Presentation on theme: "PREVENAR13 Emerging New Data & PMS India Report On PCV7"— Presentation transcript:
1 PREVENAR13 Emerging New Data & PMS India Report On PCV7 Dr. Gautam RambhadAssociate Director Medical Services24st December 2011
2 JOURNEY OF PREVENAR IN INDIA Prevenar (PCV7) was launched in June 2006DCGI – Request to conduct PMS studyPrevenar13India launch - July 2010Approved in 115 countries*Launched in 106 countries** As of Dec 2011
3 Extensive experience with PCV7 IPDUSA: 76% decrease in overall IPD (<5 years)USA: 100% decrease in vaccine-type IPD (<5 years)UK: 98% decrease in vaccine-type IPD (<2 years)Germany: 90% decrease in vaccine-type IPD (<2 years)Norway: 95% decrease of vaccine-type IPD (<5 years)Ireland: 84% decrease in vaccine-type IPD (<2 years)Belgium: 97% decrease in vaccine-type IPD (<5 years)Netherlands: 90% decrease in vaccine-type IPD (<2 years)PneumoniaUSA: 22% reduction in all-cause CAP hospitalizations (<1 year)USA: 39% reduction in all-cause CAP hospitalizations (<2 years)USA: 52% reduction in all-cause CAP hospitalizations (<2 years)UK: 22% reduction in empyema-related hospitalization (<15 years)Italy: 15.2% reduction in all-cause CAP hospitalizations (<2 years)AOMGreece: 48% reduction in pneumococcal AOM visits (<14 years)Greece: 38% reduction in overall AOM episodes (<14 years)USA: 42.7% reduction in ambulatory visits for AOM (<2 years)Sweden: 26% reduction in AOM episodes (<2 years)Italy: 36.4% reduction in vaccine-type AOM hospitalizations (<2 years)NP carriageNetherlands: 92% reduction in vaccine-type carriage (at 24 months)UK: 69% reduction in vaccine-type carriage (<4 years)These slides have been provided by Pfizer to HCPs for the purposes of medical education3
4 PREVENAR13 – Moving towards the Adult Franchise November 16, 2011Prevenar13 : US-FDA considers ‘protection of adults/elderly from IPD and non-bacteremic pneumococcal pneumonia to be a meaningful therapeutic benefit’over existing treatments‘122 September 2011Prevenar13: Active immunization for the prevention of IPD caused by Streptococcus pneumoniae in adults aged 50 years and older.2To date, over 50 nations have approved Prevenar 13 adult use - Thailand, Australia, Bolivia, Philippines and a host of European countries among them31. accessed on December 20, 20112. Summaries of positive opinion 22 September EMA/CHMP/763049/2011 accessed December 20, 20113. accessed Nov 20, 2011
5 Prevenar13 - Countries shifting back1 *Notably, the number of childhood IPD caused by serotype 3 has increased from one case in 2009 to six cases in Consequently, among children below 5 years of age, the proportion of IPD caused by serotypes covered by PCV7*, PCV10* and PCV13 were 70%, 70% and 100% in 2009 changed to 47%, 47% and 93% respectively in ,2Hong KongDecember 5, 2011The Northern Territory has notified around 2 cases of invasive pneumococcal disease caused by type 3, 6A and 19A per year in under 2 years old over the last 3 years.3AustraliaOCTOBER 1, 20111. SCVPD.2.3.MEMORANDUM, Department of Health, Australia, 30/08/2011, p.1 (Ref no.DF 2011/3616)
6 Prevenar13 - Countries shifting back2 Recently, both Ontario and Quebec announced they would publicly fund Prevenar13 as part of the childhood immunization program, largely because it protects against additional serotypes, notably 19A, not contained in either the 7-valent or the 10-valent vaccine.1CanadaNovember 17, 2010
7 The Real Life Experience PREVENAR13The Real Life Experience
