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1 To view an archived recording of this presentation please click the following link: Please scroll down this file to view a copy of the slides from the session.

2 Helpful tips when viewing the recording: The default presentation format includes showing the event index. To close the events index, please click on the following icon and hit close If you prefer to view the presentation in full screen mode, please click on the following icon in the top right hand corner of the share screen PublicHealthOntario.ca

3 What s new with the flu - The Universal Influenza Vaccination Program and influenza vaccines for the influenza season Overview and update September 22, 2015

4 Outline Overview of the Universal Influenza Immunization Program (UIIP) Stacy Recalla, Nurse Consultant, Ministry of Health and Long Term Care Vaccines Included in the UIIP recommended uses and indications Bryna Warshawsky, Public Health Physician, Public Health Ontario Questions and Answers PublicHealthOntario.ca 4

5 Part 1: Overview of Ontario s UIIP Context and Background re: Ontario s UIIP History Program Objectives Program Delivery Ontario s 2015/16 UIIP Coordinated planning for the 2015/16 influenza season 2015/16 publicly funded influenza vaccines Next Steps re: implementation 5

6 Ontario s UIIP: Context and Overview Ontario was the first jurisdiction in North America to implement the Universal Influenza Immunization Program (UIIP), which offers influenza vaccine free of charge each year to all persons six months of age and older who live, work or go to school in Ontario. 6

7 Objectives of the UIIP Launched in the fall of 2000 as part of the commitment to protect and promote the health of Ontarians, the UIIP aims to: Provide individual protection against influenza; Reduce the number and severity of influenza cases; Reduce the impact on the health care system during the influenza season; and Decrease the overall economic impact in both direct health care costs and indirect societal costs. 7

8 UIIP Program Delivery Key Components Annual application process for pharmacies and health care agencies Two-step process requiring a ministry-approved application and a public health unitapproved cold chain inspection Dissemination of UIIP Implementation Package Each year, the Ministry distributes UIIP implementation packages for all participating providers, which includes information on: Recommended influenza vaccine recipients Influenza vaccine supply Eligibility for specific influenza vaccines Information on vaccine ordering, including Vaccine Order Forms Information on reporting vaccine administration Distribution of Flu Vaccine The ministry usually begins distributing influenza vaccine to public health units (PHUs) in mid-late September. Providers generally start receiving vaccine about a week later, with high risk groups being the first priority for immunization. 8

9 UIIP Program Delivery (continued) Important role of public health units PHUs are instrumental in managing the UIIP at the local level, including conducting annual cold chain inspections, vaccine distribution to local providers, as well as conducting their own influenza immunization clinics. Flu vaccine clinics / settings Influenza vaccine is available through primary care providers, public health unit clinics, pharmacies, and in various other settings such as long-term care homes, workplaces, hospitals and community health centres. Communications The Ministry s Communications and Marketing Division (CMD) supports the UIIP rollout each year with a comprehensive communications plan. In addition, the ministry hosts an application during flu season where Ontarians can visit and use the Flu Vaccine Locator Tool to find an influenza immunization clinic nearby. 9

10 UIIP Program Delivery - Pharmacies In 2012, the scope of practice for pharmacists was expanded to include administration of the influenza vaccine to Ontarians 5 years of age and older in accordance with the UIIP. Each year since this initiative began, the number of doses of publicly funded influenza vaccine administered by trained pharmacists has increased as follows: In 2012/13, approximately 250,000 doses were administered through approximately 620 participating pharmacies. In 2013/14, approximately 766,000 doses were administered through approximately 2000 participating pharmacies. In 2014/15, approximately 901,000 doses were administered through approximately 2400 participating pharmacies. Building on these successes, the ministry anticipates that this initiative will continue to increase Ontarians access to influenza vaccine with approximately 2,500 pharmacies participating this year. 10

11 Ontario s 2015/16 UIIP: Coordinated Planning Influenza planning at the provincial level involves a number of parties: Ministry of Health and Long-Term Care: Public Health Policy and Programs Branch (of Public Health Division) provincial management and oversight of UIIP; health care worker influenza immunization Emergency Management Branch (of Public Health Division) - monitoring of influenza activity and planning for health system impacts and contingencies related to influenza Communications and Marketing Division influenza-related communications campaigns and material Public Health Ontario: scientific and technical support related to all influenza program activities; influenza surveillance and vaccine effectiveness analysis; publishing respiratory pathogen surveillance reports. To ensure a coordinated approach, a provincial influenza planning group chaired by PHD meets bi-weekly, with representation from all of the above areas. 11

