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Pneumococcal Disease in Children: P.S. It Matters.

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1 Pneumococcal Disease in Children: P.S. It Matters

2 Learning Objectives Describe the current burden of pneumococcal disease since the introduction of pneumococcal conjugate vaccines Discuss the current recommended immunization schedule in infants and children to prevent pneumococcal disease Review and implement strategies for improving immunization rates within one’s clinical practice, including being able to answer frequently encountered questions that involve safety, efficacy, and possible misinformation

3 Streptococcus pneumoniae A leading bacterial cause of serious illness among children and adults worldwide Gram-positive bacteria Polysaccharide capsule important pathogenic factor; prevents phagocytosis Over 90 distinct capsular types identified Protection is serotype specific; some cross protection within serogroups Lynch J, Zhanel G. Semin Respir Crit Care Med. 2009;30(2):189-209.

4 Pneumococcal Disease Influenza and pneumococcal disease are the most common causes of vaccine-preventable disease and death in the US Major pneumococcal clinical syndromes include –Pneumonia –Bacteremia –Meningitis Invasive pneumococcal disease (IPD): isolation of S. pneumoniae from a normally sterile site (blood, CSF, pleural, pericardial, peritoneal, bone or joint fluid) Pneumococcal diseases encompass invasive and non- invasive syndromes Adapted from CDC. http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed Nov 2011.

5 Invasive Pneumococcal Disease Clinical Syndromes Active Bacterial Core Surveillance USA 2006–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

6 S. Pneumoniae ABCs Data USA: 2009 Invasive Pneumococcal Disease (Inpatient and Outpatient) CDC ABC Surveillance report. http://www.cdc.gov/abcs/reports-findings/survreports/spneu09.html. Accessed Nov 2011.

7 S. Pneumoniae ABCs Data–2009 All Age Groups Meningitis 4.8% Bacteremia without Focus 19.2% Pneumonia with Bacteremia 70.4% Not Categorized 5.6% CDC ABC Surveillance report. http://www.cdc.gov/abcs/reports-findings/survreports/spneu09.html. Accessed Nov 2011. Based on a total of 4,166 IPD cases

8 S. pneumoniae Carriage and Infection Nasopharyngeal carriage of S. pneumoniae necessary for transmission of bacteria and invasive disease Person-to-person contact; respiratory droplets Autoinoculation Seasonal patterns S. pneumoniae can be present in the nasopharynx commensally and not cause disease Pneumococcal disease. http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed Nov 2011.

9 Pneumococcal Disease in Children Bacteremia without known site of infection most common clinical presentation Bacteremic pneumonia accounts for 12–16% of IPD among children 2 years and younger S. pneumoniae leading cause of bacterial meningitis among children 2 months to 10 years –Group B streptococcus leading cause of meningitis in children < 2 months Common cause of acute otitis media Pneumococcal disease. http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed Nov 2011. Thigpen M, et al. N Engl J Med. 2011;364:2016-2025.

10 Pneumococcal Acute Otitis Media (AOM) Most common reason for physician office visits among pre-school aged children in the US 83% of children experience ≥ 1 episode of AOM before 36 months of age S. pneumoniae most common bacterial cause of AOM (30–50% of episodes) AOM most common reason for antibiotic prescriptions among US children Zhou F, et al. Pediatrics. 2008;121:253-260.

11 Annual Global Pneumococcal Deaths in Children #1 Vaccine-Preventable Cause of Death in Children < 5 Years Worldwide Deaths per 100,000 children < 5 years O’Brien K, et al. Lancet. 2009;374:893-902.

12 Risk Factors for Pneumococcal Diseases or Complications Immunocompetent children –Chronic heart disease –Chronic lung disease –Diabetes mellitus –Cerebrospinal fluid leaks –Cochlear implant Children with functional or anatomic asplenia –Sickle cell disease and other hemoglobinopathies –Congenital or acquired asplenia, or splenic dysfunction Children with immunocompromising conditions –HIV infection –Chronic renal failure and nephrotic syndrome –Diseases associated with treatment with immunosuppressive drugs or radiation therapy; or solid organ transplantation –Congenital immunodeficiency CDC. MMWR Recomm Rep. 2010;59(RR-11):1-18.

