Presentation is loading. Please wait.

Presentation is loading. Please wait.

1 PREVENAR13 24 st December 2011 Dr. Gautam Rambhad Associate Director Medical Services Emerging New Data & PMS India Report On PCV7.

Similar presentations


Presentation on theme: "1 PREVENAR13 24 st December 2011 Dr. Gautam Rambhad Associate Director Medical Services Emerging New Data & PMS India Report On PCV7."— Presentation transcript:

1 1 PREVENAR13 24 st December 2011 Dr. Gautam Rambhad Associate Director Medical Services Emerging New Data & PMS India Report On PCV7

2 2 2 JOURNEY OF PREVENAR IN INDIA Prevenar (PCV7) was launched in June 2006 DCGI – Request to conduct PMS study Prevenar13 India launch - July 2010 Approved in 115 countries* Launched in 106 countries* * As of Dec 2011

3 3 These slides have been provided by Pfizer to HCPs for the purposes of medical education 3 Extensive experience with PCV7 IPD USA: 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) Pneumonia USA: 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) AOM Greece: 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 carriage Netherlands: 92% reduction in vaccine-type carriage (at 24 months) UK: 69% reduction in vaccine-type carriage (<4 years)

4 4 22 September 2011 Prevenar13: Active immunization for the prevention of IPD caused by Streptococcus pneumoniae in adults aged 50 years and older. 2 November 16, 2011 Prevenar13 : US-FDA considers protection of adults/elderly from IPD and non-bacteremic pneumococcal pneumonia to be a meaningful therapeutic benefitover existing treatments 1 1. http://www.medscape.com/viewarticle/753734_print accessed on December 20, 2011http://www.medscape.com/viewarticle/753734_print accessed on December 20 2. Summaries of positive opinion 22 September 2011 EMA/CHMP/763049/2011 accessed December 20, 2011 3. http://www.pharmaceutical-int.com/news/fda-panel-approves-prevnar-13-adult-use.html accessed Nov 20, 2011http://www.pharmaceutical-int.com/news/fda-panel-approves-prevnar-13-adult-use.html accessed Nov 20 PREVENAR13 – Moving towards the Adult Franchise To date, over 50 nations have approved Prevenar 13 adult use - Thailand, Australia, Bolivia, Philippines and a host of European countries among them 3

5 5 Prevenar13 - Countries shifting back 1 serotype 3 47%, 47% and 93% *Notably, the number of childhood IPD caused by serotype 3 has increased from one case in 2009 to six cases in 2010. 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 2010. 1,2 Hong Kong December 5, 2011 3, 6A and 19A The 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. 3 Australia OCTOBER 1, 2011 1. SCVPD. http://www.chp.gov.hk/files/pdf/recommendations_on_the_use_of_13valent_pneumococcal_conjugate_vaccine_in_cip.pdf 2. http://www.chp.gov.hk/en/view_content/24122.html 3.MEMORANDUM, Department of Health, Australia, 30/08/2011, p.1 (Ref no.DF 2011/3616)

6 6 19A 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. 1Canada November 17, 2010 Prevenar13 - Countries shifting back 2

7 7 PREVENAR13 The Real Life Experience

8 8 These slides have been provided by Pfizer to HCPs for the purposes of medical education 8 ABC surveillance: early trends for reduction of IPD in children <2 years after Prevenar13 introduction Moore M et al. ICAAC Annual Meeting 2011. Presentation #G1-538 All serotypesPCV13 serotypes *p<0.0001 * IPD 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 2006 2008 (2009, year of influenza pandemic, was excluded). Incidence of IPD in children <2 years between 2006 2008 and 2010 (n=14,168) Among children <2 years old, rates of overall- and PCV13-serotype-related IPD were lower only in the fourth quarter of 2010 No significant changes were identified in IPD rates among other age groups 3 + 1 PCV13 in April 2010 USA PCV13 introduced PCV13 IPD Incidence (cases per 100,00) *p<0.0001 *

9 9 These slides have been provided by Pfizer to HCPs for the purposes of medical education 9 Multi-hospital study: early trends for reduction of IPD in children (all ages) after PCV13 introduction Serotyped IPD isolates (1 July 2007 to 30 June 2011) Kaplan SL et al. IDSA Annual Meeting 2011. Presentation #LB-1. Serotype 19A 45% in 2010 2011 36% Isolates by serotypeAll isolates Hospital-based observational study. Children (all ages) with IPD prospectively identified from 8 childrens hospitals in the US since 1993. IPD confirmed by a central laboratory. Serotype and antibiotic resistance were identified. Early trends indicate 36% reduction in IPD cases among 8 children's hospitals for the 12 months starting 4 months after the introduction of PCV13 19A cases decreased by 45% in the same period 3 + 1 PCV13 in April 2010 USA PCV13 introduced PCV13 IPD

