1. Practical Approaches for Optimizing Childhood Immunization Rates

2. Educational Learning Objectives At the conclusion of this presentation, the participant should be able to: Acknowledge the indications and recommendations for current vaccines and vaccine schedules across childhood populations Address immunization barriers frequently encountered during patient/caregiver communications regarding safety, efficacy, and possible misinformation Implement strategies for improving immunization rates within one’s clinical practice, taking into account current immunization schedules and guidelines

3. Stay current with the immunization schedule, recommendations Identify and address barriers Educate parents Address safety concerns Implement organizational & systems strategies Expand access, eg, walk-in “shot clinic” Your recommendation is important! Important Considerations for Increasing Childhood Vaccination Rates

4. 2011 Child Immunization Schedule HepB = Hepatitis B; RV = Rotavirus; DTaP = Diphtheria, Tetanus, Pertussis; Hib = Haemophilus influenzae type b; PCV = Pneumococcal; IPV = Inactivated Poliovirus; MMR = Measles, Mumps, Rubella; HepA = Hepatitis A; MCV = Meningococcal; PPSV = Pneumococcal Polysaccharide ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Feb 2011.

5. Childhood Catch-up Schedule ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Feb 2011.

6. Vaccination Coverage Children 19–35 Months, United States, National Immunization Survey CDC. MMWR Morb Mortal Wkly Rep. 2010;59(36):1171-1177.

7. Recent Updates in Child Schedule Rotavirus –Contraindication: infants with severe combined immunodeficiency (SCID) Hib –Matching products with primary vs booster doses Pneumococcal –Integration of PCV13 Polio –Emphasize importance of booster dose at 4 to 6 years Influenza –Universal annual vaccination ≥ 6 months MMR –No preference MMR or MMRV for 1 st dose (age 12 to 47 months) Hep A –Family members of international adoptees Tdap

8. Hepatitis B Dose 3 should be administered ≥ 16 wk after dose 1 Combination vaccines cannot be used for the birth dose Adapted from Table 1, ACIP General Recommendations on Immunization: MMWR Recomm Rep. 2006;55(RR-15):1-48. *HB Immunoglobulin should also be administered at birth for infants whose mothers are HBsAg positive Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 1Birth*Birth1–4 mo4 wk 21–2 mo4 wk2–17 mo8 wk 36–18 mo24 wk

9. Hepatitis B Perinatal Transmission* If mother positive for HBsAg and HBeAg –70–90% of infants infected –90% of infected infants become chronically infected If positive for HBsAg only –5–20% of infants infected –90% of infected infants become chronically infected *in the absence of postexposure prophylaxis

10. Why Rotavirus? > 400,000 physician visits > 200,000 ED visits > 50,000 hospitalizations > $1 billion in total health care costs CDC. MMWR Recomm Rep. 2006;55(RR12):1-13.

11. Rotavirus Vaccines and Schedules CDC. MMWR Recomm Rep. 2009;58(RR2):1-25. CharacteristicRV5RV1 Number of doses in series32 Recommended age for doses2, 4, and 6 mo2 and 4 mo Minimum age for 1 st dose6 wk Maximum age for 1 st dose14 wk and 6 days Minimum interval between doses4 wk Maximum age for last dose8 mo and 0 days RV5: RotaTeq ® RV1: Rotarix ®

12. CDC. MMWR Recomm Rep. 2009;58(RR2):1-25. Rotavirus Vaccine Harmonized Recommendations “..vaccination should not be deferred because the product used for previous dose(s) is not available or is unknown. In these situations, the provider should continue or complete the series with the product available. If any dose in the series was RV5, or the vaccine product is unknown for any dose in the series, a total of 3 doses of rotavirus vaccine should be administered.” Dose # RV1 (Rotarix) RV5 (RotaTeq) ACIP Recommendation Usual schedule2, 4 mo2, 4, 6 moSame 1 Earliest Latest 6 wk 20 wk 6 wk 12 wk 6 wk 14 wk 6 days 2 Earliest Latest 10 wk 24 wk 10 wk 32 wk 10 wk 8 mo 0 days 3 Earliest Latest __ 14 wk 32 wk 14 wk 8 mo 0 days

