Old Tales Julio A. Rebolledo PharmD, BCPS, BC-ADM, AE-C Assistant Professor, Pharmacy Practice Midwestern University Chicago College of Pharmacy Conflicts of Interest

• I have no conflicts of interest to disclose Learning Objectives for Pharmacists and Technicians 1. Explain common vaccine misconceptions among parents, patients and healthcare providers 2. Examine the evidence-based information about common vaccine misconceptions 3. Apply common strategies to help healthcare providers, patients and parents make informed decisions about Role of

• Prevent and its complications • Pneumonia • • Cancer • Death • Optimize public health • Decrease health care costs • A 5% reduction in MMR vaccination among kids 2-11 years old would increase the public sector cost by an additional $2.1 million

https://www.cdc.gov/vaccinesafety/concerns/multiple-vaccines-.html JAMA Pediatr. 2017;171(9):887-892 JAMA. 2016;315(11):1149-1158 Vaccination rates (data from 2016)

• Vaccinated children aged 19-35 months: • , , Pertussis (4+ doses DTP, DT, or DTaP): 83.4% • Polio (3+ doses): 91.9% • Measles, Mumps, Rubella (MMR) (1+ doses): 91.1% • type b (Hib) (primary series + booster dose): 81.8% • Hepatitis B (Hep B) (3+ doses): 90.5% • Chickenpox (Varicella) (1+ doses): 90.6% • Pneumococcal conjugate vaccine (PCV) (4+ doses): 81.8%

• Combined 7-vaccine series: 70.7% https://www.cdc.gov/measles/cases-outbreaks.htm Vaccine refusal

• Continued to increase for the past 20 years • Resulted in outbreaks, deaths and increase in healthcare costs • measles and pertussis • Nonmedical exemptions are common among unvaccinated children • exemptions from school requirements • Unvaccinated children can infect others: • children too young to be vaccinated • children with inadequate may get infected • immunocompromised

N Engl J Med. 2009;360(19):1981-88. JAMA. 2016;315(11):1149-48. Pediatrics. 2018;142(5):e20181051. https://www.cdc.gov/flu/weekly/index.htm#MS2 https://www.cdc.gov/measles/cases-outbreaks.html

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Social media Perceived risks/benefits Personal beliefs Insurance Cultural beliefs Bias; confirmation, Religious beliefs omission, availability Need for additional Schedules heuristic.. Access to care information Vaccine safety Cost Policies Politics Awareness/knowledge Provider trust/knowledge Celebrities Mode of delivery Health literacy Past experiences Industry Social trust Geographical location Patient case

An 11-year old girl presents to the clinic for a well-child check. The girl is due for the human papilloma virus (HPV) vaccines series, but her mother is not convinced that she needs it and is concerned with the safety and effectiveness of this new vaccine.

How would you approach this case? Misconceptions among parents and patients Tale # 1 Safety

"Vaccines aren't safe" Which of the following childhood vaccines contain thimerosal ?

A. Rotavirus and IPV vaccine B. Varicella and Dtap vaccine C. MMR and pneumococcal conjugate vaccine D. No childhood vaccine contains thimerosal Vaccine safety

• Vaccine components are harmful and may cause autism, brain damage, behavioral problems, and severe reactions • Thimerosal • Causes autism • Aluminum • Causes brain damage and bone disease • Gelatin • Causes allergic reactions • Vaccines may cause febrile seizures

Vaccine. 2015;33(48):6736-6744 http://www.immunize.org/talking-about-vaccines/adjuvants.asp https://www.cdc.gov/vaccinesafety/concerns/thimerosal/index.html Thimerosal (Ethylmercury)- Autism

• Mercury is a metal found naturally in the environment • Used as a preservative to prevent contamination in multi-dose vaccine vials • Research does not show a connection between thimerosal and autism • Thimerosal removed from all childhood vaccines in the US in 2001 • Even after the removal of thimerosal autism rates continue to increase • No childhood vaccines in the US contain thimerosal, except: • Influenza vaccines (multi-dose vials) https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf https://www.publichealth.org/public-awareness/understanding-vaccines/goes-vaccine/ Manuscript retraction