10 10 PCV National Programs PCV7 / PCV13 PCV13 / PCV10 * PCV10

11 11 These slides have been provided by Pfizer to HCPs for the purposes of medical education 11 Alaska: reduction of IPD cases in children <5 years after Prevenar13 introduction IPD occurrence in children <5 years Alaskan Native children Non-Alaskan Native children P=0.02P=0.004P=0.9 [NS] Bruce M et al. IDSA Annual Meeting 2011. Poster #656. P=0.003P=0.01P=0.5 Incidence rate per 100,000 71% 100% A decrease was noted in non-PCV13 disease among Alaska native children State-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 2009. Vaccine coverage in April 2011 was 90%, including 2,551 children who were vaccinated during the period Apr Dec 2010. 3 + 1 PCV13 in April 2010 USA PCV13 IPD

12 12 These slides have been provided by Pfizer to HCPs for the purposes of medical education 12 Jacobs MR et al. ICAAC Annual Meeting 2011. Presentation #G3-773. Ohio: reduction in overall IPD, all ages Observational study. Isolates were sequentially collected. S. pneumoniae isolated in the clinical microbiology laboratory, 1999 2010. Serotyping was performed by capsular swelling using commercial antisera. IPD incidence (all serotypes, 19A highlighted) PCV13PCV7 Many of the strains between 2003 and 2009 (43.4 49.1%) have been from the 6 additional serotypes now included in PCV13 Most of these being serotype 19A, followed by serotypes 3 and 7F Although 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 strains 3 + 1 PCV13 in April 2010 USA PCV13 IPD

13 13 These slides have been provided by Pfizer to HCPs for the purposes of medical education 13 http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/Pneumococcal/EpidemiologicalDataPneumococcal/CurrentEpidemiologyPneumococcal/InPrevenar7/. Accessed 18 th November 2011. Cumulative weekly number of IPD reports in children <2 Years in England and Wales by epidemiological year Six additional serotypes in Prevenar 13 but not in PCV7PCV7 serotypes UK: early trend for reduction of IPD in children <2 years after Prevenar13 introduction 2 + 1 PCV13 in 2010 UK One year after PCV13 introduced in children <2 years: Maintained reduction of PCV7 types IPD Decreased 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. PCV13 IPD

14 14 These slides have been provided by Pfizer to HCPs for the purposes of medical education 14 Significant reduction of IPD caused by additional Prevenar13 serotypes in children <2 years Within one year of PCV13 introduction, IPD cases in children <2 years due to additional PCV13 serotypes were halved Significant reduction of 7F and 19A reported IPD cases 2 + 1 PCV13 in 2010 Miller E et al. Vaccine 2011 Oct 5. ePub ahead of print. 7F 19A UK Study 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. 1, 3, 5, 6A, 6C combined PCV13 IPD

15 15 These slides have been provided by Pfizer to HCPs for the purposes of medical education 15 Reduction in IPD caused by additional serotypes contained in PCV10 and Prevenar13 in children <2 years Van der Linden M et al. ICAAC Annual Meeting 2011. Presentation #G3-775. PCV13 in Dec 2009 PCV10 in Apr 2009 3 + 1 Cumulative number of 6 additional PCV13 serotypes isolated from children <2 years with IPD GER 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 2011. Surveillance was passive and taken from diagnostic laboratories located nationwide. PCV10 & PCV 13 are currently available in Germany Introduction of PCV10 in April 2009 & PCV13 in Dec 2009. One 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 7F PCV13 IPD

16 16 PCV 7 Reduction in Hospitalization Rates for Pneumonia with Prevenar13 in children < 2 years 79.0% 47.4% PCV 13 PCV 7 PCV 13 Pirez MC et al. SLIPE, May 2011, Punta Cana, Dominican Republic Hospitalization Rates for Bacterial Pneumonia in Children < 2 years of age Hospitalization Rates for Pneumococcal Empyema In Children < 2 years of age 2010 vs. 2005-2007 WHO defined Radiological Pneumonia: post PCV13 introduction Pneumonia PCV13