13 Vaccines for Invasive Pneumococcal Disease (before PCV-13) PPSV23PCV7 Year introduced19832000 Vaccine constituents Mixture of 23 purified capsular polysaccharides; phenol preservative Mixture of 7 purified capsular polysaccharides conjugated to nontoxic diphtheria toxin (CRM 197 ); aluminum phosphate adjuvant Immune response T-cell independent response; poor inducer of immunologic memory; poorly immunogenic in children ≤ 2 years T-cell response; immunologic priming and memory response; good antibody response in infants/young children Recommendations All adults ≥ 65 years; high-risk individuals ages 2-64 years; adults 19-64 years with asthma or smokers; single dose Routine vaccination of children < 24 months and high risk children 24-59 months; doses at 2, 4, 6 months of age; booster at 12-15 months Duration of protection High antibody titers for 1-2 years; wane over 5-10 years At least 2-3 years Revaccination 5 years after the 1st dose for individuals at high risk Not recommended following an age- appropriate primary series Pneumococcal disease. http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed Nov 2011. Lynch J, Zhanel G. Sem Respir Crit Care Med. 2009;30(2):189-209.

14 Changes in Overall Invasive Pneumococcal Disease, 1998–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41. Cases/100,000 population 0 20 40 60 100 80 120 1998199920012000200220032004200520062007 Year PCV7 introduced Age Group 2007 vs baseline* (years) (% reduction) < 5 5–17 18–49 50–64 ≥ 65 76 43 40 18 37 *Baseline is 1998-1999

15 Direct Effect of Vaccination: Invasive Pneumococcal Disease Among Children < 5 Years, 1998/99–2007 Cases/100,000 population 0 10 20 30 40 50 60 70 80 90 1998199920012000200220032004200520062007 Year PCV7 introduced Serotype group PCV7 type Non-PCV7 type 19A Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

16 Redelings MD, et al. Arch Pediatr Adolesc Med. 2005;159:195-196. Invasive Pneumococcal Disease (IPD) Mortality in Children < 2 Years; Vital Records USA 1995199619971998199920002001 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 Mortality Rate per 100,000 Population Overall IPD Mortality Pneumococcal Meningitis Mortality Pneumococcal Septicemia Mortality

17 Herd Immunity: Invasive Pneumococcal Disease Among Adults ≥ 65 Years, 1998/99–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41. Cases/100,000 Population 0 5 10 15 20 25 30 35 40 1998199920012000200220032004200520062007 Year PCV7 introduced Serotype group PCV7 type Non-PCV7 type 19A *92% reduction in PCV7 serotypes, 2007 vs baseline * *Baseline is 1998-1999

18 Herd Immunity: Invasive Pneumococcal Disease in Infants 0 to 90 days,1997–2004 Poehling K, et al. JAMA. 2006;295:1668-1674.

19 Rates of Invasive Pneumococcal Disease Metropolitan Atlanta, Georgia Albrich WC, et al. Clin Infect Dis. 2007;44:1569-1576. Cases per 100,000 Persons Adults ≥ 18 yearsChildren < 18 years Bacteremia Meningitis Pneumonia * * * * * 2000/012001/022002/032003/04 0 2 4 6 8 10 12 14 16 18 *Clinical syndromes with significant trends over time 2000/2001 to 2003/2004; P ≤ 0.05

20 ABC Incidence of Pneumococcal Meningitis by PCV7 ST Group Over Time: All Ages Hsu HE, et al. N Engl J Med. 2009;360:244-256. Meningitis Cases/100,000 Persons 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1998–19992000–20012002–20032004–2005 Non-PCV7 STs PCV7-related STs PCV7 STs

21 ABC Incidence of Pneumococcal Meningitis by PCV7 ST Group Over Time: < 2 Years Hsu HE, et al. N Engl J Med. 2009;360:244-256.

