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Efficacy differences between PCV10 and PCV13 - Slideset by Professors Esposito, Palmu, De Wals, Sanders

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This slideset edited by Professors Esposito, Palmu, De Wals and Sanders for the Second WAidid Congress present some studies that compare in different countries (including Finland, Sweden, Quebec and the Netherlands) efficacy differences between PCV10 and PCV13.

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Efficacy differences between PCV10 and PCV13 - Slideset by Professors Esposito, Palmu, De Wals, Sanders

  1. 1. Waidid CONSENSUS PAPER ON EFFICACY DIFFERENCES BETWEEN PCV10 AND PCV13 Susanna Esposito Pediatric Clinic, University of Perugia Perugia, Italy
  2. 2. PCV10 trial in Finland (FinIP) and the Finnish NVP Arto Palmu, MD, PhD, Research manager, head of Clinical Research Team, Department of Public Health Solutions
  3. 3. Disclosure • The National Institute for Health and Welfare (THL) has received research funding – from GlaxoSmithKline Biologicals SA for the Finnish Invasive Pneumococcal disease vaccine trial (FinIP), a nationwide effectiveness trial of the 10-valent PCV – From Pfizer for non-pneumococcal research • No outside support for NVP evaluation • A Palmu – Investigator in the studies 33.12.2018
  4. 4. Finnish Invasive Pneumococcal disease vaccine effectiveness trial (FinIP) ”Vaccine probe analysis re. pneumococcal disease burden”
  5. 5. Finnish Invasive Pneumococcal disease vaccine effectiveness trial design • Phase III/IV cluster-randomized, double-blind trial in children <19 months of age at enrolment • Cluster formation by geographical normal boundaries (N=78) • Vaccines – 10-valent PHiD-CV (GSK) in two thirds of clusters (N=52) OR – hepatitis B or A vaccine as control in one third of clusters (N=26) • GlaxoSmithKline as sponsor • Conducted nationwide 2009 to 2011, follow-up until 2018 • Over 47,000 children enrolled in total 5 Palmu et. al. Lancet 2013;381:214–22 3.12.2018
  6. 6. The disease burden caused by S. pneumoniae in infants and the vaccine preventable disease incidences (VPDI) Outcomes VE 3+1/2+1 95% CIs Incidence per 100 000 Control 3+1/2+1 VPDI per 100 000 Contribution of all VPDI reduction Contribution of all health care cost reduction IPD (invasive pneumococcal disease) 1 94% 77 to 99 80 75 0.6% 4.3% Non-laboratory-confirmed IPD 2 50% 32 to 63 422 207 1.5% 11.8% Pneumonia3 26% 8 to 41 1262 341 2.5% 13.9% Tympanostomy tube placement4 13% -2 to 26 7887 1100 8.1% 31.6% Antimicrobial purchases 5 8% 1 to 14 154900 11800 87.3% 38.4% 3.12.2018 6 VE, Vaccine Effectiveness; CI, Confidence Interval; VPDI, Vaccine-Preventable Disease Incidence; IPD, Invasive Pneumococcal Disease; AOM, Acute Otitis Media. Original data published:1Palmu et al. Lancet 2013, 2Palmu et al. Lancet Resp Med 2014, 3Kilpi et al. Vaccine2018, 4Palmu et al. Pediatr Inf Dis J 2015, 5Palmu et al. Lancet Inf Dis 2014
  7. 7. 3.12.2018 7 PCV in the National Vaccination Programme (NVP) • NVP started in Sep 2010 for children born June 2010 or later – 2+1 schedule: 3, 5, 12 mo of age – No catch-up, no previous PCV7 – Since 2009 for high-risk groups under 5 y of age • A public tender process: Synflorix™ (PCV10) selected – 70% based on price – 30% based on the additional serotypes in PCV13 (Quality criteria) • 2nd public tender process 2014: Synflorix™ (PCV10) selected – based on price only – Open process for criteria selection and discussion: http://en.opasnet.org/w/Tendering_process_for_pneumococcal_conjug ate_vaccine • 3rd public tender process opening soon