13. Rotavirus Vaccines – Porcine Circovirus (PCV) FDA. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm. Accessed Dec 2010. In March 2010, fragments of PCV DNA were detected in both rotavirus vaccines No evidence that PCV is a safety risk or causes illness in humans Rotavirus vaccines have been shown to be safe and effective –Strong safety records –Clinical trials in tens of thousands of patients –Clinical experience with millions of vaccine recipients

14. Updated Label for Rotarix Intussusception –Interim postmarketing safety data from Mexico –Increased risk of intussusception in the 31-day period following administration of the first dose of Rotarix –Most cases of intussusception occurred in the first 7 days FDA. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm226690.htm. Accessed Dec 2010.

15. Rotavirus Vaccines Contraindications –History of serious allergic reaction to a previous dose of vaccine –History of severe hypersensitivity to any component of the vaccine –Infants diagnosed with severe combined immunodeficiency (SCID) Precautions – Altered immunocompetence – Moderate or severe acute illness, including acute gastroenteritis – Preexisting chronic gastrointestinal disease – Previous history of intussusception CDC. MMWR Recomm Rep. 2009;58(RR2):1-25. CDC. MMWR Wkly Rep. 2010;59(22):687-688.

16. Family Physicians and Rotavirus Vaccine 2008 Survey* –45% provided rotavirus vaccine on site  ½ rate of other vaccines –35% referred elsewhere –24% did neither  3x rate of other vaccines *Campos-Outcalt D, et al. Immunization Practices of Family Physicians. 43 rd National Immunization Conference, Dallas TX, March 31, 2009. Abstract PS19.

17. DTaP Dose 5 not needed if dose 4 is given after age 4 years Adapted from Table 1, ACIP General Recommendations on Immunization. CDC. MMWR Recomm Rep. 2006;55(RR15):1-48. Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 12 mo6 wk2 mo4 wk 24 mo10 wk2 mo4 wk 36 mo14 wk6–12 mo6 mo 415–18 mo12 mo3 yr6 mo 54–6 yr4 yr

18. Recent Pertussis Outbreaks in California California Dept of Public Health. http://www.cdph.ca.gov/programs/immunize/Documents/PertussisReport2010-11-09.pdf. Accessed Dec 2010. 6,631 confirmed, probable, and suspect cases of pertussis, Jan 1–Nov 9, 2010 –State rate: 16.9 cases/100,000 –Of the hospitalized cases  58% were infants < 3 months  75% were infants < 6 months  77% of hospitalized infants < 6 months were Hispanic –10 deaths; 9 were Hispanic infants  9 were infants < 2 months at disease onset (no DTaP)  1 was an ex-28 week preemie 2 months of age (1 st dose of DTaP 15 days prior to disease onset)

19. New ACIP Recommendations Tdap Children 7 to 10 Years of Age Under-vaccinated children ages 7 to 10 years –Single-dose of Tdap –If additional doses are needed, then vaccinate according to catch- up guidance Children 7 to10 years never vaccinated against tetanus, diphtheria, or pertussis –Tdap; Td > 4 wks after Tdap; Td 6-13 mo later Further guidance will be forthcoming on timing of revaccination those who have received Tdap prior to age 11 ACIP. http://www.cdc.gov/vaccines/recs/acip/default.htm. Accessed Dec 2010.

20. Hib Dose at 6 mo of age not necessary if first 2 doses are PRP-OMP Fewer doses required if series initiated at ≥ 7 mo of age Supply shortage over, reinstate 12-15 mo booster and catch-up Approved products – PedvaxHib (Merck) – ActHIB (Sanofi) – Hiberix (GSK)---booster only CDC. MMWR Morb Mortal Wkly Rep. 2009;58(24):673-674. Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 12 mo6 wk2 mo4 wk 24 mo10 wk2 mo4 wk 36 mo14 wk6–9 mo8 wk 412–15 mo12 mo

21. Hib Products *Can immunize through age 59 months CDC. http://www.cdc.gov/vaccines/vpd-vac/hib/default.htm#ref. Accessed Dec 2010. ProductDescriptionPrimary SeriesBooster PedvaxHIB (Merck) Monovalent Hib vaccine2,4 months12-15 months* Act HIB (Sanofi Pasteur) Monovalent Hib vaccine2,4,6 months12-15 months* HIBERIX (GSK) Hib conjugate (tetanus toxoid conjugate) ---15 months*