8 ABC surveillance: early trends for reduction of IPD in children <2 years after Prevenar13 introductionUSAIPD3 + 1PCV13 in April 2010PCV13Incidence of IPD in children <2 years between 20062008 and 2010 (n=14,168)All serotypesPCV13 serotypesIncidence (cases per 100,00)*p<0.0001*PCV13 introducedPCV13 introduced*p<0.0001*References:Moore M et al. ICAAC Annual Meeting Presentation #G Abstract available at: [accessed October 2011]Among children <2 years old, rates of overall- and PCV13-serotype-related IPD were lower only in the fourth quarter of 2010No significant changes were identified in IPD rates among other age groupsIPD cases (isolation of pneumococcus from sterile sites) were identified through 10 Active Bacterial Core surveillance (ABCs) sites. Isolates were serotyped to identify those included in PCV13. Quarterly incidence of IPD (cases per 100,000) in 2010 was compared to 20062008 (2009, year of influenza pandemic, was excluded) .These slides have been provided by Pfizer to HCPs for the purposes of medical educationMoore M et al. ICAAC Annual Meeting Presentation #G1-538
9 Serotyped IPD isolates (1 July 2007 to 30 June 2011) USAIPDMulti-hospital study: early trends for reduction of IPD in children (all ages) after PCV13 introduction3 + 1PCV13 in April 2010PCV13Serotyped IPD isolates (1 July 2007 to 30 June 2011)All isolatesIsolates by serotypePCV13 introducedSerotype 19A 45% in 2010201136%References:Kaplan SL et al. IDSA Annual Meeting Presentation #LB-1. Abstract available at: . [accessed October 2011].Early trends indicate 36% reduction in IPD cases among 8 children's hospitals for the 12 months starting 4 months after the introduction of PCV1319A cases decreased by 45% in the same periodHospital-based observational study. Children (all ages) with IPD prospectively identified from 8 children’s hospitals in the US since IPD confirmed by a central laboratory. Serotype and antibiotic resistance were identified.These slides have been provided by Pfizer to HCPs for the purposes of medical educationKaplan SL et al. IDSA Annual Meeting Presentation #LB-1.9
10 PCV National ProgramsPCV7 / PCV13PCV13 / PCV10 *PCV10
11 USAIPDAlaska: reduction of IPD cases in children <5 years after Prevenar13 introduction3 + 1PCV13 in April 2010PCV13IPD occurrence in children <5 yearsAlaskan Native childrenNon-Alaskan Native childrenP=0.003P=0.01P=0.5Incidence rate per 100,00071%100%References:Bruce M et al. IDSA Annual Meeting Poster #656. Abstract available at: . [accessed October 2011]P=0.02P=0.004P=0.9 [NS]A decrease was noted in non-PCV13 disease among Alaska native childrenState-wide birth cohort study involving the population of children <5. Pneumococcal isolates obtained from sterile sites and reported to Alaska-wide laboratory based surveillance sites. *April 2009–March 2010 was excluded because PCV13 was introduced pre-licensure in one high-risk region in Vaccine coverage in April 2011 was 90%, including 2,551 children who were vaccinated during the period AprDec 2010.These slides have been provided by Pfizer to HCPs for the purposes of medical educationBruce M et al. IDSA Annual Meeting Poster #656.
12 Ohio: reduction in overall IPD, all ages USAIPD3 + 1PCV13 in April 2010PCV13IPD incidence (all serotypes, 19A highlighted)Many of the strains between 2003 and 2009 (43.449.1%) have been from the 6 additional serotypes now included in PCV13Most of these being serotype 19A, followed by serotypes 3 and 7FAlthough PCV13 was introduced only very recently, there has been a dramatic decrease in 2010 in the number of pneumococci isolated overall and in the proportion of serotype19A strainsPCV7PCV13References:Jacobs MR et al. ICAAC Annual Meeting Presentation #G Abstract available at: [accessed October 2011].Observational study. Isolates were sequentially collected. S. pneumoniae isolated in the clinical microbiology laboratory, 19992010. Serotyping was performed by capsular swelling using commercial antisera.These slides have been provided by Pfizer to HCPs for the purposes of medical educationJacobs MR et al. ICAAC Annual Meeting Presentation #G3-773.
