2014) • Many of the cases in the US have been associated with imported cases from the Philippines cdc.gov/measles/index.html

11. “Not at-risk for the Disease”US Outbreaks • Mumps:-United States, January 1-November 29,2014 • 1,078 confirmed cases • Outbreaks: Ohio State, Wisconsin-Madison, Illinois- Urbana-Champaign, and Fordham University • Columbus, Ohio • Largest outbreak since the 1940’s • National Hockey League 2014 http://www.cdc.gov/mumps/outbreaks.html http://www.immunize.org/photos/mumps-photos.asp

12. “Not at-risk for the Disease”US Outbreaks • From January 1-August 16, 2014, 17,325 reported cases of pertussis reported to CDC • Thirty percent increase compared to same time period in 2013 • California (2014) • 8749 reported cases • Infants <4 months of age accounted for 62% of hospitalizations http://www.cdc.gov/pertussis/images/pertussis-graph-2014-lg.jpg

13. “Not at-risk for the Disease”US Outbreaks • Outbreak of meningococcal disease at Princeton University and University of California, Santa Barbara • Drexel University student died during the epidemic • Princeton and UCSB students received the serogroup B meningococcal vaccine through an FDA investigational new drug application

14. “Too many vaccines for the immune system to handle” • Smallpox vaccine 200 antigens • All 14 vaccines today have 160 antigens • Infant passes through the birth canal exposed to trillions of bacteria and each bacteria contains 2000-6000 immunologic components. • Children experience 6 to 8 viral infections every year Vaccine Satety and Your Child: Separating Fact from Fiction:2011 AAP Redbook Online Visual Library 2012

15. “Too many vaccines for the immune system to handle” • Cortisol levels measured before and after immunization at 2 and 6 months of age • Study showing that two shots are not more likely to induce cortisol (as a marker for stress) than one shot. Ramsay DS, Lewis S. Child Development 1994;65(5):1491-1502.

16. “Alternative schedules are safer than the recommended CDC schedule” • “Alternative Schedule” (Dr Bob) • Increases time during which children are at-risk for vaccine-preventable diseases • Delaying the measles-mumps-rubella (MMR) vaccine in the second year of life doubles the risk of a seizure occurring after the vaccination. • Spacing vaccines out does not reduce infant stress • Create more anxiety “needle phobia” • More of visits • No benefit • Not science-based medicine Pediatrics 2014;133:e1492–e1499:

17. “I’m concerned about vaccine ingredients: thimerosal” • July 8, 1999: American Academy of Pediatrics and the Public Health Service • Thimerosal was removed from most vaccines despite no adverse effects attributable to thimerosal ever reported. • Autism rates still rose afterwards.

18. “I’m concerned about vaccine ingredients: aluminum” • One of the most abundant metals on Earth; 9% of Earth’s crust • Children and adults typically have between 1-5 ng/ml of aluminum in blood • Aluminum salts are used as vaccine adjuvants • Used for 80 years • Not in live virus vaccines http://www.chop.edu/export/download/pdfs/articles/ vaccine-educationcenter/aluminum.pdf http://www.immunizenevada.org/sites/default/files/NILE/Nevada_AltVax.pdf

19. “I’m concerned about vaccine ingredients: aluminum” • In our diet: typical adults ingest 7-9 mg per day • By 6 months of age, the total amount of aluminum an infant receives will be: • 4 mg from all vaccines • 10 mg from breast milk • 40 mg from infant formula • 120 mg from soy-based formulas http://www.chop.edu/export/download/pdfs/articles/ vaccine-education-center/aluminum.pdf

20. “I’m concerned about vaccine ingredients: formaldehyde” • Small amounts are used to inactivate virus and bacterial toxins • Naturally occurring substance in the human body • Also found in other items we use on a daily basis including, baby shampoo, mascara, carpeting and paper towels

21. “I heard that the MMR vaccine causes autism” • 1998: Wakefield article suggests that MMR vaccine caused intestinal problems and developmental problems in 12 children • Immunization rates drop • Rates of measles and other vaccine-preventable diseases rise Omer SB et al. NEJM 2009;360:1981-8. Wakefield et al. Lancet 1998;351:637-41.

22. “I heard that the MMR vaccine causes autism” • 2004: 10 authors of 1998 paper retract their claims of MMR/autism link • 2010: UK General Medical Council finds that Wakefield misused public funds, failed to disclose payments from an attorney planning an MMR class action lawsuit, failing to get proper informed consent, and falsifying medical records and pathology results • Lancet retracts the 1998 paper

23. “Religious exemption: aborted fetal tissue” • Vatican Pontifical Academy for Life: Moral Reflections on Vaccines Produced from Cells Derived from Aborted Human Foetuses. • “We find, in such a case, a proportional reason, in order to accept the use of these vaccines in the presence of the danger of favoring the spread of the pathological agent, due to the lack of vaccination of children” • “The severity of congenital rubella and the handicaps which it causes justify systematic vaccination against such a sickness” Vatican Statement on Aborted Fetal Vaccines: June 9, 2005