22. 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Licensed by FDA on February 24, 2010 Serotypes in PCV13 –PCV7 types: 4, 6B, 9V, 14, 18C, 19F, 23F –Additional serotypes: 1, 3, 5, 6A, 7F, 19A Approved for use in children 6 weeks through 5 years (before the 6 th birthday) –4-dose series at ages 2, 4, 6, and 12-15 months Indications –Prevention of invasive pneumococcal disease (IPD) caused by the 13 vaccine serotypes –Prevention of otitis media caused by PCV7 serotypes CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.

23. PCV13 Recommended Schedules for Children < 24 Months CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-feb-2010-508.pdf. Accessed Dec 2010. Age at Examination (mos) Vaccination History: Total PCV7 and/or PCV13 Doses Received Previously Recommended PCV13 Regimen 2 through 6 mos 0 doses3 doses, 8 wks apart; 4 th dose at age 12-15 mos 1 dose2 doses, 8 wks apart; 4 th dose at age 12-15 mos 2 doses 1 dose, 8 wks after the most recent dose; 4 th dose at age 12-15 mos 7 through 11 mos 0 doses2 doses, 8 wks apart; 3 rd dose at 12-15 mos 1 or 2 doses before age 7 mo 1 dose at age 7-11 mos, 2 nd dose at 12-15 mos, ≥ 8 wks later 12 through 23 mos 0 doses2 doses, ≥ 8 wks apart 1 dose before age 12 mo2 doses, ≥ 8 wks apart 1 dose at ≥ 12 mo1 dose, ≥ 8 wks after the most recent dose 2 or 3 doses before age 12 mo1 dose, ≥ 8 wks after the most recent dose 4 doses of PCV 7 or other age-appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 wks after the most recent dose

24. Transition from PCV7 to PCV13 According to Number of Doses Previously Received Primary Infant SeriesBooster Dose Supplemental PCV13 Dose 2 mos4 mos6 mos≥ 12 mos*14-59 mos** PCV7PCV13 -- PCV7 PCV13 -- PCV7 PCV13-- PCV7 PCV13 *No additional PCV13 doses are indicated for children 12-23 months who received 2 or 3 doses or PCV7 before age 12 months and at least 1 dose of PCV13 at age ≥ 12months **For children with underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.

25. PCV13 Recommended Schedules for Children ≥ 24 Months CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-feb-2010-508.pdf. Accessed Dec 2010. Age at Examination (mos) Vaccination History: Total PCV7 and/or PCV13 Doses Received Previously Recommended PCV13 Regimen Healthy children 24 through 59 mos Unvaccinated or any incomplete schedule 1 dose, ≥ 8 wks after the most recent dose 4 doses of PCV7 or other age- appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 wks after the most recent dose Children 24 through 71 mos with underlying medical conditions Unvaccinated or any incomplete schedule of < 3 doses 2 doses, one ≥ 8 wks after the most recent dose and another dose ≥ 8 wks later Any incomplete schedule of 3 doses1 dose, ≥ 8 wks after the most recent dose 4 doses of PCV7 or other age- appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 wks after the most recent dose* *For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age

26. PCV13 – Children 6 through 18 Years of Age with High-risk Conditions Children 6 to18 years of age High risk for invasive pneumococcal disease –Sickle cell disease –HIV infection – Immunocompromising conditions –Cochlear implant –Cerebrospinal fluid leaks Single dose of PCV13 –Regardless of whether they have previously received PCV7 or PPSV23 CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-feb-2010-508.pdf. Accessed Dec 2010. This recommendation is an off-label use of PCV13, which is indicated for children 6 weeks through 5 years of age (prior to the 6 th birthday)

27. PPSV23 After PCV13 for Children ≥ 2 Years of Age with Underlying Medical Conditions GroupSchedule for PPSV23 Revaccination with PPSV23 Children who have sickle cell disease, functional or anatomic asplenia, HIV- infection, or other immunocompromising condition 1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13 1 dose 5 years after the 1 st dose of PPSV23 Immunocompetent children with chronic illness 1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13 Not recommended Doses of PCV13 should be completed before PPSV23 is given. No more than 2 PPSV23 doses are recommended. CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-feb-2010-508.pdf. Accessed Dec 2010.

