What s New In Pediatric Vaccines? and Addressing Vaccine Hesitancy

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1 What s New In Pediatric Vaccines? and Addressing Vaccine Hesitancy Kathryn M. Edwards MD Sarah H. Sell and Cornelius Vanderbilt Chair Professor of Pediatrics Vanderbilt University Medical Center Disclosures I have no financial relationship with the manufacturer of any commercial product discussed in this activity All recommendations are in accordance with recommendations from the AAP and ACIP 1

2 Objectives Discuss changes in the immunization schedule for healthy and immunocompromised children Review data on new live influenza vaccine What are the major reasons parents decline vaccines? Health care providers play major role in promoting vaccines Review approaches that have been associated with increased vaccine acceptance. 2

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6 US ACIP Influenza Vaccine Recommendations Historically recommended for all high-risk children 6 months In 2005 recommended for all children aged 6-23 months to prevent hospitalizations and deaths In 2006 recommended for all children aged months to prevent outpatient visits and indirect costs In 2008 recommended for all persons 6 months In 2014 preferential recommendation for LAIV for healthy children (2-17 years of age) since LAIV consistently more effective than trivalent IIV in this population In 2015 preferential recommendation for LAIV removed LAIV4 not recommended in the US for and seasons LAIV4 will be available for the season 6

7 Vaccine Shedding was Assessed to Determine if the Virus was Growing in the Nose Presented at the ACIP February 2018 The New LAIV Strain Grew Better and for Longer than the Old Strain Presented at the ACIP February

8 Antibody Titers were Higher with the New Strain than the Old Strain Presented at the ACIP February 2018 Antibody Titers were similar to other Successful LAIV Strains from Past Presented at the ACIP February

9 Other Vaccine Strains in LAIV Also Generate High Antibody Presented at the ACIP February 2018 Virus Shedding Must Occur or Vaccine will not be approved. Presented at the ACIP February

10 Structure of Shingrix Vaccine 10

11 Vaccine Hesitancy 11

12 Comparison of Maximum and Current Reported Vaccine-Preventable Diseases, United States Disease Pre-vaccine Era* 2000 % change Diphtheria 31, Measles 390, Mumps 21, Pertussis 117,998 7, Polio (wild) 4, Rubella 9, Congenital Rubella 19, Tetanus 1, Hib Disease 24, Total 566,706 8, * Maximum cases reported in pre-vaccine era + Estimated because no national reporting existed in the prevaccine era Historical Perspective 12

13 Evolution of a Vaccine Program 1 Prevaccine Increasing Coverage Loss of Confidence Resumption of Confidence Eradication Disease Vaccinations Stopped Incidence Vaccine Coverage Outbreak Adverse Events Eradication Maturity Vaccine hesitancy Definition of WHO Sage Group 13

14 Vaccine concerns are not new, but have increased in the past decade Concerns about adolescent/adult vaccines even more common 14

15 Increased frequency of requests for alternative schedule Refusal rates differ for various vaccines 15

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18 The Vaccine Evaluation Process 18

19 How Many Safety Data are Enough? SAMPLE SIZES NEEDED TO DETECT RARE EVENTS Rate Sample Size 1 / 5,000 1 / 10,000 1 / 100,000 19,200 38, ,250 Rate Sample Size % of Birth Cohort # Potentially Affected 0.1% vs 0.2% 50, % 4, % vs 0.3% 17, % 8, % vs 0.02% 500, % % vs 0.03% 175, % 800 Adapted from Ellenberg 1997, Davis

20 Currently available rotavirus vaccines Rotarix (GSK) RotaTeq (Merck) Origin Human monovalent Bovine pentavalent Strain G1, P(8) G1, G2, G3, G4, P(8) Vaccine course 2 doses - oral 3 doses - oral Presentation Lyophilized, Liquid reconstituted Phase III trials n=63,225 n=70,301 Efficacy vs rotavirus g-e 85% - 100% vs severe 98% vs severe Efficacy vs allcause severe g-e 42-70% hospitalization for severe g-e 59% hospitalization for diarrhea of any cause Intussusception No association No association 20

21 The Impact of Nonmedical Exemptions 21

22 AAP Recommendations for Nonmedical Exemptions 22

23 AAP Recommendations for Nonmedical Exemptions Countering Vaccine Hesitancy 23

24 Physicians have different methods to deal with parental concerns 24

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26 MMWR July 14, 2017 MMWR July 14,

27 Younger Physicians More Concerned About Vaccine Safety 27

28 Vaccine Safety, Necessity of Vaccines, And Freedom of Choice are Major Concerns 28

29 Communication Highlights:AAP Vaccines are safe and effective, and serious disease can occur if your child and family are not immunized. Vaccine-hesitant individuals are a heterogeneous group and their individual concerns should be respected and addressed. Vaccine are tested thoroughly prior to licensure and vaccine safety assessment networks exist to monitor vaccine safety after licensure. Nonmedical vaccine exemptions increase rates of unvaccinated children. Unvaccinated children put vaccinated children and medically exempt children who live in that same area at risk. 29

30 Communication Highlights:AAP Pediatricians and other health care providers play a major role in educating parents about the safety and effectiveness of vaccines. Strong provider commitment to vaccination can influence hesitant or resistant parents. Personalizing vaccine acceptance is often an effective approach. The majority of parents accepted the provider s vaccine recommendations when they were presented as required immunizations to maintain optimal disease prevention. The current vaccine schedule is the only one recommended by the CDC and the AAP. Alternative schedules have not been studied. 30