22 South Africa (Urban) PCV-9 DBRCT HIV-infected children VE: 9% (95%CI -15 to 27) HIV non-infected children VE: 25% (95%CI 4 to 41) Northern California, USA PCV-7 DBRCT VE: 30%; 95%CI 11, 46% Philippines (Rural) PCV-11 DBRCT VE: 22.9; 95%CI -1, 41 Navajo, USA (Rural) American Indians PCV-7 Cluster randomized VE: -2%; P > 0.05 Black S, et al. Pediatr Infect Dis J. 2001;20:1105-1107. Hansen J, et al. Pediatr Infect Dis J. 2006;25:779-781. Klugman KP, et al. N Engl J Med. 2003;349:1341-1348. Cutts F, et al. Lancet. 2005;365:1139-1146. Lucero MG, et al. Pediatr Infect Dis J. 2009;28:455-462. PCV Efficacious in Reducing Radiologically Confirmed Pneumonia in Children VE: vaccine effectiveness The Gambia PCV-9 DBRCT VE: 37%; 95%CI 27, 45%

23 Efficacy of PCV in Children < 2 Years 11 publications of 6 randomized controlled trials N = 57,015 children received PCV; N = 56,029 received placebo or another vaccine Vaccine-serotype IPD; RR = 0.20 (0.10-0.42); P < 0.0001 All serotypes IPD; RR = 0.42 (0.25-0.71); P = 0.001 WHO X-ray defined pneumonia; RR = 0.73 (0.64-0.85); P < 0.0001 Clinical pneumonia; RR = 0.94 (0.91-0.98); P = 0.0006 All-cause mortality; RR = 0.91 (0.81-1.01); P = 0.07 Lucero M, et al. Cochrane Database Syst Rev. 2009;4:CD004977.

24 National Estimated Changes in Rates of Pneumonia Hospitalizations Post PCV7 Grijalva C, et al. Lancet. 2007;369:1179-1186. Grijalva C, Griffin M. Expert Rev Vaccines. 2008;7:83-95. *Statistically significant decline All-cause Pneumonia; Nationwide Inpatient Sample Change comparing 2004 data with pre-PCV7 years after trend adjustment

25 PCV7 and Community Acquired Pneumonia Retrospective Cohort of Children and Adults–Washington State HMO Nelson J, et al. Vaccine. 2008;26:4947-4954.

26 Estimated PCV7-Associated Reductions in US Burden of Hospitalizations, 2000–2006 IPD Nonbacteremic Pneumococcal Pneumonia (ICD9 481 with no IPD codes) Age GroupEstimate95% CIEstimate95% CI < 28,4408,101-8,7523,3994,119-2,592 2-42,0251,766-2,2449341,590-188 5-171,5281,257-1,7723,9774,595-3,305 18-398,5927,658-9,43221,80823,411-20,094 40-647,2705,428-9,00424,61426,976-22,169 65+20,04616,851-23,01499,415110,428-87,565 Total47,89941,060-54,218154,147171,118-135,893 % Adults75%95% Simonsen L, et al. mBio. 2011;2:e00309-e00310.

27 Efficacy of PCV7 for Acute Otitis Media (AOM) Kaiser Permanente Randomized Double-Blind Trial AnalysisVaccine Efficacy (%) AOM Visits8.9 AOM Episodes7.0 Frequent AOM Episodes (3/4)*9.3 Frequent AOM Episodes (5/6)*22.8 Ventilatory Tube Placement20.1 AOM PCV7 Serotypes66.7 Black S, et al. Pediatr Infect Dis. 2000;19:187-195. N = 37,868 infants; vaccine at 2, 4, 6, and 12 to 15 months of age; meningococcal vaccine as control *number of episodes in 6months/number of episodes in 1 year

