Latest information about Pneumococcal disease and its prevention from Indian perspective - as of sept 2011.
Covers latest Pneumonet data, and review from other studies like IBIS, ANSORP etc.
8. Child DEATHS Each Dot = 5,000 child deaths Black RE. The Lancet 2003; 361: 2226-2234 We are No. 1
9.
10. Countries with the greatest number of pneumococcal deaths among children under 5 years O,Brien K, et al. Lancet. 2009;374:893-902. PNEUMOCOCCAL DISEASE BURDEN TOP TEN 1
11.
12. We are missing the target (Millennium Development Goal 4) AAR =average annual rate of reduction MDG=millennium development goal U5MR in 2015 at current AAR MDG Target U5MR in 2015 85 38 Under-five mortality ratio (U5MR) projections 60 priority countries Source: UN Population Division World Population Prospects, 2004.
13.
14. PneumoNET Pan Asia Epidemiologic surveillance network to assess the burden of invasive pneumococcal disease (IPD) Nisarga RG, Balter I, Premalatha R et al, Prospective, Multinational, Active, Hospital-Based Epidemiologic Surveillance for IPD and Pneumonia Burden Among Children in Bangalore South Zone, Bangalore, India. Poster presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), 7–11 June 2011, The Hague, Netherlands
15.
16.
17.
18.
19.
20. PNUEMONET… (1 year data) RESULTS 3) BACTERIOLOGY AND ANTIBIOTIC RESISTANCE a – In 1 subject 2 different serotypes were obtained from blood and CSF (6A in CSF and 3 in blood) b – Antibiotic susceptibility was determined for 17 isolates only Table 3: Serotype Distribution and Antibiotic Resistance of IPD Isolates From Children Aged 28 Days to <60 Months (18 Isolates a ) Serotype N (%) Antibiotic Resistance b 6A 5 (27.78%) Erythromycin (2 isolates) Ceftriaxone (1 isolate) 5 3 (16.67%) 1 2 (11.11%) Trimethoprim/Sulfamethoxazole (1 isolate) 3 2 (11.11%) Trimethoprim/Sulfamethoxazole (1 isolate) 14 2 (11.11%) Erythromycin (1 isolate) Trimethoprim/Sulfamethoxazole (1 isolate) 9V 1 (5.56%) 19F 1 (5.56%) 18C 1 (5.56%) 19A 1 (5.56%) Trimethoprim/Sulfamethoxazole (1 isolate)
21.
22.
23.
24.
25.
26.
27. Serogroup distribution in India Prospective multicentre hospital surveillance of Streptococcus pneumoniae disease in India IBIS Group. The Lancet 1999; 353: 1216-1221 6A+6B 19A+19F 14 4 5 7 1 23 18 9 IBIS Group. The Lancet 1999; 353: 1216-1221
28.
29.
30. Impact of Vaccination With PCV7 IPD=invasive pneumococcal disease. OM=otitis media. IPD Pneumonia Antibiotic Resistance and Use of Antibiotics OM Carriage Indirect Effect Office Visits Cost-effectiveness
31.
32.
33.
34.
35.
36.
37. S. pneumoniae Conjugate vaccines, Potential vaccine protection Cobertura de serotipos calculada a partir de datos del Global Serotype Project (GSP) 1980 - Jun 2007. Dinleyici E, et al. Expert Rev Vaccines. 2009;8:977-986. GAVI Pneumococcal AMC TPP, Nov 2008. http://www.vaccineamc.org/files/TPP_codebook.pdf. Accessed September 3, 2009. % Neumococcal disease caused by different serotypes included into the conjugated Africa (%) Asia (%) Europa (%) Latin America (%) North América (%) Oceania (%) PCV7 39.3% 48% 67.1% 54.4% 78.1% 64.5% PCV10 62.5% 66.2% 76.2% 73.6% 80.6% 71.1% PCV13 76.9% 73.9% 88% 83.4% 88% 79.1%
Key Points Welcome to the CME on Pneumococcal infections and their prevention in children
26
Key Points As per the O’Brien report in Lancet 2009, India tops the countries with the greatest number of pneumococcal deaths in children under 5 years, ahead of China which has a higher population.
Key Points The Millennium Development Goal 4 aims to reduce mortality in children younger than 5 years by two-thirds between 1990 and 2015. However looking at this graph for 60 priority countries (including India), it seems we are still far away from that goal.
Key Points PneumoNET is the recent study that has been done to assess the burden of invasive pneumococcal disease in India
Key Points There is a paucity of data from India (and also Asia) on the disease burden due to Streptococcus pneumoniae (SP). Data on IPD are scarce. Hence this study was planned first to form a network of hospitals in India and conducted to assess the burden of invasive pneumococcal disease). One year data will be discussed.