28. Transition from PCV7 to PCV13 When PCV13 is available, unvaccinated and incompletely vaccinated children should receive PCV13 (not PCV7) If only PCV7 is available in office, unvaccinated and incompletely vaccinated children should receive PCV7; these children should complete the series with PCV13 at subsequent visits Children for whom the supplemental PCV13 dose is recommended should receive it at their next medical visit. Active recall is not being recommended CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.

29. Inactivated Poliovirus Vaccine Last dose after age 4 - 6 mo minimum interval from penultimate dose Adapted from Table 1, ACIP General Recommendations on Immunization. MMWR Recomm Rep.2006;55(RR15):1-48. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(30):829-830. Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 12 mo6 wk2 mo4 wk 24 mo10 wk2–14 mo4 wk 36–18 mo14 wk3–5 yr6 mo 44–6 yr18 wk

30. Outbreaks Following Wild Poliovirus (WPV) Importations–WHO European Region, 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(43):1393-1399. 1 st WPV importation into European Region since being declared polio-free in 2002 476 confirmed cases –458 in Tajikistan –14 in Russia –3 in Turkmenistan –1 in Kazakhstan

31. Influenza Morbidity and Mortality H1N1: US, April 2009–March 2010 Age GroupCasesHospitalizationsDeaths 0-17 yr19,000,00086,0001,270 18-64 yr35,000,000158,0009,420 ≥ 65 yr6,000,00026,0001,580 Total60,000,000270,00012,270 CDC. http://www.cdc.gov/h1n1flu/estimates/April_March_13.htm. Accessed Dec 2010.

32. Annual Influenza Vaccine Is Recommended for: All people* age 6 months and older! CDC. MMWR Recomm Rep. 2010;59(RR8):1-62. * Without contraindications

33. 2010–2011 Influenza Season 2010-2011 Trivalent Influenza Vaccines –A/California/7/2009(H1N1)-like virus –A/Perth/16/2009(H3N2)-like virus –B/Brisbane/60/2008-like virus Current information from the CDC and FDA –http://www.cdc.gov/vaccines/vpd-vac/flu/default.htm#ref –http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ ucm094045.htm CDC. MMWR Recomm Rep. 2010;59(RR8):1-62. CDC. http://www.cdc.gov/vaccines/vpd-vac/flu/default.htm#ref. Accessed Dec 2010. FDA. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm. Accessed Dec 2010.

34. 2010–2011 Influenza Season Vaccines for Children (< 18 years) VaccineTrade NameAge Group Route of Administration TIVFluzone; sanofi ≥ 6 months Intramuscular TIVFluvirin; Novartis ≥ 4 years Intramuscular TIVFluarix; GSK ≥ 3 years Intramuscular TIVAfluria*; CSL ≥ 9 years Intramuscular LAIVFluMist; MedImmune 2–49 yearsIntranasal TIV: trivalent inactivated influenza vaccine; LAIV: live attenuated influenza vaccine *FDA-approved for use ≥ 6 months; however ACIP does not recommend use in children 6 months to 8 years due to increased risk of fever and febrile seizures reported among young children < 5 years who received a similar vaccine in Australia 2010. CDC. MMWR Recomm Rep. 2010;59(RR8):1-62. CDC. MMWR Morb Mortal Wkly Rep. 2010;59(31):989-992.

35. Trivalent Inactivated Influenza Vaccine (TIV) and Live, Attenuated Influenza Vaccine (LAIV) CategoryTIVLAIV AdministrationIMIntranasal Primary immune responseSerum antibodies Serum & mucosal antibodies FormulationInactivatedLive attenuated Approved age and risk groups ≥ 6 mo (healthy & high risk) 2–49 yrs (healthy) StorageRefrigerated CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.