28 AnalysisVaccine Efficacy (%) AOM Any Cause6 AOM PCV7 Serotypes57 AOM Cross-reactive Serotypes51 1 st Episode AOM, PCV7 Serotypes52 Subsequent Episodes AOM, PCV7 Serotypes 45 Efficacy of PCV7 for Acute Otitis Media (AOM) Finnish Otitis Media Vaccine Trial Eskola J, et al. N Engl J Med. 2001;344:403-409. N = 1662 infants; vaccine at 2, 4, 6, and 12 months of age; Hepatitis B vaccine as control

29 Ambulatory Visits for Acute Otitis Media and Antibiotic Prescriptions 1997–2004 MarketScan Databases Zhou F, et al. Pediatrics. 2008;121:253-260. Rate (per 1000 person-years) 2500 2000 1500 1000 500 0 Year 19971998199920002001200220032004 Ambulatory visits for AOM Non-AOM ARI visits Antibiotic prescriptions for non-AOM ARI visits Antibiotic prescriptions for AOM visits AOM: acute otitis media; ARI: acute respiratory infection

30 Impact of PCV7 on Otitis Media Reduction in Antibiotic Use Fireman B, et al. Pediatr Infect Dis J. 2003;22:10-16. EndpointChange Following PCV7 Antibiotic prescriptions after the primary series ↓ by 5.7% (95% CI 4.2–7.2) Second-line antibiotics ↓ by 13.3% (95% CI 9.9–16.5) Number of antibiotic prescriptions prevented per 100 children vaccinated (from dose 1 to 3.5 years) 35

31 Black S, et al. Pediatr Infect Dis J. 2004;23:485-489. Penicillin Resistance in PCV7 Serotypes Northern California Kaiser Permanente (All ages) PCV7 Introduced

32 Invasive Pneumococcal Disease in Children < 2 Years Active Bacterial Core Surveillance (ABCs) Data Kyaw M, et al. N Engl J Med. 2006;354:1455-1463.

33 Invasive Pneumococcal Disease Penicillin Non-susceptible (≥ 2 years) ABCs Data Kyaw M, et al. N Engl J Med. 2006;354:1455-1463.

34 Effect of Introduction of PCV-7 on Drug-Resistant S. pneumoniae Kyaw M, et al. N Engl J Med. 2006;354:1455-1463.

35 Invasive Pneumococcal Disease Serotype 19A Moore M, et al. J Infect Dis. 2008;197:1016-1027.

36 Trends in Antibiotic Resistance: Serotype 19A Children < 5 Years Moore M, et al. J Infect Dis. 2008;197:1016-1027.

37 IPD and S. pneumoniae Serotypes White bars: penicillin susceptible; gray bars: penicillin intermediate; black bars: penicillin resistant Children < 5 yearsAdults > 50 years Moore M, et al. J Infect Dis. 2008;197:1016-1027.

38 Hicks L, et al. Clin Infect Dis. 2011;53:631-639. Outpatient Antibiotic Prescribing and S. pneumoniae Serotype 19A IPD Isolates AntibioticParameter 1996–1999 (n = 11,264) 2000–2003 (n = 10,811) 1996–2003 (n = 22,075) Cephalosporin Proportion, %High-prescribing sites3.46.84.9 Low-prescribing sites2.64.23.5 P-value0.320.03 Logistic regressionPoint estimate (β 1 )0.260.510.36 Odds Ratio (95% CI)1.30 (1.04-1.62)1.67 (1.41-1.98)1.43 (1.25-1.64) P-value0.02< 0.001 Macrolides Proportion, %High-prescribing sites3.46.84.9 Low-prescribing sites2.64.23.5 P-value0.320.03 Logistic regressionPoint estimate (β 1 )0.260.510.36 Odds Ratio (95% CI)1.30 (1.04-1.62)1.67 (1.41-1.98)1.43 (1.25-1.64) P-value0.02< 0.001

39 Children With New Acquisition of Serotype 19A After Finishing Primary Series PCV7 van Gils E, et al. JAMA. 2010;304:1099-1106.