  8. 8. 3.12.2018 8 PCV in the National Vaccination Programme (NVP) • Coverage high based on national vaccination register 92 to 95% • Results on IPD available at the public website • THL.FI ”pneumococcal” • Published manuscripts – Jokinen et al PLoS One. 2015 – Palmu et al Pediatrics. 2015 – Palmu et al PLoS One. 2017 – Okasha et al Thorax. 2018 – Palmu et al Pediatr Infect Dis J. 2018 – Rinta-Kokko et al Vaccine. 2018 – Palmu et al Acta Paediatr. 2018 •
  9. 9. Experience in Sweden • Differences between countries but not between counties? • In Sweden, different counties use either PCV10 or PCV13 – Parallel (=at the same calendar time) comparison within one country! 3.12.2018 9
  10. 10. Experience in Sweden, Naucler et al CID2017 • The overall impact on IPD was similar between the vaccines, despite higher reduction in PCV13 counties for serotypes 6A and 19A (and 6C) • Similar results have also been reported for pneumonia and otitis • Note: Correction of the article published 09 October 2018 3.12.2018 10
  11. 11. Rationale for changes in the PCV program for children in Quebec 11 Philippe De Wals, MD, PhD Department of Social and Preventive Medicine, Laval University Quebec National Public Health Institute
  12. 12. 12 PCV Program in Quebec  October 2002: PCV7 offered to high-risk infants (3+1 doses) and children  5 years.  December 2004: PCV7 offered to all infants (2+1doses) + catch-up for children  5 years  June 2009: switch from PCV7 to PCV10 (no catch-up)  January 2011: switch from PCV10 to PCV13 (no catch-up)  September 2018: switch from PCV13 to PCV10
  13. 13. Incidence rate of invasive pneumococcal disease (per 100 000 person-years) among individuals less than 5 years of age in Quebec, 2000-2016 13 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 PCV13 types Other types Total PCV7 PCV10 PCV13 Incidence rate of invasive pneumococcal disease (per 100 000 person-years) among individuals less than 5 years of age in Quebec, 2000-2016 4 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 PCV13 types Other types Total PCV7 PCV10 PCV13 Overall IPD rate reduction = 86%
  14. 14. Incidence rate of invasive pneumococcal disease (per 100 000 person-years) among individuals > 5 years of age in Quebec, 2000-2016 14 PCV7 PCV10 PCV13 0 5 10 15 20 25 30 35 40 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 PCV13 types Other types Total Overall IPD rate reduction = nope
  15. 15. PCV effectiveness against serotype 19A IPD, Case-control study in Quebec, 2005-2016 15 Deceuninck et al. Poster 0300 ISPPD PCV10 PCV13 PCV 10+13 ≥ 1 dose 52% 61% - =2 doses 42% 33% 100% =3 doses 60% 83% 58% ≤365 days after last dose • ≥ 1 dose 73% 69% 82% >365 days after last dose • ≥ 1 dose -211% 23% 8%
  16. 16. 16  A 2+1 PCV13 schedule would be the most effective but also the most expensive option for IPD prevention  A mixed 2 PCV10 + 1 PCV13 schedule would be the most cost-effective option  A 2+10 schedule would be acceptable if a mixed schedule is impossible to negotiate
  17. 17. Seotype 19A IPD rates (per 100 000 p-y) among children less than 5 years of age in PCV10 and PCV10 countries in Sweden (Nauclair et al., CID 2017, corrected 2018) Counties Pre PCV10 or PCV13 Post PCV10 or PCV13 Difference/ 100 000 PCV10 0.7 1.1 0.4 PCV13 1.6 0.0 (1.6) PCV10 vs PCV13 2.0 17
  18. 18.  With a price differential of 25 CAD per dose between PCV10 and PCV13, a 2+1 PCV10 schedule would be more cost effective than a 2+1 PCV13 schedule in almost all plausible scenarios 18
  19. 19. References  Avis sur le calendrier optimal de vaccination des enfants contre les infections à pneumocoque au Québec:  https://www.inspq.qc.ca/publications/2334  Scientific advisory on the optimal schedule for childhood immunization against pneumococcal disease in Québec  https://www.inspq.qc.ca/en/publications/2379 19
  20. 20. PCV7 FOLLOWED BY PCV10: DUTCH DATA ON IPD AND PNEUMONIA Lieke Sanders The Neherlands