36. Influenza Vaccination for Children–1 or 2 Doses? CDC. MMWR Recomm Rep. 2010;59(RR8):1-62.

37. MMR May be administered as MMRV if 12 mo-12 yr of age, but minimal interval is 3 mo ACIP Summary Recommendations. www.immunize.org/catg.d/p2010.pdf. Accessed Dec 2010. Dose #Recommended Age Minimum AgeRecommended Interval Minimum Interval 112–15 mo12 mo3–5 yr4 wk 24–6 yr13 mo

38. US Measles Cases Measles increase in 2008 not due to a greater number of imported cases, but was the result of greater transmission after importation CDC. MMWR Morb Mortal Wkly Rep. 2008;57(33):893-896. Cases of imported measles* as a proportion of all measles cases–US 1997 to July 2008 Cases of measles by vaccination status (2008)

39. Sugarman D, et al. Pediatrics. 2010;125(4):747-755. 2008 Measles Outbreak–The Role of Intentionally Undervaccinated 7-year-old intentionally unvaccinated, returned from Switzerland infected with measles Result: –839 exposed persons –11 additional cases (unvaccinated children) –1 infant hospitalization (too young to be vaccinated) –48 children too young to be vaccinated were quarantined  Family cost = $775/child –Further spread halted due to  High 2-dose vaccination coverage  Absence of vaccine failure  Strong outbreak response –Net public sector cost = $10,376 per case –Total outbreak costs = $176,980

40. MMRV Vaccine Safety Datalink Study CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10):258-260. Children 12 to 23 months; febrile seizures 7–10 days post-vaccination MMRVMMR + V Number of recipients43,353314,599 Rate of febrile seizures9 per 10,0004 per 10,000 Adjusted odds ratio = 2.3; 95% CI: 1.62–3.2; P < 0.0001

41. Adjudication of Febrile Seizure Incidence Following MMRV Pre-adjudicated Seizure ReportsAdjudicated Seizure Data Adjudication panel: Drs S. Michael Marcy, Robert Riewerts, and Suresh Gurbani – Reviewed medical records (blinded to vaccination dates) – Confirmed seizure diagnosis based on Brighton Collaboration criteria Post-adjudication seizure data for days 5-12 postvaccination: – MMRV: 0.70/1000 – MMR + V: 0.32/1000 – Relative risk = 2.2 (95% CI = 1.04, 4.65) Jacobsen SJ, et al. Vaccine. 2009;27:4656-4661.

42. MMRV: Recent Issues ACIP position –Age 12 through 47 months for first dose: no preference –Dose 2 and any dose at age > 48 months  Combinations generally preferred  Considerations  Provider assessment  Patient preference  Potential for adverse events CDC. MMWR Recomm Rep. 2010;59(RR3):1-13.

43. Varicella “MMRV vaccine can be used in place of trivalent MMR vaccine and monovalent varicella vaccine to implement the recommended 2-dose vaccine policies for prevention of measles, mumps, rubella, and varicella” Note: a two-fold increase in the risk of febrile seizures is associated with MMRV versus MMR and Varicella vaccines administered separately and simultaneously CDC MMWR Recomm Rep. 2007;56(RR04):1-40. CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10);258-260 Broder K, et al. Presented at the ACIP June 25, 2009. Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 1 12–15 mo12 mo3–5 yr 12 wk (age < 13) 4–8 wk (age ≥ 13) 2 4–6 yr15 mo

44. Hepatitis A New recommendations for families of international adoptees CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007. Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 112–23 mo12 mo6–18 mo6 mo 218–41 mo18 mo

45. Hepatitis A: Families of International Adoptees Hep A vaccination –All previously unvaccinated persons who anticipate close personal contact with an international adoptee from countries of high or intermediate endemicity during the first 60 days following arrival in the US 1 st dose of Hep A vaccine –As soon as adoption is planned –Ideally at least two weeks prior to the arrival of the adoptee CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.

46. Meningococcal Vaccine for High Risk Children Meningococcal conjugate vaccine (MCV4) 2-dose primary series Children 2 to10 years –Persistent complement component deficiency –HIV –Anatomic or functional asplenia ACIP. http://www.cdc.gov/vaccines/recs/acip/default.htm. Accessed Dec 2010.