40 Antibiotic Use and PCV7 in Children with AOM French Prospective Study Cohen R, et al. Pediatr Infect Dis J. 2006;25:1001-1007. Antibiotics (+): Antibiotic use within the last 3 months

41 Gertz R, et al. J Infect Dis. 2010;201:770-775. 11%, 8%, 8%, 5% Total = 32% Distribution of Penicillin Non-Susceptible Invasive Pneumococcal Isolates–ABCs 2007 (all age groups) Serotype 19A (n = 478) Serotypes 15A, 35B, 23A, 6C (n = 287) Serotype 6A (n = 38) Others (n = 32) [13 serotypes, 2 isolates nontypeable] PCV7 Serotypes (n = 61) 25.6% of 3,511 total isolates were penicillin non-susceptible

42 Expanded Serotype Coverage with PCV13

43 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 6th 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.

44 2012 Child Immunization Schedule ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Feb 2012.

45 PCV13 Recommended Schedules for Children < 24 Months CDC. MMWR Recomm Rep. 2010;59(RR-11):1-18. 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; 4th dose at age 12-15 mos 1 dose2 doses, 8 wks apart; 4th dose at age 12-15 mos 2 doses 1 dose, 8 wks after the most recent dose; 4th dose at age 12-15 mos 7 through 11 mos 0 doses2 doses, 8 wks apart; 3rd dose at 12-15 mos 1 or 2 doses before age 7 mo 1 dose at age 7-11 mos, 2nd 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

46 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.

47 PCV13 Recommended Schedules for Children ≥ 24 Months 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 CDC. MMWR Recomm Rep. 2010;59(RR-11):1-18.

48 Invasive Pneumococcal Disease Caused by Serotype 19A: A Preventable Death? June 2011, a 2-year-old girl in California died from IPD caused by serotype 19A Serotype 19A is included in PCV13, but not PCV7 The child had received 3 doses of PCV7, but had NOT received PCV13 California Dept. of Public Health identified an additional 30 PCV-13 eligible children who had developed nonfatal IPD caused by serotypes not included in PCV7 CDC. MMWR Wkly Rep. 2011;60:1477-1481.

49 Coverage with PCV13, Immunization Information System (IIS) Sentinel Sites, US March 12, 2010–June 30, 2011 Age Group (months) Enrolled in IIS in Birth Range (number) Completed PCV7 SeriesDid Not Complete PCV7 Series Number Received PCV13 (%)*Number Received PCV13 (%)* 0–11288,671--- 288,67171 12–23297,285160,56558136,72045 24–59953,295694,13532259,16014 CDC. MMWR Wkly Rep. 2011;60:1477-1481. *On or after March 12, 2010; unweighted average across sites During 2010 and 2011, evaluated PCV13-type IPD cases and vaccine coverage in children ≤ 59 months Among ~850,000 children aged 12 through 59 months with a complete PCV7 series as of March 2010, 37% received the supplemental dose as of June 30, 2011 CDC PCV13 Vaccine Effectiveness Evaluation –68% of cases of IPD due to the new serotypes in PCV13 were among vaccine-eligible children 24–59 months

50 2010 CDC ABC Data–IPD Rates All Serotypes and PCV13 Serotypes Children < 2 Years Moore M, et al. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy; Chicago, IL 2011: G1-538.

51 Frequency of Adverse Events Following Administration of PCV13 or PCV7 Adverse Event Percent PCV13 (n = 4,729)PCV7 (n = 2,760) Injection-site reaction Pain/tenderness48.854.4 Erythema (any)46.6 Induration/swelling35.337.1 Irritability70.068.4 Drowsiness/increased sleep59.258.3 Decreased appetite38.748.0 Fever36.946.7 Restless sleep/decreased sleep 36.034.4 Fever > 39°C5.37.4 Diarrhea3.13.0 Vomiting1.82.0 Rash1.11.6 CDC. MMWR Recomm Rep. 2010;59(RR-11):1-18.Data from 13 combined clinical trials

52 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 years and ≥ 8 weeks after last indicated dose of PCV13 1 dose 5 years after the 1st 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. MMWR Recomm Rep. 2010;59(RR-11):1-18.