17 17 These slides have been provided by Pfizer to HCPs for the purposes of medical education 17 NPC rates (%); children Age 12 59 months Significant reduction of NP carriage of 6 additional Prevenar13 serotypes in children <1 year Hsu K et al. IDSA Annual Meeting 2011. Abstract. #666 p=0.01 p=NS Observational 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. Decline in vaccine-type carriage prevalence observed for the 6 additional vaccine serotypes in children <12 months, but not in children 12 59 months NPC 3 + 1 PCV13 in April 2010 USA PCV13 p=0.002 p=NS Age <12 months

18 18 These slides have been provided by Pfizer to HCPs for the purposes of medical education 18 Early, widespread evidence of a positive PCV13 impact at a global level IPD: USA PCV13 IPD: ABC, USAIPD: Alaska, USA IPD: Ohio, USA Carriage: Boston, USA IPD: Germany Carriage: France IPD: HPA, UK Pneumonia: Uruguay Early evidence needs to be confirmed by continuous surveillance

19 19 PREVENAR The India PMS Study

20 20 Study Objective To collect safety and tolerance data on PREVENAR for primary immunization and catch-up population PREVENAR PMS INDIA Study Design Open-label, multi-center, non-comparative, prospective phase IV post-marketing observational study A total of 161 investigators recruited 1094 children into the study

21 21 Inclusion Criteria For Primary Immunization Schedule: Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination For Catch-up Immunization Schedule: Healthy male or female subjects 12-23 months of age PREVENAR PMS INDIA Inclusion Criteria

22 22 Exclusion Criteria Known or suspected history of Streptococcus pneumoniae disease Previous anaphylactic or other severe vaccine-associated adverse event Known or suspected impairment of immune system (including HIV infection) Recipient of immunosuppressive agents or those with a major congenital, developmental or serious chronic disorder Confirmed or suspected underlying evolving neurological disorder or history of seizures History of thrombocytopenia or any coagulation disorder Acute illness at the time of vaccine administration PREVENAR PMS INDIA

23 23 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 onwardsXXX * Minimum 4 week separation between vaccine administrations Catch-up Immunization Schedule:Dose 1Dose 2Dose 3 From 12 – 23 months of age X Concomitant vaccine administration allowed in other extremity PREVENAR PMS INDIA

24 24 Safety Evaluation Subject observed for 30 minutes post vaccination AE was documented in CRF and the subject followed until all untoward reactions resolved Parents or guardians were advised to report local and/or systemic events post-vaccination and report Serious AE reported within 24 hours to Medical Department, Wyeth Limited PREVENAR PMS INDIA

25 25 Demographics 1094 Children Boys (n=602; 55%) Girls (n=492;45%) Primary (n=810) Boys (n=437) 54% Girls (n=373) 46% Catch Up (n=284) Boys (n=165) 58.1% Girls (n=119) 41.9% PREVENAR PMS INDIA

26 26 PREVENAR PMS INDIA

27 27 Total Incidences of Adverse Events Primary Total Catch Up PREVENAR PMS INDIA

28 28 Adverse Events: Primary Series & Catch up Dose 1 Dose 2 Dose 3 Catch Up PREVENAR PMS INDIA

29 29 Injection Site Adverse Events PREVENAR PMS INDIA

30 30 Data represented as [N, (%)] Primary (n=810) Catch-up (n=284) Dose 1Dose 2Dose 3 Children administered PREVENAR810804803284 No. 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 Discontinuation Lost to follow up (N, %) 6 (87.5)0 (0) Others (N, %) 1 (12.5) Completion Status PREVENAR PMS INDIA

31 31 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 data 1 Lesser in incidence compared with AEs reported in Prevenar PI Black S, et al Pediatr Infect Dis J 2000; 19(3): 187-195. Summary PREVENAR PMS INDIA Other 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% incidence Incidence of redness, swelling and a lump or hardness was much higher with concomitant vaccines compared to PREVENAR The incidence of pain and tenderness at the injection site was higher in the PREVENAR group

32 32 Prevenar : Taking Pride in Healthy Babies PREVENAR PMS INDIA

33 33 MERRY XMAS & A HAPPY NEW YEAR 2012


Download ppt "1 PREVENAR13 24 st December 2011 Dr. Gautam Rambhad Associate Director Medical Services Emerging New Data & PMS India Report On PCV7."

Similar presentations


Ads by Google