47. Zhou F, et al. Arch Pediatr Adolesc Med. 2005;159:1136-1144. Immunization Impact † DTaP, Hib, IPV, MMR, HepB, varicella (not included: rotavirus, HepA, PCV7, influenza, MCV-4, HPV) $1 spent =$5 in direct medical costs $11 in societal costs Vaccine Programs † 2001 Birth Cohort ( N = 3,803,295) CasesDeathsTotal Costs Without14,330,37633,564$46,557 million With 708,372 463 $482 million

48. Parental Concerns About Vaccines Freed G, et al. Pediatrics. 2010;125:654-659. Parental PerspectivePercent Vaccines are a good way to protect children 90 Generally follow doctor’s recommendations 88 Concerned about adverse effects 54 Refused at least 1 recommended vaccine 12 Of those who refused MMR, personally know someone harmed by MMR 40

49. Public Confidence in Vaccines Public confidence in vaccines is affected by a number of factors, including: –Product safety and efficacy –Anecdotal experience/information –Prevalence of disease –Recommendations by governmental committees and professional societies –Physician recommendations –Media coverage –Vaccine monitoring and surveillance systems

50. Antigen Burden Vaccine1960198020002010 Smallpox 200 Diphtheria 1111 Tetanus 1111 Pertussis 3000 55 Polio 15 MMR 24 Hib 22 Varicella 69 PCV7/PCV13 814 HepB 11 HepA 4 HPV4 4 Rotavirus 20 MCV4 5 Influenza 12 Total 32173041126177 Offit P, et al. Pediatrics. 2002;109:124-129. Marshall G. The Vaccine Handbook. PCI Books: 2010

51. Alternative Vaccination Schedules The Dr. Bob Sears’ alternative schedule Dr. Bob Sears’ strategy for addressing parent concerns Dr. Paul Offit’s analysis of this strategy

52. Dr. Bob Sears’ Alternative Vaccine Schedule Sears RW. The Vaccine Book. New York, NY: Little Brown & Company: 2007.

53. Dr. Bob Sears’ Alternative Vaccine Schedule Marshall G. The Vaccine Quarterly. 2009;3[1]:17. ParameterDr. Bob SearsACIP Total visits to completion15 visits4 or 5 visits Age at completion42 months15 or 18 months

54. Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e169. Critique of Dr. Bob Sears’ Alternative Schedule ArgumentThe Truth Vaccine-preventable diseases are not that serious and are often not seen in practice. Vaccine-preventable diseases are serious and can result in death. Anecdotal experience in practice does not trump national surveillance data. Vaccines are recommended for protection of the public at large, not individuals. Every individual benefits from receiving vaccines– they become immune to the disease and, as long as others are immunized, they have less chance of exposure. Vaccines are not adequately tested for safety. Vaccines are among the most thoroughly tested pharmaceuticals. The post-licensure safety net is robust. Reports in VAERS and language in the Package Insert (PI) constitute accurate profiles of vaccine side effects. VAERS reports do not establish causality and the PI lists any reported events, whether causally related or not. Parents’ fears should be indulged by offering alternative schedules. Parents’ fears should be assuaged by explaining the scientific findings.

55. Smith M, Woods C. Pediatrics. 2010;125(6):1134-1141. On-time Vaccine Receipt in the 1 st Year and Neuropsychological Outcomes at 7–10 Years Cohort: children born 1993–1997 –Vaccines per immunization schedules during 1 st year 2 Hep B; 3 DTP; 3 Hib; 2 Polio (2:3:3:2) 42 Neuropsychological tests 2003–2004 Timely vaccination –Better performance on 12 outcomes in univariate testing –Better performance on 2 outcomes in multivariate analyses No differences favored delayed vaccine receipt

56. Institute of Medicine Immunization Safety Reviews 2004 “…the body of epidemiological evidence favors rejection of a causal relationship between the MMR vaccine and autism… [and] favors rejection of a causal relationship between thimerosal-containing vaccines and autism.” Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10101#toc. Accessed December 2009. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10208#toc. Accessed December 2009. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10997#toc. Accessed December 2009.