Lancet. 1998:351;637-641 Aluminum-brain damage/bone disease

• Used as an adjuvant in vaccines • Makes vaccines more effective; increases immune response • Fewer doses of vaccine are needed to build immunity • It is naturally present in water, foods (fruits vegetables), breast milk and baby formula • Adults ingest 7 to 9 milligrams of aluminum per day • The amount of aluminum in vaccines is negligible (1.1-4mg) • Patients with renal failure may be affected if given in high amounts • Buffered aspirin (10-20 mg/tab) and antacids (104-208 mg/tab)

https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-ingredients/aluminum#.VmdqduMrKL4 Gelatin- allergic reactions

• It is formed by boiling skin or connective tissue • Used as a preservative and stabilizer, keeping vaccines effective under heat or cold and for the duration of their shelf life • May cause an allergic reaction • about 1 case per 2 million injections • MMR vaccine on the high end, containing 14.5 mg per dose, and the DTaP on the low end, with only 0.0015 mg. • Children with a history of gelatin allergies can seek alternatives or exemptions

https://www.publichealth.org/public-awareness/understanding-vaccines/goes-vaccine/

https://en.wikipedia.org/wiki/Gummy_bear Febrile seizures

• Seizures caused by fever of 102 F (38.9 C) or higher, • Do not cause permanent damage • Febrile seizures can be caused by infections or other illnesses • Cold, flu, measles, ear infections... • Five percent of children will have a febrile seizure some time in their life • Most common between 14-18 months of age • Small increased risk after MMR or MMRV vaccines • Risk slightly higher with MMRV combination (1 additional seizure/ 2300 doses) • Usually 5 to 12 days after the first dose • Usually 22% with MMRV and 15% with separate injections

• Increased risk not seen when MMRV used as second dose Pediatrics. 2010;126:e1-8 https://www.cdc.gov/vaccinesafety/concerns/febrile-seizures.html Febrile seizures

• There is a small increased risk when inactivated influenza is given with PCV13 or Dtap vaccines • Risk for febrile seizures increased during the 24 hours after vaccination • Flu shot was not associated with increased risk of febrile seizures when given on a different day from these two vaccines • Risk is at most 30 febrile seizures in 100,000 children vaccinated • ACIP continues to encourage vaccination according to schedule • Vaccines can also help prevent febrile seizures!

https://www.cdc.gov/vaccinesafety/concerns/febrile-seizures.html Pediatrics. 2010;126:e1-8 Other vaccine safety concerns

• Analysis of >1000 research articles concluded: • "very few problems are caused by or clearly associated with vaccines" • Evidence favors rejection of a causal relationship: • MMR vaccine and type 1 diabetes • DTaP (tetanus) vaccine and type 1 diabetes • Inactivated and Bell’s palsy (weakness of the facial nerve) • Inactivated influenza vaccine and exacerbation of asthma or reactive airway disease episodes in children and adults

https://www.nap.edu/read/13164/chapter/1 Tale # 2 Vaccine schedules "Too many vaccines given at the same time" True or False

Administering multiple vaccines at the same time may overload the Vaccine schedules

"My child is getting too many vaccines at the same time and this can cause more side effects and overload the immune system"

https://www.cdc.gov/vaccinesafety/concerns/multiple-vaccines-immunity.html https://www.nap.edu/read/2138/chapter/5#62 Vaccine schedules

• Number of vaccines against preventable diseases has increased with the years • CDC recommends vaccines against 14 infectious diseases before the age of two • Child immune system can handle more than that • Babies are exposed daily to hundreds of bacteria and viruses • nose, hands, food, objects.. • Cold = Child is exposed to up to 10 • Strep throat = Child is exposed to about 25-50 antigens • Each vaccine in the childhood vaccination has between 1-69 antigens • Child that receives all scheduled vaccines by the age of 2 may get up to 320 antigens! https://www.cdc.gov/vaccinesafety/concerns/multiple-vaccines-immunity.html https://www.nap.edu/read/2138/chapter/5#62 Vaccine schedules

• Recommended schedule ensures children get the best protection during the many different stages in growth and development • There are multiple vaccine combinations available • MMR-V, DTap-IPV, DTap-Hib-IPV, DTap-Hib-IPV-HepB • Giving multiple means fewer clinic visits • Saves you time, money and less trauma for the child • Parental vaccine delay or refusal leads to an increased risk of vaccine- preventable disease in children