12 2015/16 Publicly Funded Flu Vaccines (TIV) Vaccine Formulation Agriflu / Fluviral Influvac Fluad Trivalent inactivated vaccine (TIV) Trivalent inactivated vaccine (TIV) Trivalent inactivated vaccine (adjuvanted) (TIV-adjuvanted) Dosage 0.5mL 0.5mL 0.5mL Route of Administration Intramuscular Injection Intramuscular Injection Intramuscular Injection Eligibility 6 months and older* 18 years and older 65 years and older who reside in LTCH Potential Allergens Agriflu: Fluviral: Egg protein^ Egg protein^ Kanamycin Thimerosal Neomycin Thimerosal Egg protein^ Chicken protein Gentamicin Egg protein^ Chicken protein Kanamycin Neomycin Package Description Multi-dose vial Single dose syringe Single dose syringe Once punctured, discard vial after Package Dimensions L x W x H 28 days n/a n/a 3cm x 3cm x 7cm 18.8cm x 15.2cm x 1.7cm 10.8cm x 10.2cm x 4.4cm 12

13 2015/16 Publicly Funded Flu Vaccines (QIV) Vaccine Formulation Dosage Route of Administration Eligibility FluLaval Tetra / Fluzone Quadrivalent Quadrivalent inactivated vaccine (QIV) 0.5mL Intramuscular Injection 6 months through 17 years Potential Allergens FluLaval: Fluzone: Egg protein^ Thimerosal Egg protein ^ Thimerosal Package Description Once punctured, discard vial after Package Dimensions LxWxH Multi-dose vial FluLaval: Fluzone: 28 days expiry date indicated on vial 3cm x 3cm x 6cm 13

14 Influenza Vaccines for Specific Age Groups: Age Group 6 months through 17 years Recommended Vaccine QIV Alternative Vaccine TIV (if requested or if QIV is not available) 18 years and older TIV None 65 years and older who reside in LTCH TIV-adjuvanted TIV (if requested or if TIVadjuvanted is not available) Only Agriflu and Fluviral can be used to immunize individuals less than 18 years of age. 14

15 2015/16 UIIP: Next Steps Flu Vaccine Supply and Distribution Distribution of influenza vaccine is always intermittent, as each province and territory receives their influenza vaccine supply over a number of shipments. The Ministry anticipates that the first shipments of flu vaccine will be distributed from the provincial warehouse to public health units next week, for further distribution to local providers. UIIP Implementation Package The expected timing for release of these packages for the 2015/16 season is early October. 15

16 Acknowledgements Members of the UIIP Coordinated Planning Group: Dianne Alexander, MOHLTC Thomas Appleyard, MOHLTC Lucia De Stefano, MOHLTC Melissa Helferty, MOHLTC Amir Kahnamouee, MOHLTC Emily Karas, PHO Sarah Levitt, MOHLTC Tsui Scott, MOHLTC Brixhilda Shedollari, MOHLTC Dr. Bryna Warshawsky, PHO Anne Winter, PHO Janet Wong, PHO 16

17 Part 2: Overview of 2015/16 Flu Vaccines To provide an overview of: The influenza season and possibilities for the season The publicly-funded influenza vaccines included in the Universal Influenza Immunization Program Issues related to repeat vaccination Objectives PublicHealthOntario.ca 17

18 Outline Background concepts influenza season and implications for season Quadrivalent vaccine Use Why a quadrivalent vaccine? Why the age recommendations? Adjuvanted influenza vaccine Repeat vaccination PublicHealthOntario.ca 18

19 Immunogenicity Immune response to the vaccine May be related to how well it works or how long it lasts, but often don t know for sure Efficacy How well the vaccine works in a clinical trial Preferred method for vaccine authorization Effectiveness How well the vaccine works in real life Determined each year using the test negative casecontrol design Terms PublicHealthOntario.ca 19

20 Sentinel Practitioner Surveillance Network Effectiveness Eligible patients presenting to health care providers with influenza-like symptoms during influenza season are swabbed Influenza Positive Influenza Negative % vaccinated % vaccinated lower higher VE = (1-OR) X 100% PublicHealthOntario.ca 20