  21. 21. 18C PCV-7 CRM197 PCV-10 PD 4 4 6B 6B 9V 9V 14 14 18C 18C T 19F 19F D 23F 23F Pfizer 1 5 7F GSK • 2006: PCV-7 as 3+1 schedule No catch-up • 2011: PCV-10 (PHiD-CV), 3+1 schedule • 2013: PCV-10 as 2+1 schedule (2, 4 -11 months) • PPV23: restricted to high risk groups uptake <5% of ≥ 65+ years IPD in the Netherlands following PCV-7 and PHiD-CV10
  22. 22. IPD surveillance June 2004 - June 2018 • Sentinel laboratory surveillance – Nine sentinel labs – Covering 25% of the Netherlands • (population 17 million) • Positive isolates from blood and/or CSF • Hospitalized cases • Serotyped • Age, sex, date of material taken, hospital
  23. 23. IPD surveillance acoording to vaccine groups in The Netherlands, May 2004- May 2018 Children < 5 yrs 0.0 5.0 10.0 15.0 20.0 25.0 04-05 05-06 06-07 07-08 08-09 09-10 10-11 11-12 12-13 13-14 14-15 15-16 16-17 17-18 Pre Post-PCV7 Post-PCV10 Incidenceper100,000 Epidemiological year <5 years PCV7 PCV10 extra PCV13 extra nonPCV13 all M.Knol et al, 2018, unpublished 2004-2006 vs 2016-18 Overall impact -69%
  24. 24. 0.0 1.0 2.0 3.0 4.0 5.0 6.0 04-05 05-06 06-07 07-08 08-09 09-10 10-11 11-12 12-13 13-14 14-15 15-16 16-17 17-18 Pre Post-PCV7 Post-PCV10 Incidenceper100,000 Epidemiological year 5-49 years PCV7 PCV10 extra PCV13 extra nonPCV13 all IPD surveillance acoording to vaccine groups in The Netherlands, May 2004- May 2018 Age 5-49 yrs M.Knol et al, 2018, unpublished 2004-06 vs 2016-18 Overall impact -31%
  25. 25. 0 5 10 15 20 25 04-05 05-06 06-07 07-08 08-09 09-10 10-11 11-12 12-13 13-14 14-15 15-16 16-17 17-18 Pre Post-PCV7 Post-PCV10 Incidenceper100,000 Epidemiological year 50-64 years PCV7 PCV10 extra PCV13 extra nonPCV13 all 2004-06 vs 2016-18 Overall impact + 6% IPD surveillance acoording to vaccine groups in The Netherlands, May 2004- May 2018 Age 50-64 yrs M.Knol et al, 2018, unpublished
  26. 26. 0 10 20 30 40 50 60 70 04-05 05-06 06-07 07-08 08-09 09-10 10-11 11-12 12-13 13-14 14-15 15-16 16-17 17-18 Pre Post-PCV7 Post-PCV10 Incidenceper100,000 Epidemiological year 65+ years PCV7 PCV10-7 PCV13-10 non-PCV13 all serotypes 2004-06 vs 2016-18 Overall impact -19% IPD surveillance acoording to vaccine groups in The Netherlands, May 2004- May 2018 Age 65+ years M.Knol et al, 2018, unpublished
  27. 27. 0 10 20 30 40 50 60 70 04-05 05-06 06-07 07-08 08-09 09-10 10-11 11-12 12-13 13-14 14-15 15-16 16-17 17-18 Pre Post-PCV7 Post-PCV10 Incidenceper100,000 Epidemiological year 65+ years PCV7 PCV10-7 PCV13-10 non-PCV13 all serotypes Emerging serotypes 8, 12F, 9N 2004-06 vs 2016-18 Overall impact -19% IPD surveillance acoording to vaccine groups in The Netherlands, May 2004- May 2018 Age 65+ years M.Knol et al, 2018, unpublished Serotypes 19A and 3
  28. 28. Post-PCV10 IPD summary in the Netherlands • PCV7 followed by PCV-10 resulted in substantial reduction in IPD in • children <5 yrs (69%) • 18-49 yrs (31%) • 65+ yrs (19%) • After the switch from PCV7 to PCV10, a (non-significant) additional reduction in IPD was observed in childen < 5 yrs of age (RR 0.68, 0.42-1.11) • No additional reduction following PCV10 in older adults (50+ yrs) and elderly (65+ yrs) due to emergence of non PCV-13 serotypes • No additional reduction in IPD incidence across all ages was observed after the switch from PCV7 to PCV10 (2016-18 vs 2009-2011 RR 1.05, 95% CI 0.97-1.14)
  29. 29. Acknowledgements NRLBM, AMC/RIVM • Arie van der Ende RIVM • Mirjam Knol • Hester de Melker UMCU • Elisabeth Sanders • Krystof Trzcinski • Annemarie van Deursen Antonius Ziekenhuis • Gert Jan Wagenaar • Stefan Vestjens
  30. 30. WAidid Consensus Paper The impact of PCV10 and PCV13 on pneumococcal infections