JAMA. 2016;315(11):1149-1158 https://www.who.int/vaccine_safety/initiative/detection/immunization_misconceptions/en/index6.html Summary

• Safety • Thimerosal has been removed from all childhood vaccines • No reputable scientific studies have found an association between thimerosal or other components in • Risk of febrile seizures is increased when MMRV is given as a combination • Increased risk not seen when MMRV (combination) used as second dose • Vaccine schedule • Recommended schedule ensures children get the best protection during the many different stages in growth and development • Parental vaccine delay or refusal leads to an increased risk of vaccine- preventable disease in children Social media

Image removed due to copyright. Refer to citation: https://www.dailymail.co.uk/tvshowbiz/article- 3326505/Oprah-Winfrey-reveals-led-parodied- audience-car-giveaway.html https://www.dailymail.co.uk/tvshowbiz/article-3326505/Oprah-Winfrey-reveals-led-parodied-audience-car-giveaway.html Social media Social media

• Misinformation—"both deliberately promoted and accidentally shared—is perhaps an inevitable part of the world in which we live, but it is not a new problem. People likely have lied to one another for roughly as long as verbal communication has existed. Deceiving others can offer an apparent opportunity to gain strategic advantage, to motivate others to action, or even to protect interpersonal bonds. Moreover, people inadvertently have been sharing inaccurate information with one another for thousands of years"

https://www.americanscientist.org Social media

• Potential adverse effects of misinformation: • amplify the vaccine debate • decrease vaccination coverage • increase in preventable diseases • contributes to outbreaks in some communities • Celebrity health endorsements can • amplify harmful messages • or help promote healthy behaviors

JAMA. 2018; 320(23):2417-18 Am Sci. 2017;105(6):372-375. Am J Public Health. 2018;108:1378–1384 Social media

• Web-based social media interventions can positively influence parental vaccine behavior

• In addition to routine well-child information

• And when presented to parents before child is born • During pregnancy

Pediatrics. 2017;40(6):e20171117 Summary

• Social media • Celebrities' endorsements and social media can have a positive or negative effect • It can positively influence vaccine behavior during pregnancy Misconceptions among healthcare providers Simultaneous vaccine administration "It's complicated" Which of the following statements is correct?

A. Most live and inactivated vaccines can be administered on the same visit as all other vaccines B. Administration of two or more live vaccines should be separated for at least 2 weeks C. Simultaneous administration of inactivated vaccines may result in decreased antibody response D. Administering multiple vaccines on the same visit increases adverse reactions Figuring out which vaccine can be given at a single visit is complicated

• Most vaccines can be given simultaneously • Two exemptions • PPSV23 and PCV13

• In patients with anatomic or functional asplenia, if Menactra (MenACYW) brand is used, PCV13 should be given first followed by Menactra 4 weeks later

https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html#ref-82 Spacing of live and inactivated antigens (vaccines)

Antigen combination Recommended minimum interval between doses Two or more inactivated May be administered simultaneously or at any interval between doses Inactivated and live May be administered simultaneously or at any interval between doses Two or more live injectable 28 days minimum interval, if not administered simultaneously

https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html#ref-82 Administering vaccines during pregnancy and breastfeeding Which of the following statements is incorrect? A. Live vaccines should not be administered to women known to be pregnant B. Live and inactivated vaccines may be given to all breastfeeding women C. In general, inactivated vaccines may be administered to pregnant women for whom they are indicated D. Human papilloma virus vaccine (HPV) may be administered during pregnancy Vaccines during pregnancy

• Pregnant women should not get vaccinated-False

• Influenza and Tdap are recommended during pregnancy

• Other vaccines may be administered depending on the risk factors

• Pregnant women should not receive LIVE vaccines

• HPV should not be administered BMJ 2019;366:l4454 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html#ref-82 Vaccines during breastfeeding

• Breastfeeding women should not receive vaccines- False

• Live and inactivated vaccines may be given to all breastfeeding women • Exemption-

• Other • Vaccines should not be given to people who are sick- False • Mild disease with or without fever is not a contraindication BMJ 2019;366:l4454 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html#ref-82 Recent medical graduates may be more skeptical of vaccines than older providers • Survey in 2005