21 Season Influenza A/H1N1 Influenza vaccine effectiveness Canada, to seasons Influenza A/H3N2 Influenza B Overall % 57% 55% 60% % 55% 56% 56% * 93% % % 39% 25% 37% % 51% 51% 59% % 41% 68% 50% % - 73% (Yamagata) ** - -8% % PublicHealthOntario.ca * Influenza H1N1 Pandemic ** Mid-season results for A/H3N2 only 21

22 12,000 Total Influenza A and B by Year Ontario, to ,000 8,000 6,000 4,000 Influenza A Influenza B 2, season only includes cases reported up to the end of Week 28 (July 12, 2014) includes cases reported to the end of Week 18 (May 9, 2015) Counts from are underreported and should be interpreted with caution due to modified reporting during the pandemic data do not include approximately 1,200 cases in total for weeks 52, 53 and 1 as they were not reported through iphis. Source: Ontario Ministry of Health and Long-Term Care, integrated Public Health Information System (iphis) database, extracted by Public Health Ontario [2014/07/15] data from the Ontario Respiratory Virus Bulletin; Week 18 (May 3 to 9, Accessed September 13, 2015

23 Influenza Outbreaks, Hospitalizations and Deaths Ontario, ,101 3,698 4, Predominant type / subtype H3N H1N1 and B H3N Outbreaks Hospitalizations Deaths Sources: Week 19 Ontario Respiratory Virus Bulletin (ORVB); and Respiratory Virus Seasonal Summaries; Week 18 ORVB. Notes: Death data may be missing for as some cases were not entered in iphis. 410 hospitalizations not entered in iphis in added to figure shown; Deaths and hospitalizations likely to be underestimates; Changes occurred in reporting practices in that may affect comparisons to prior years

24 Match Poor vaccine effectiveness reflects the fact that the circulating strain and vaccine strain were not well matched Measure match by comparing: Antigenic properties (hemagglutination inhibition test) Genetic sequencing Because of troubles with the hemagglutination inhibition test in , more reliance on genetic sequencing PublicHealthOntario.ca 24

25 Phylogenetic Tree for H3N C.2a Predominant strain A/Switzerland 3C.3a A/Texas 3C.1 Skowronski PublicHealthOntario.ca et al. Eurosurveillance (Accessed September 15, 2015) 25

26 Influenza vaccine composition A/Texas/50/2012(H3N2) A/California/7/2009 (H1N1)pdm09 B/Massachusetts/2/2012 (Yamagata lineage) A/Switzerland/ / 2013(H3N2) A/California/7/2009 (H1N1)pdm09 B/Phuket/3073/2013 (Yamagata lineage) Quadrivalent B/Brisbane/60/2008 (Victoria lineage) PublicHealthOntario.ca Quadrivalent B/Brisbane/60/2008 (Victoria lineage) 26

27 Season Temperate countries in the Southern Hemisphere May 24 September 5, 2015 Australia and New Zealand B and H3N2 (B > H3N2), with small numbers of ph1n1 South Africa H3N2 and ph1n1 with some B South America A > B Chile and Paraguay ph1n1 and H3N2 Argentina H3N2 MMWR September 18, PublicHealthOntario.ca 27

28 Season Viruses tested by CDC from May 24 to Sep 5, viruses tested (58 international, 141 US) 10% ph1n1 - antigenically similar to vaccine strain 59% H3N2 antigenically or genetic group similar to vaccine strain 18% B/Yamagata antigenically similar to vaccine strain 13% B/Victoria antigenically similar to quadrivalent vaccine strain MMWR September 18, PublicHealthOntario.ca 28

29 Season Difference between WHO recommended strain Actual strain used to make the vaccine (egg-adapted, high growth reassortant) which may acquire additional mutations CDC assesses vaccine effectiveness against WHO recommended strains Concern that egg-adapted A/Switzerland strain in the vaccine does not protect well against circulating H3N2 C3.2a viruses based on: ECDC testing using egg-passaged A/Switzerland Low vaccine effectiveness against H3N2 C3.2a viruses preliminarily reported from Australia ECDC Influenza virus characterisation July 2015 PublicHealthOntario.ca 29

30 Implications for Could be any of many possibilities: Mild season H3N2 matched or mismatched season ph1n1 season B season with Yamagata, Victoria or both Any combination of the above Impossible to predict with any accuracy PublicHealthOntario.ca 30

