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Pneumococcal Disease in Children: P.S. It Matters

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

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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 DiseaseClinical SyndromesActive Bacterial Core Surveillance USA 2006–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

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

  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) 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 PCV7 introduced Age Group 2007 vs baseline* (years) (% reduction) 120 < 5 76 100 5–17 43 40 18–49 50–64 18 80 Cases/100,000 population ≥ 65 37 60 40 20 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year *Baseline is 1998-1999 Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

  15. Direct Effect of Vaccination: Invasive Pneumococcal Disease Among Children < 5 Years, 1998/99–2007 PCV7 introduced 90 80 Serotype group 70 PCV7 type Non-PCV7 type 60 19A 50 Cases/100,000 population 40 30 20 10 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

  16. Invasive Pneumococcal Disease (IPD) Mortalityin Children < 2 Years; Vital Records USA 1.0 0.9 0.8 0.7 0.6 Mortality Rate per 100,000 Population 0.5 0.4 0.3 Overall IPD Mortality Pneumococcal Meningitis Mortality Pneumococcal Septicemia Mortality 0.2 0.1 0 1995 1996 1997 1998 1999 2000 2001 Redelings MD, et al. Arch Pediatr Adolesc Med. 2005;159:195-196.

  17. Herd Immunity: Invasive Pneumococcal Disease Among Adults ≥ 65 Years, 1998/99–2007 PCV7 introduced 40 35 *92% reduction in PCV7 serotypes, 2007 vs baseline 30 25 Serotype group Cases/100,000 Population 20 PCV7 type Non-PCV7 type 15 19A 10 5 * 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year *Baseline is 1998-1999 Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

  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 DiseaseMetropolitan Atlanta, Georgia 18 16 14 12 10 Cases per 100,000 Persons 8 6 4 2 0 Bacteremia Meningitis Pneumonia Bacteremia Meningitis Pneumonia Children < 18 years Adults ≥ 18 years 2000/01 2001/02 2002/03 2003/04 *Clinical syndromes with significant trends over time 2000/2001 to 2003/2004; P≤ 0.05 Albrich WC, et al. Clin Infect Dis. 2007;44:1569-1576.

  20. ABCIncidence of Pneumococcal Meningitis by PCV7 ST Group Over Time: All Ages 1.2 Non-PCV7 STs PCV7-related STs 1.0 PCV7 STs 0.8 Meningitis Cases/100,000 Persons 0.6 0.4 0.2 0.0 1998–1999 2000–2001 2002–2003 2004–2005 Hsu HE, et al. N Engl J Med. 2009;360:244-256.

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

  22. PCV Efficacious in Reducing Radiologically Confirmed Pneumonia in Children Navajo, USA (Rural) American Indians PCV-7 Cluster randomized VE: -2%; P > 0.05 The Gambia PCV-9 DBRCT VE: 37%; 95%CI 27, 45% Northern California, USA PCV-7 DBRCT VE: 30%; 95%CI 11, 46% Philippines (Rural) PCV-11 DBRCT VE: 22.9; 95%CI -1, 41 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) 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. VE: vaccine effectiveness

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

  25. PCV7 and Community Acquired PneumoniaRetrospective 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 SimonsenL, et al.mBio. 2011;2:e00309-e00310.

  27. Efficacy of PCV7 for Acute Otitis Media (AOM)Kaiser Permanente Randomized Double-Blind Trial *number of episodes in 6months/number of episodes in 1 year N = 37,868 infants; vaccine at 2, 4, 6, and 12 to 15 months of age; meningococcal vaccine as control Black S, et al. Pediatr Infect Dis. 2000;19:187-195.

  28. Efficacy of PCV7 for Acute Otitis Media (AOM)Finnish Otitis Media Vaccine Trial N = 1662 infants; vaccine at 2, 4, 6, and 12 months of age; Hepatitis B vaccine as control Eskola J, et al. N Engl J Med. 2001;344:403-409.

  29. Ambulatory Visits for Acute Otitis Media and Antibiotic Prescriptions1997–2004 MarketScan Databases 2500 2000 1500 Rate (per 1000 person-years) 1000 Ambulatory visits for AOM 500 Non-AOM ARI visits Antibiotic prescriptions for AOM visits Antibiotic prescriptions for non-AOM ARI visits 0 1997 1998 1999 2000 2001 2002 2003 2004 Year AOM: acute otitis media; ARI: acute respiratory infection Zhou F, et al. Pediatrics. 2008;121:253-260.

  30. Impact of PCV7 on Otitis Media Reduction in Antibiotic Use Fireman B, et al. Pediatr Infect Dis J. 2003;22:10-16.

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

  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 Children < 5 years Adults > 50 years White bars: penicillin susceptible; gray bars: penicillin intermediate; black bars: penicillin resistant Moore M, et al. J Infect Dis. 2008;197:1016-1027.

  38. Outpatient Antibiotic Prescribing and S. pneumoniae Serotype 19A IPD Isolates Hicks L, et al. Clin Infect Dis. 2011;53:631-639.

  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 AOMFrench Prospective Study Antibiotics (+): Antibiotic use within the last 3 months Cohen R, et al. Pediatr Infect Dis J. 2006;25:1001-1007.

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

  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.

  46. Transition from PCV7 to PCV13 Accordingto Number of Doses Previously Received *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 *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 • 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 *On or after March 12, 2010; unweighted average across sites CDC. MMWR Wkly Rep. 2011;60:1477-1481.

  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.

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