57. Wakefield A, et al, MMR and Autism Timeline Smith M, Marshall G. Pediatric Annals. 2010;39(8):476-482. 1998200420092010 Wakefield Lancet publication suggests a link between MMR and autism IOM ISRC favors rejection of causal relationship between MMR and autism Vaccine court denies compensation to petitioners claiming MMR and thimerosal combine to cause autism British General Medical Council concludes that Wakefield violated research ethics 10 of 13 original authors of Lancet paper retract interpretation of study Wakefield paper formally retracted by Lancet

58. Madsen KM, et al. Pediatrics. 2003;112:604-606. Autism Incidence After Vaccine Formulation Changes Thimerosal-containing vaccines removed Autism Incidence per 10,000 Persons

59. Madsen KM, et al. N Engl J Med. 2002;347:1477-1482. Danish Cohort Study Population of Denmark Children born between 01/01/91 and 12/31/98 The Past MMR 1,647,504 person-yr No MMR 482,360 person-yr The Present Autism: 263 ASD: 345 Autism: 53 ASD: 77 Relative risk: Autism: 0.92 (0.68-1.24) ASD: 0.83 (0.65-1.07)

60. Hviid A, et al. JAMA. 2003;290:1763-1766. Danish Cohort Study Population of Denmark Children born between 01/01/90 and 12/31/96 The Past Thimerosal 1,220,006 person-yr No thimerosal 1,660,159 person-yr The Present Autism: 104 ASD: 321 Autism: 303 ASD: 430 Relative risk: Autism: 0.85 (0.60-1.20) ASD: 1.12 (0.88-1.43)

61. Price C, et al. Pediatrics. 2010;126:656-664. Infant Exposure to Thimerosal in Vaccines and Immunoglobulins; Risk of Autism A Case-Control Study Children born between 1/01/94 and 12/31/99 ASD: autism spectrum disorder The Past 101.13 μg 103.54 μg The Present ASD (N = 256) Controls (N = 752) Odds ratio: 0.967 Birth to 7 month Mean Cumulative Ethylmercury Exposure Risk Factor: increase of 1 μg/kg ethylmercury from birth through 7 months

62. Omnibus Autism Proceedings Theories of general causation –MMR and thimerosal-containing vaccines combine to cause autism –Thimerosal-containing vaccines cause autism –MMR causes autism (dropped) Three test cases per theory

63. Theory 1 February 12, 2009

64. Theory 2 March 12, 2010

65. OAP Findings “… the evidence was overwhelmingly contrary to the petitioners’ contentions. The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning most of the key points…” Special Master Hastings. Office of Special Masters No. Cedillo v. SDHHS, 98-916V: 02/12/09 “The witnesses setting forth this improbable sequence of cause and effect were outclassed in every respect by the impressive assembly of true experts in their respective fields who testified on behalf of respondent….” Special Master Vowell. Office of Special Masters No. Dwyer v. SDHHS, 03-1202V: 03/12/09 Special Master Vowell. Office of Special Masters No. 01-162V: 02/12/09

66. Marshall GS, et al. The Vaccine Handbook. Lippincott Williams + Wilkins; 2004. VAERS reporting. http://www.cdc.gov/vaccines/Pubs/surv-manual/chpt21-surv-adverse-events.htm#4. Accessed Dec 2009. CDC. MMWR Morb Mortal Wkly Rep. 1988;37(13):197-200. Vaccine Adverse Event Reporting System Postmarketing surveillance system Mandatory reporting by health care providers –Occurrence of events listed as contraindications –Occurrence of events listed in the Reportable Events Table Voluntary reporting: any event by any one Intent: hypothesis generation not hypothesis testing

67. Strategies for Improving Childhood Immunization Rates

68. Identify and Address Barriers Patient Issues for Vaccination Awareness –Disease –Vaccine –Personal risk Provider Recommendation Misconceptions / fears –About vaccine –About health care system Access & ability to pay

69. Improving Vaccination Rates – Provider Issues Know the facts Recommend vaccinations to your patients Get organized and use systems approaches –Ensure offering and administration of vaccine Automatic processes that empower nurses are effective Address convenience, efficiency, durability Evaluate and provide feedback Consider new paradigms –New venues –Extend vaccination season Practice what we preach (get vaccinated!) Nichol KL. Cleve Clin J Med. 2006;73:1009-1015.