  31. 31. Methods – Literature Search • Conducted using pre-defined keywords, also including useful suggestions received during and after the conference call • Conducted using PubMed/Medline and Web of Science • Search for additional (missed) articles by checking the lists of references, reviews, and Google Scholar findings
  32. 32. Methods – Search strings • In PubMed/Medline: (pneumococcal OR pneumococcus OR streptococcus pneumoniae) AND (pcv10 OR pcv13 OR pcv-10 OR pcv-13 OR phid-cv OR 13vpcv OR 10vpcv OR 10-valent OR 13-valent) • In WoS: TS=((pneumococcal OR pneumococcus OR streptococcus pneumoniae) AND (pcv10 OR pcv13 OR pcv-10 OR pcv-13 OR phid-cv OR 13vpcv OR 10vpcv OR 10-valent OR 13-valent)) • Limits: papers published from 2010 onwards
  33. 33. Methods – Search results • In PubMed/Medline: 1252 papers • In WoS: 1132 papers (Search period: February 2017) In a preliminary analysis, an important proportion (20- 25%) of those papers could include relevant data to the purpose of this investigation  Too wide: restrict the inclusion criteria and focus on the central question only
  34. 34. WAidid Consensus Paper – Main Aim (2) • Focus the investigation on the impact and effectiveness of PCV10 and PCV13 in children ≤5 years in the following conditions:  IPD  Pneumonia  Otitis media  Reference paper: de Oliveira et al, PlosOne 2016
  35. 35. Flow-chart for search & selection of relevant articles
  36. 36. Methods – Search results (2) • More than 10% of papers were maintained after 1st selection • About half of them were excluded after the 2nd (full-text) examination • A total of 81 papers reported data relevant to the investigation
  37. 37. Papers included (1) (continues) Claudio Pelucchi WAidid Consensus Paper meeting Rome, 6 April 2017 Disease-vaccine No. papers No. papers by country IPD-PCV10 14 (from 12 studies) 4 Canada 4 Finland (2 studies) 2 Brazil 1 each: Spain, Netherlands, Czech Republic, Chile IPD-PCV13 40 (from 39 studies) 10 USA 5 Spain 3 Canada, UK, Germany (2 studies) 2 South Africa, Taiwan, Italy 1 Australia, Uruguay, Gambia, Norway, Czech Republic, Denmark, Portugal, Israel, France, Sweden
  38. 38. Papers included (2) Claudio Pelucchi WAidid Consensus Paper meeting Rome, 6 April 2017 Disease-vaccine No. papers No. papers by country Pneumonia-PCV10 9 6 Brazil 2 Chile 1 Sweden Pneumonia-PCV13 18 (from 15 studies) 3 USA (2 studies), Sweden (2 studies) 2 Argentina, Scotland, France, Spain, Israel (1 study) 1 Nicaragua, Rwanda Otitis media-PCV10 2 1 each: Australia, Finland Otitis media-PCV13 4 (3 studies) 2 Israel (1 study) 1 each: UK, Australia
  39. 39. Figure 1 (a) Range: 2%-93%
  40. 40. Figure 1 (b) Range: -3%-89%
  41. 41. Figure 1 (c) Range: 22%-87%
  42. 42. Figure 2 (a) Range: 4%-56%
  43. 43. Figure 2 (b) Range: 1%-63%
  44. 44. Figure 3 (a) Range: 6%-42%
  45. 45. Figure 3 (b) Range: 6%-75%
  46. 46. Conclusions – (1) • Both PCV10 and PCV13 had a major impact against IPD in children ≤5 years • Effectiveness was comparable in studies/countries that adopted PCV10 and PCV13
  47. 47. Conclusions – (2) • Both PCV10 and PCV13 had an impact against pneumonia in children ≤5 years • The size of the impact was lower than for IPD • Effectiveness against pneumonia of PCV13 might be slightly higher than PCV10 – but the issue is difficult to ascertain
  48. 48. Conclusions – (3) • Few studies focused on otitis media, with heterogeneous results • Both PCV10 and PCV13 have an impact against OM in children ≤5 years • One study compared PCV10 and PCV13 effectiveness against OM, and found no significant difference
  49. 49. Conclusions – (4) • In general, results were highly heterogeneous between studies/countries, due to a number of factors such as:  Design and methods of the study  Periods examined (of PCV use and comparison period)  Age group considered

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