Key Points The primary objective of this study was to Estimate incidence rates of IPD and pneumonia, as well as serotype distribution and antibiotic susceptibility of SP in children aged 28 days to <60 months in a defined target population in India. The secondary objectives were Estimate the incidence rate of clinical pneumonia and chest radiograph-confirmed pneumonia with or without pneumococcal bacteremia. Describe the antibiotic resistance rates of invasive SP isolates. Describe the serotype distribution of resistant SP isolates.
Key Points This was a two-year active, prospective, hospital-based surveillance study of IPD and pneumonia in children aged 28 days to <60 months presenting at 1 of 3 hospitals in Bangalore South Zone, India. The population under surveillance in and around the area was defined demographically and geographically to estimate pneumococcal disease rates. After obtaining the basic history from the suspected cases, a blood specimen was collected upon enrolment. Cerebrospinal fluid (CSF) was collected for culture with suspected meningitis. Specimens from other sterile sites (e.g. pleural fluid) were collected as per routine medical practice. All samples underwent bacterial culture at the local laboratory, according to standard methodology, for identification of pathogens and reported microbiologic results as per their standard operating procedures. SP isolates were sub-cultured and sent to the central laboratory for confirmation of identification, serotyping and susceptibility testing. A chest radiograph (CXR) was obtained for children with clinically suspected pneumonia. The study included children residing within the defined catchment area aged 28 days to ≤36 months with a measured temperature or history of measured temperature ≥39.0°C in 24 hours prior to screening, or clinical suspicion of pneumonia, meningitis, sepsis, or other IPD regardless of temperature; OR children aged >36 months to <60 months with clinical suspicion of pneumonia, meningitis, sepsis, or other IPD regardless of temperature.
Key Points A total of 5,249 subjects were enrolled into the study from the calculated at-risk population of 112,483 children aged between 28 days and <60 months who resided within the defined catchment area in Bangalore. Mean age was 19.8 months and 66.5% of subjects were aged 28 days to <24 months ( Table 1 ). Overall 17 children were diagnosed with IPD. Prior pneumococcal conjugate vaccination occurred in 0.3% of all enrolled subjects and none of the IPD cases. Hospitalization was required for 17.5% of the subjects enrolled and occurred more commonly in those aged <24 months
Key Points 17 subjects with IPD resulted in an overall estimated incidence rate for IPD of 15.11 per 100,000 children. Six of the 17 cases occurred in subjects aged 6 months to <12 months, resulting in an estimated incidence rate of 46.01 per 100,000 for this specific age group ( Table 2 ). Final IPD cases observed were pneumonia in 12 subjects, meningitis in 3 subjects, and bacteraemia in 2 subjects. The overall estimated incidence rates for pneumonia, meningitis, and bacteraemia were 10.67, 2.67, and 1.78 per 100,000 children, respectively
Key Points Overall, positive culture growth was obtained in 432 (8.2%) of the 5,249 enrolled subjects. Percentages of total growth were as follows: Salmonella sp . 60 (13.9%); Streptococcus pneumonia 27 (6.3%); Staphylococcus hominis 41(9.5%); Micrococcus sp . 32 (7.4%); Staphylococcus epidermidis 24 (5.6%); Staphylococcus aureus 19 (4.4%). SP was detected and serotype information obtained in 17 subjects (n=18 serotypes). In 1 subject isolates grown from CSF and blood were of 2 different serotypes (CSF=6A and blood=3). Distribution of the serotypes isolated is shown in Table 3 ; 6A and 5 were seen most frequently. The serotype coverage offered by PCV7, PCV10, and PCV13 was 27.77%, 55.55%, and 100%, respectively. Four of the 18 isolates were resistant to trimethoprim/sulfamethoxazole, 3 to erythromycin, and 1 to ceftriaxone. Antibiotic resistance was observed for serotypes 6A, 14, 1, 3, and 19A.
Key Points Overall, positive culture growth was obtained in 432 (8.2%) of the 5,249 enrolled subjects. Percentages of total growth were as follows: Salmonella sp . 60 (13.9%); Streptococcus pneumonia 27 (6.3%); Staphylococcus hominis 41(9.5%); Micrococcus sp . 32 (7.4%); Staphylococcus epidermidis 24 (5.6%); Staphylococcus aureus 19 (4.4%). SP was detected and serotype information obtained in 17 subjects (n=18 serotypes). In 1 subject isolates grown from CSF and blood were of 2 different serotypes (CSF=6A and blood=3). Distribution of the serotypes isolated is shown in Table 3 ; 6A and 5 were seen most frequently. The serotype coverage offered by PCV7, PCV10, and PCV13 was 27.77%, 55.55%, and 100%, respectively. Four of the 18 isolates were resistant to trimethoprim/sulfamethoxazole, 3 to erythromycin, and 1 to ceftriaxone. Antibiotic resistance was observed for serotypes 6A, 14, 1, 3, and 19A.