13 Six additional serotypes in Prevenar 13 but not in PCV7 UK: early trend for reduction of IPD in children <2 years after Prevenar13 introductionUKIPD2 + 1PCV13 in 2010PCV13Cumulative weekly number of IPD reports in children <2 Years in England and Wales by epidemiological yearPCV7 serotypesSix additional serotypes in Prevenar 13 but not in PCV7References:[accessed 18th November 2011].One year after PCV13 introduced in children <2 years:Maintained reduction of PCV7 types IPDDecreased number of reported cases of IPD related to 6 additional types included in PCV13 (particularly 19A and 7F types)Note: The above graph is based on week of isolation, therefore numbers for most recent weeks may not be complete. Numbers of reports of serotyped cases shown in the graph are not adjusted to account for any change that may have occurred over time and between age groups in the proportion of all IPD cases that are serotyped. The 7-valent conjugate vaccine was introduced into the childhood immunization schedule on the 4 September 2006, which corresponds with week 36 above.These slides have been provided by Pfizer to HCPs for the purposes of medical education. Accessed 18th November 2011.
14 UKIPDSignificant reduction of IPD caused by additional Prevenar13 serotypes in children <2 years2 + 1PCV13 in 2010PCV131, 3, 5, 6A, 6C combinedWithin one year of PCV13 introduction, IPD cases in children <2 years due to additional PCV13 serotypes were halvedSignificant reduction of 7F and 19A reported IPD cases7FReferences:Miller E et al. Vaccine 2011 Oct 5. ePub ahead of print.19AStudy population: children who were eligible for PCV13 (one or more doses) who reported to the Health Protection Agency with IPD (n=235) and had a complete vaccine history taken. IPD defined as isolation of S. pneumoniae from a normally sterile site. PCV13 was introduced nationally in week 13, 2010.These slides have been provided by Pfizer to HCPs for the purposes of medical educationMiller E et al. Vaccine 2011 Oct 5. ePub ahead of print.
15 Reduction in IPD caused by additional serotypes contained in PCV10 and Prevenar13 in children <2 yearsGERIPD3 + 1PCV13 in Dec PCV10 in Apr 2009PCV13Cumulative number of 6 additional PCV13 serotypes isolated from children <2 years with IPDOne year after the introduction of higher valent PCVs first effects are visible, with less reported cases among children <2 years due to serotypes 1, 3, 6A and 7FReferences:Van der Linden M et al. ICAAC Annual Meeting Presentation #G Abstract available at: [accessed October 2011]National observational study. Data taken from the German National Reference Center for Streptococci (GNRCS) from children <16 years of age with confirmed IPD between 1997 and Surveillance was passive and taken from diagnostic laboratories located nationwide.These slides have been provided by Pfizer to HCPs for the purposes of medical educationPCV10 & PCV 13 are currently available in GermanyIntroduction of PCV10 in April 2009 & PCV13 in Dec 2009.Van der Linden M et al. ICAAC Annual Meeting Presentation #G3-775.
16 PCV13PneumoniaReduction in Hospitalization Rates for Pneumonia with Prevenar13 in children < 2 yearsHospitalization Rates for Bacterial Pneumoniain Children < 2 years of ageHospitalization Rates for Pneumococcal Empyema In Children < 2 years of agePCV 7PCV 7PCV 13PCV 132010 vs79.0%47.4%WHO defined Radiological Pneumonia:↓ post PCV13 introductionPirez MC et al. SLIPE, May 2011, Punta Cana, Dominican Republic
17 NPC rates (%); children Significant reduction of NP carriage of 6 additional Prevenar13 serotypes in children <1 yearUSANPC3 + 1PCV13 in April 2010PCV13NPC rates (%); childrenp=0.002p=NSAge <12 monthsDecline in vaccine-type carriage prevalence observed for the 6 additional vaccine serotypes in children <12 months, but not in children 1259 monthsAge 1259 monthsReferences:Hsu K et al. IDSA Annual Meeting Poster #666. Abstract available at: [Accessed October 2011]This study was conducted in children < 5 yo.SP was recovered from 212 (22.9%). Between 2007 and 2011, in children < 12 months of age, pneumococcal carriage prevalence was comparable (21.7 per 100 vs per 100), however overall carriage of a PCV 13 serotypes (1, 3, 5, 6A, 7F, 19A) declined in 2011 from 7.3/100 to 1.3/ 100 [P=0.002]. In children 12 though 59 months of age, pneumococcal carriage increased in 2011 from 23.8/100 to 30.2/100 (P=0.01) but no difference in carriage of the 6 additional serotypes in PCV13 was observed (4.4/100 vs 