• Recent graduates believe that vaccines are less efficacious and less safe compared to graduates from a previous 5-year period

• Believe that vaccines do more harm than good

Vaccine. 2013;1(2):154-166 Summary- Provider's misconceptions

• Most live and inactivated vaccines can be administered simultaneously • Live and inactivated vaccines may be given to all breastfeeding women • Most inactivated vaccines may be administered to pregnant women for whom they are indicated • Mild disease with or without fever is not a contraindication • Recent medical graduates may be more skeptical of vaccines than older providers Strategies to help healthcare providers, patients and parents make informed decisions about vaccination Regarding vaccine acceptance, which of the following statements is incorrect? A. If providers continue to pursue their original recommendation after encountering parental resistance, many parents eventually agree B. Fewer parents voice resistance to vaccines when a physician uses a participatory approach to vaccinations C. Fewer parents will voice resistance to vaccines when a physician uses a presumptive approach to vaccinations D. Staying informed and anticipating anti-vaccine behavior at the pharmacy may increase vaccine acceptance "There is no vaccine against resistance or refusals that are rooted in social-cultural, religious and political contexts. No supply chain can overcome issues of gender-based decision-making in households. Medical approaches alone cannot address certain community concerns"

Bull World Health Organ 2009;87:624–630 Addressing vaccine hesitancy

• Be proactive • Actively correct inaccurate stories • Discuss- at the office/pharmacy (it is easier) • Social media • Challenge celebrities • Do not dismiss any news story • Be consistent even after encountering parental resistance • if providers continue to pursue their original recommendation after encountering parental resistance, many parents eventually agree to it

Pediatrics. 2013;132:1037–1046 JAMA. 2019;321(22):2159-60 The type of communication used by the provider is important • How providers initiate and pursue vaccine recommendations is associated with parental vaccine acceptance • Presumptive communication • "It's time for little Johnny to get vaccinated" • "we have to do some shots today" • Participatory communication • "should little Johnny get vaccinated today?" • "What do you want to do about shots • Parents are more resistant when a participatory approach is used

Pediatrics. 2017;171 Pediatrics. 2013;132:1037–1046 Addressing vaccine hesitancy in the pharmacy

• Stay informed and anticipate anti-vaccine behavior at the pharmacy • Plan your response in advance • Understanding the community you serve • Identify and deliver tailored and persuasive message • Identify underlying issues and resolve them • Knowledge is important but not enough • "Social trust" • Where do they get their information from? • Consider a variety of methods to deliver your message • Social media, videos, letters, news... J A Pharm Assoc. 2016;56:209-210 Parents and patients evaluate the message and the person delivering the message • Acknowledge their concerns • Current beliefs, motivation • Find common ground • Be respectful • Inform them of where you get your information from • Research, conferences, websites... • Explain and advise • Use science and your experience • Keep it simple

http://www.immunize.org/talking-about-vaccines/responding-to-parents.asp O'Connor C and Weatherrall JO. The missinformation age: How false beliefs spread. Yale University Press. 2019 Summary

• Most beliefs we have come from others • Bad information spreads quickly (vaccines cause autism) • People trust those who share same or similar values and ideas • Emotions are more powerful than facts • Data ignores motives, hopes, fears and desires • No data can convince a hesitant parent • "Vaccines save lives"… therefore you should vaccinate your child. Not enough. • Know your community • Know where to get your information • Use different communication tools to deliver your message Sharot T. The influential mind: What the brain reveals about our power to change others. New York. 2017. J A Pharm Assoc. 2016;56:209-210 Resources

• Free Apps • CDC vaccine schedules; Shots , My immunizations, PneumoRecs/VaxAdvisor • Updated vaccine schedules, the pink book, morbidity and mortality weekly report (MMWR) patient, parents and provider resources • www.cdc.gov • General vaccine information • www.publichealth.org • VIS, standing orders templates, handouts, clinic tools, ask the experts.. • www.immunize.org • Parent vaccine information • www.chop.edu • www.aap.org • National academy press; vaccine resources • www.nap.edu • The World Health Organization; global vaccine information and news • www.who.int Questions?