70. Shots Immunization App - Free For iPhone/iPod, iPad, Android, Blackberry and PC Select vaccine name for information on –High Risk Indications –Adverse Reactions –Contraindications –Catch-up –Administration –Risk Communication –Epidemiology www.ImmunizationEd.org Available on iTunes Store Content includes Childhood, Adolescent, and Adult Immunization Schedules for the US

71. Receive Updates from the CDC via email: http://www.cdc.gov/vaccines/pubs/default.htm

72. Email Updates from the Immunization Action Coalition: http://www.immunize.org/subscribe/http://www.immunize.org/subscribe/

73. Provider Recommendation Can Overcome Negative Attitudes Among Patients Vaccination Rates Among High Risk Patients With Negative Attitudes Nichol KL, et al. J Gen Intern Med. 1996;11:673-677. HCP: Health care provider

74. Standing Orders Are Among the Most Effective Strategies Nonphysicians offer and administer vaccinations Established with physician approved policies and protocols Locations: –Clinics and hospitals http://www.immunize.org/standing-orders/ CDC. http://www.cdc.gov/vaccines/recs/rate-strategies/adultstrat.htm. Accessed Dec 2010. McKibbin LJ, et al. MMWR Recomm Rep. 2000;49 (RR1):15-26.

75. Patient and Provider Reminders Vaccinations Due or Past Due Patient/parent –Telephone, letter/postcard Provider –Computerized record reminders –Chart reminders Jacobson V, Szilagyi P. Cochrane Database Syst Rev. 2005;(3):CD003941.

76. Provider Assessment and Performance Feedback Retrospectively assess the delivery of vaccine(s) Incorporates principles of continuous improvement AFIX –Assessment –Feedback –Incentives –eXchange Comprehensive Clinic Assessment Software Application (CoCASA) Immunization Information System (IIS) CDC. http://www.cdc.gov/vaccines/programs/afix/overview.htm. Accessed Dec 2010. The Community Guide. http://www.thecommunityguide.org/vaccines/universally/index.html. Accessed Dec 2010.

77. Expanding Access Consider new paradigms –New venues, walk-in clinics –Extended hours for vaccinations –Extend vaccination season Nichol KL. Cleve Clin J Med. 2006;73:1009-1015.

78. The Community Guide. http://www.thecommunityguide.org/vaccines/universally/index.html. Accessed Dec 2010. Briss PA, et al. Am J Prev Med. 2000;18(suppl 1):35-43. Evidence-based Methods for Improving Immunization Rates Reducing client out-of-pocket costs Vaccination programs in schools Vaccination programs in WIC settings Client reminder and recall systems Vaccination requirements for child care and school Provider reminder systems when used alone Standing orders when used alone Provider assessment and feedback

79. Summary Critical provider issues for increasing childhood vaccination rates –Stay current with the immunization schedule, recommendations –Identify and address barriers –Educate parents –Address safety concerns –Implement organizational & systems strategies –Expand access, eg, walk-in “shot clinic” –Your recommendation is important!

80. Resources

81. Resources for Providers Immunization Schedules www.cdc.gov/vaccines/recs/schedules/ ACIP recommendations & provisional recommendations www.cdc.gov/vaccines/pubs/ACIP-list.htm www.cdc.gov/vaccines/recs/provisional/default.htm The Immunization Action Coalition: vaccine information for the public and health professionals www.vaccineinformation.org The Guide to Community Preventive Services. Vaccine recommendations www.thecommunityguide.org/vaccines/index.html Assessment, Feedback, Incentives, and Exchange (AFIX) www.cdc.gov/vaccines/programs/afix/default.htm National Foundation for Infectious Diseases www.nfid.org Centers for Medicare & Medicaid Services www.cms.hhs.gov

82. Resources for Patients and Parents Guide to evaluating information on the web www.cdc.gov/vaccines/vac-gen/evalwebs.htm CDC Vaccine Information Statements (VISs) http://www.cdc.gov/vaccines/pubs/vis/default.htm Vaccine Safety www.cdc.gov/Features/VaccineSafety National Network for Immunization Information (NNII) www.immunizationinfo.org Allied Vaccine Group www.vaccine.org Immunization Action Coalition (IAC) www.immunize.org Vaccine Education Center at CHOP www.vaccine.chop.edu TCH Center for Vaccine Awareness and Research www.texaschildrens.org/carecenters/vaccine/default.aspx