Key Points This is the first study documenting the prevalence of the emerging serotypes (3, 6A and 19A) in Indian context. Serotypes 3, 6A and 19A were responsible for 44.45% of the disease caused by SP and this is a big number. This also points towards a trend of increasing prevalence of these emerging serotypes. This study also documents the presence of serotypes 1 and 5 (both 27.78%). The sample size was small (n=18 isolates). Just compare to IBIS which was done over 4 years, and there also the sample size was 103 (children less than 5 years). It is very difficult to isolate, and culture SP. But looking at the results, the trend is evident. The serotypes covered by PCV13 are there in India The overall incidence of IPD was 15.11 per 100,000 children and this is a high number. The incidence is very high in the first year of life. This finding covers up for the limited sample size in this 1 year population. When it came to antibiotic resistance, four of the 18 isolates were resistant to trimethoprim/sulfamethoxazole, 3 to erythromycin, and 1 to ceftriaxone. Antibiotic resistance was observed for serotypes 6A, 14, 1, 3, and 19A. Observe here that antibiotic resistance has been seen with the 3 emerging serotypes (3, 6A, and 19A), thus justifying why these are included in PCV13 The highest incidence of clinical pneumonia and chest X-ray plus pneumonia was in children less than 6 months of age. This again supplements the findings from CHERG report and the Million Death Study (Pneumonia remains the leading cause of neonatal mortality in India). The study analysis is only for the first year only. We await the results of the 2 nd year
Key Points Recently there has been an increase in serotype 19A. In fact in USA, it represents 5% of all isolates and is the most common non vaccine serotype displaying penicillin resistance.
Key Points Before the PneumoNET study, the first report on 19A incidence in India came out in the ANSORP study done in 10 Asian countries. In fact the incidence of serotype 19A was high in India (13%) and the clone ST320 associated with multidrug resistance was present in 66.6% of isolates. This report clearly demonstrates the rising incidence of serotype 19A in the country.
Key Points With over a decade of use across the world, PCV7 has NOT ONLY demonstrated its effectiveness in reducing IPD, Pneumonia, OM BUT ALSO has played a vital role in decreasing NP carriage, Antibiotic resistance, and visits to health care professionals. Thus truly demonstrating cost-effectiveness
Key Points PCV7 has a proven efficacy and over the last decade has shown the real world effectiveness in reducing the burden of IPD, Pneumonia, OM, and nasopharyngeal carriage. Also it has demonstrated herd immunity
Key Points This slide provides an overview of some of the key serotypes not included in PREVENAR that cause pneumococcal disease worldwide.
Key Points At the request of WHO, PneumoADIP researchers at the Johns Hopkins University School of Medicine conducted an analysis of the estimated serotype distribution of ENI among children <5 years of age worldwide. 1 Every WHO region was represented in the analysis, which was comprised of data from 169 studies conducted from 1980 to 2007. 1 The data above show the estimated coverage of ENI in young children (<5 years of age) by each of 3 pneumococcal conjugate vaccines, according to WHO region. PCV13 has the potential to cover at least 73.9% of the ENI in young children worldwide. 2 References GAVI PneumoADIP. Baltimore, MD: Johns Hopkins School of Public Health. November 30, 2008. http://www.vaccineamc.org/files/TPP_codebook.pdf. Accessed September 7, 2009. Dinleyici E, et al. Expert Rev Vaccines. 2009;8:977-986.
Key Points PCV13 has been tested for immunogenicity and safety in different clinical programs in various countries of the world including India.
Key Points PCV13 is indicated for Normal Healthy Children. But the question always everybody asks is whether it has a role in high risk children. The MMWR 2011 recommendations now extend the use of PCV13 beyond 2 years. i.e. it can be used in children from 2-18 years of age in high risk children. PPV23 can then be used after PCV13 administration.
Key Points The IAP Immunization Guidebook 2011 also recommends that PPV23 should be administered after PCV among high risk children aged 2-18 years as mentioned in the slide. It is but apparent that pneumococcal disease is a serious problem and needs to be prevented
Key Points Which vaccine to use where? This is the questions most of us have in mind. The above table shows the differences between the two vaccines.
Key Points Pneumococcal disease is the #1 vaccine-preventable cause of death worldwide in children aged <5 years 1 Prevenar 13 offers the broadest coverage of pneumococcal serotypes available in a conjugated vaccine 2,3 Prevenar 13, built on the scientific foundation of Prevenar, includes 6 additional serotypes 4 Convenient transition to Prevenar 13 can be done at any point in the recommended vaccination schedule 4 A single dose of Prevenar 13 in children previously vaccinated with Prevenar provides protection against 6 additional serotypes 5 References WHO 2004 Global Immunization Data. http://www.who.int/immunization_monitoring/ data/GlobalImmunizationData.pdf. Accessed September 3, 2009. Dinleyici E, et al. Expert Rev Vaccines. 2009;8:977-986. GAVI Pneumococcal AMC TPP, Nov 2008. http://www.vaccineamc.org/files/TPP_codebook.pdf. Accessed September 3, 2009. Prevenar 13. Summary of Product Characteristics. Wyeth Pharmaceuticals. Data on file, Pfizer Inc.