53 PCV10 Rodgers G, Klugman K. Vaccine. 2011;29S:C43-C48. Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F First approved by the European Commission in March 2009 –For active immunization against invasive pneumococcal disease and acute otitis media in infants and children 6 weeks up to 2 years of age –Licensed globally, indications vary for countries outside of Europe –European label has been updated to include use in preterm infants –Not licensed in USA –Placebo-controlled efficacy study in Argentina, Columbia, and Panama (COMPAS) –22% reduction in community-acquired pneumonia

54 Future Developments: Pneumococcal Vaccines for Children 15-valent pneumococcal conjugate vaccine (PCV) Continue to further expand valency of PCVs Protein vaccines alone (protection independent of serotype) Addition of pneumococcal proteins to conjugate vaccines Innovative whole-cell killed pneumococci as a vaccine Adapted from Rodgers G, Klugman K. Vaccine. 2011;29S:C43-C48.

55 Estimated PCV Vaccination Coverage Children 19–35 months; NIS, 2006–2010 CDC. MMWR Wkly Rep. 2011;60:1157-1163. NIS: National Immunization Survey

56 Vaccine Concerns–Parents of Children Age 6 or Younger, 2010 Survey Vaccine Concern Parents Reporting Concern (%) Painful for children to receive so many shots during 1 doctor’s visit38 Child is getting too many vaccines in 1 doctor’s visit36 Children get too many vaccines during the first 2 years of life34 Vaccines may cause fevers32 Vaccines may cause learning disabilities such as autism30 Ingredients in vaccines are unsafe26 Vaccines are not tested enough for safety17 Vaccines may cause chronic disease16 Vaccines are given to children for diseases they are not likely to get11 Vaccine shortages will contribute to incomplete vaccinations9 Vaccines are given to children to prevent diseases that are not serious8 No concerns23 Kennedy A, et al. Health Affairs. 2011;30:1151-1159.

57 Barriers to Adequate Childhood Immunization Patient /Parent Barriers Lack of knowledge about immunizations Fears about vaccine safety Logistical problems that limit access to immunization services Provider Barriers Providers may be uninformed about immunization indications and contraindications, especially due to frequent changes/updates Logistical issues –Cost of immunizations –Vaccine storage –Vaccine availability –Lack of access to prior immunization records Missed opportunities to vaccinate Missed visits Limited time for communication about vaccine risks and benefits Systems Barriers Disruption of vaccine supply Children may qualify to receive vaccines through Vaccines for Children (VFC) program, but VFC does not reimburse providers for administration costs Burns I, Zimmerman R. J Fam Pract. 2005;54:S58-S62. AAP. Pediatrics. 2010;125:1295-1304.

58 Improving Vaccination Rates: Provider Issues Know the facts –ACIP: http://www.cdc.gov/vaccines/recs/default.htm Recommend vaccinations to your patients Address questions and concerns about vaccine safety 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/get your own children vaccinated! Adapted from Nichol KL. Cleve Clin J Med. 2006;73:1009-1015.

59 Strategies to Improve Immunization Rates Client reminder and recall systems Vaccination requirements for child care and school Parent/patient education Reducing client out-of-pocket costs Vaccination programs in schools Vaccination programs in WIC settings Standing orders Computerized record reminders Chart reminders Drop-in vaccination services Expanding access in health care settings Personal health records Office-based quality improvement activities CDC. http://www.cdc.gov/vaccines/recs/default.htm. Accessed Nov 2011. AAP. Pediatrics. 2010;125:1295-1304.

60 Summary Pneumococcal disease is a common cause of morbidity and mortality in children worldwide In the US, routine immunization with PCV7 resulted in a dramatic reduction in disease caused by vaccine serotypes, with benefits in very young children and older adults through herd immunity Invasive pneumococcal disease due to non-PCV7 serotypes increased in the years following implementation of PCV7; particularly serotype 19A PCV13 (with expanded serotype coverage) has replaced PCV7, but PCV13 coverage remains suboptimal in certain age groups Identify and address any barriers to recommended childhood immunizations Implement strategies for improving immunization rates


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