24. “Why should my child receive the HPV vaccine to protect against a sexually transmitted infection?” • HPV infection causes 26,000 cancers each year • United States, 40% of 16 to 17 year olds have already had sex • Five clinical trials 11,770 subjects vaccinated compared to 9600 placebo, no statistical increased risk of any events following vaccination • Since 2006, 57 million doses of HPV have been distributed in the United States • Post-marketing surveillance has found no statistically increased risk of adverse events HPV: You are the Key to Cancer Prevention , 3/2014 J Pediatr Adolesc Gynecol 26 (2013) 243-248

25. “Why should my child receive the HPV vaccine to protect against a sexually transmitted infection?” • Information regarding the HPV vaccine from the media, internet, and social contacts can be very misleading • Provide parents with key information regarding the necessity of the vaccine • Emphasize that the virus not only causes cervical cancer but mucous membrane cancer • HPV can be detected from other body sites and the environment • HPV causes cervical pre-cancer and this can put a woman at risk for problems wit her cervix during pregnancy and lead to preterm delivery HPV: You are the Key to Cancer Prevention , 3/2014 J Pediatr Adolesc Gynecol 26 (2013) 243-248 HPV Vaccine: It's About Cancer Prevention -- Not Sex Paul A. Offit, MD (2014)

26. “Why should my child receive the HPV vaccine to protect against a sexually transmitted infection?” • “Desexualize” the vaccine • Point out that there is no biological or behavioral evidence to support sexual behavior change after HPV vaccine • You may want to tell parents to parents that their child may have already received a vaccine against another virus that is often sexually transmitted, hepatitis B vaccine • Immunity lasts at least 8 years, probably longer based on data from the Hepatitis B vaccine J Pediatr Adolesc Gynecol 26 (2013) 243-248 HPV Vaccine: It's About Cancer Prevention -- Not Sex Paul A. Offit, MD (2014)

27. Always discuss well-known side-effects of vaccines No vaccine is 100% safe Pain and/or swelling at injection site Nodule at injection site (DTaP) Fever (within 24 hours after DTaP, 5-12 days after MMR) Irritability Rash (MMR, varicella) Arthritis (rubella) Thrombocytopenia (MMR) Allergy, Arthus reaction AAP Red Book

28. Summary: Addressing parental concerns -the hard part • Establish honest dialogue and be non-confrontational • Provide strong recommendations • Do not dismiss concerns about vaccine safety, welcome questions • Identify specific parental safety concerns and hesitancy type • Provide factual information in understandable language that addresses the specific concerns or misconceptions the parent has about vaccination. • Anecdotes often work better than scientific data. • Describe cases of vaccine-preventable diseases • Say that you immunized your own child (personal story) HPV: You are the Key to Cancer Prevention , 3/2014 Pediatrics 2011: 127 (S1);S127-133

29. Addressing parental concerns • Be ready to answer the most common questions--many concerns haven’t changed in over 200 years • Remember, it’s acceptable to say you’ll research a question and get back with more information. • Be able to recommend good websites, handouts and books for patients/parents • Be aware of vaccine-critical groups and individuals and become familiar with their websites • It’s worth your time--people still respect the opinion of their healthcare providers

30. Reliable Websites and Mobile App • American Academy of Pediatrics (www2.aap.org/immunization) • Centers for Disease Control and Prevention (www.cdc.gov/vaccines/conversations) • Children’s Hospital of Philadelphia (vaccine.chop.edu/mobileapp and www.chop.edu/service/vaccine-education-center) • Immunization Action Coalition (www.immunize.org) • Every Child by Two (www.ecbt.org) • Meningitis Angels (www.meningitis-angels.org) • National Network for Immunization Information (immunizationinfo.org) • Shot at Life (shot@life.org and shotatlife.org/mobile) • Parents of Kids with Infectious Disease (www.pkids.org)

31. List of Vaccine Critical Websites (Sites for Parents to Avoid) • National Vaccine Information Center (www.nvic.org) • Dr Bob Sears (www.askdrsears.com/topics/health-concerns/vaccines) • Dr Joseph Mercola (vaccines.mercola.com) • Age of Autism (ageofautism.com/vaccines) • Generation Rescue (www.generationrescue.org/resources/vaccination) • Natural News (www.naturalnews.com/vaccinations.html) • Safe Minds (safeminds.org/mercury/vaccines-and-autism.html)

32. Recommended Books • Offit PA, Moser, CA. Vaccines and Your Child: What Every Parent Should Know. New York, NY: Columbia University Press; 2011 • Cunningham RM, Boom, JA. Vaccine-Preventable Disease: The Forgotten Story. Texas Children’s Hospital; 2014 • Chatterjee A. Vaccinophobia and Vaccine Controversies of the 21st Century. New York, NY: Springer Science and Business Media; 2013 • CDC: Guide to Vaccine Contraindications and Precautions (www.cdc.gov/vaccines/recs/vac.../contraindications-guide-508.pdf )

33. Global Immunization is Effective!