4.9/100). A reduction in carriage prevalence of serotypes 6A and 7F (P=0.06 and 0.12 respectively) was observed in children 0 through 59 months of age but no change in carriage of 19A is evident to date.A non-statistically significant decline in carriage of serotypes 6A and 7F in children 0 through 59 months, was observed. But no change in 19A carriage for children 0-59 mo foundp=0.01p=NSObservational study. Nasopharyngeal surveillance was performed in children <60 months of age attending the primary care center (PCC) at Boston Medical Center. NP cultures were collected after obtaining informed consent and processed by routine microbiologic methods.These slides have been provided by Pfizer to HCPs for the purposes of medical educationHsu K et al. IDSA Annual Meeting Abstract. #66617
18 Early, widespread evidence of a positive PCV13 impact at a global level IPD: Alaska, USAIPD: ABC, USAIPD: HPA, UKPneumonia: UruguayIPD: GermanyIPD: USACarriage: FranceIPD: Ohio, USACarriage: Boston, USAEarly evidence needs to be confirmed by continuous surveillanceThese slides have been provided by Pfizer to HCPs for the purposes of medical education
20 PREVENAR PMS INDIA Study Objective Study Design To collect safety and tolerance data on PREVENAR for primary immunization and catch-up populationStudy DesignOpen-label, multi-center, non-comparative, prospective phase IV post-marketing observational studyA total of 161 investigators recruited 1094 children into the study
21 PREVENAR PMS INDIA Inclusion Criteria Inclusion Criteria For Primary Immunization Schedule:Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccinationFor Catch-up Immunization Schedule:Healthy male or female subjects months of age
22 PREVENAR PMS INDIA Exclusion Criteria Known or suspected history of Streptococcus pneumoniae diseasePrevious anaphylactic or other severe vaccine-associated adverse eventKnown or suspected impairment of immune system (including HIV infection)Recipient of immunosuppressive agents or those with a major congenital, developmental or serious chronic disorderConfirmed or suspected underlying evolving neurological disorder or history of seizuresHistory of thrombocytopenia or any coagulation disorderAcute illness at the time of vaccine administration
23 PREVENAR PMS INDIA Study Procedure Primary Immunization Schedule: Dose 1(6 weeks +5 days)Dose 2*(10 weeks + 5 days)Dose 3*(14 weeks + 5 days)6 weeks onwardsX* Minimum 4 week separation between vaccine administrationsCatch-up Immunization Schedule:Dose 2Dose 3From 12 – 23 months of ageConcomitant vaccine administration allowed in other extremity
24 PREVENAR PMS INDIA Safety Evaluation Subject observed for 30 minutes post vaccinationAE was documented in CRF and the subject followed until all untoward reactions resolvedParents or guardians were advised to report local and/or systemic events post-vaccination and reportSerious AE reported within 24 hours to Medical Department, Wyeth Limited
27 Total Incidences of Adverse Events PREVENAR PMS INDIATotal Incidences of Adverse EventsPrimaryCatch UpTotal
28 Adverse Events: Primary Series & Catch up PREVENAR PMS INDIAAdverse Events: Primary Series & Catch upDose 1Dose 2Dose 3Catch Up
29 Injection Site Adverse Events PREVENAR PMS INDIAInjection Site Adverse Events
30 PREVENAR PMS INDIA Completion Status Data represented as [N, (%)] Primary(n=810)Catch-up(n=284)Dose 1Dose 2Dose 3Children administered PREVENAR810804803284No. of children who completed the study (N, %)803 (99.13)284 (100)No. of early terminations from the study (N, %)7 (0.86)0 (0)Reasons for Early DiscontinuationLost to follow up (N, %)6 (87.5)Others (N, %)1 (12.5)Data represented as [N, (%)]
31 PREVENAR PMS INDIA Summary Most frequently reported AEs were pain/tenderness at injection site (9%) and fever (6.7%)AEs were not clinically significant and are in line with previous data1Lesser in incidence compared with AEs reported in Prevenar PIOther AEs noted (child lot fussier than usual, child lot sleepier than usual, child eating much more poorly than usual and injection site reactions) were transient, had < 2% incidenceIncidence of redness, swelling and a lump or hardness was much higher with concomitant vaccines compared to PREVENARThe incidence of pain and tenderness at the injection site was higher in the PREVENAR groupBlack S, et al Pediatr Infect Dis J 2000; 19(3):
32 Prevenar: Taking Pride in Healthy Babies PREVENAR PMS INDIAPrevenar: Taking Pride in Healthy BabiesPublication