31 Quadrivalent inactivated influenza vaccines

32 Quadrivalent inactivated vaccine Background Contains H3N2 and pandemic H1N1, and 2 influenza B strains B/Victoria lineage B/Yamagata lineage Authorized for the season First year in the publicly-funded program Two products: Fluzone Quadrivalent (Sanofi Pasteur) Fluval Tetra (GlaxoSmithKline) PublicHealthOntario.ca 32

33 Quadrivalent inactivated vaccine Background Similar immunogenicity to trivalent vaccine except greater immune response against the extra B strain However, even for the trivalent vaccine there is some degree of cross-protection across lineages Similar safety profile as the trivalent vaccine Similar use as trivalent vaccine 0.5 ml regardless of age Two doses if 6 months to < 9 years and not previously vaccinated against influenza Safe to use in pregnancy, immunocompromised Safe to use in egg allergic individuals PublicHealthOntario.ca 33

34 PublicHealthOntario.ca Quadrivalent inactivated vaccine Age recommendation NACI recommends quadrivalent vaccine for 6 months to < 18 years Age Ontario s Universal Influenza Immunization Program (UIIP) includes quadrivalent inactivated vaccine for children and adolescents (6 months to < 18 years) Recommended product 6 months to < 2 years Inactivated quadrivalent vaccine 2 to < 6 years Live attenuated quadrivalent vaccine preferred 6 years to < 18 years Inactivated quadrivalent or live attenuated vaccine NACI, Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for , July

35 Why a quadrivalent vaccine?

36 12,000 Total Influenza A and B by Year Ontario to ,000 8,000 6,000 Influenza A Influenza B 4,000 2, season only includes cases reported up to the end of Week 28 (July 12, 2014) includes cases reported to the end of Week 18 (May 9, 2015) Counts from are underreported and should be interpreted with caution due to modified reporting during the pandemic data do not include approximately 1,200 cases in total for weeks 52, 53 and 1 as they were not reported through iphis. Source: Ontario Ministry of Health and Long-Term Care, integrated Public Health Information System (iphis) database, extracted by Public Health Ontario [2014/07/15] data from the Ontario Respiratory Virus Bulletin; Week 18 (May 3 to 9, (Accessed September 13, 2015)

37 Influenza B by Year Ontario, to Doesn't match vaccine Matches vaccine V Y Y V V Y V V V Y Y Y Lineage in vaccine See previous slide for data sources Estimated based on applying distribution of Ontario influenza B strains tested by NML to total laboratory confirmed influenza B strains from iphis 37

38 On average over past seasons: Why a quadrivalent vaccine? ~17 to 25% of influenza cases are B 23% in Ontario over 11 seasons (excluding ) ~40% of the influenza B cases are lineage mismatched ~35% in Ontario over 11 seasons (excluding ) ~10% of influenza cases are lineage mismatched B ~ 8% in Ontario over 11 seasons (excluding ) Ambrose CS. Levin MJ Human Vaccines and Immunotherapeutics 2012: 8(1):81-8 Heikkinen T, et al. Clin Infect Dis 2014; 59: PublicHealthOntario.ca 38

39 Why the quadrivalent influenza vaccine for children?

40 Quadrivalent vaccine for children Higher rates of influenza B in children than adults Study over 10 years of sentinel practitioners in France 0-14 years 15+ years H3N2 49% 51% Pandemic H1N1 60% 40% B 63% 37% Mosnier A, et al. (2015) PLoS ONE 10(9): e doi: /journal.pone May be less cross protection from the trivalent vaccine in children Priming with both lineages may be beneficial for children PublicHealthOntario.ca 40

41 Adjuvanted Influenza Vaccine

42 Fluad (Novartis) Adjuvanted influenza vaccine Authorized in Canada in February 2011, but used in Europe since 1997 MF59 (squalene based, oil-in-water emulsion) Trivalent Authorized for those 65 years of age and over More immunogenic than unadjuvanted vaccine Uncertain whether more effective More local reactions; the same or more systemic reactions; mild and transient NACI Supplemental Statement on MF59 adjuvanted vaccine (Accessed September 15, 2015) PublicHealthOntario.ca 42

43 Adjuvanted influenza vaccine NACI No preferential recommendation Ontario recommendation Primarily available for those 65 years of age and over who live in long term care facilities PublicHealthOntario.ca 43

44 Repeat Vaccination

45 McLean et al McLean HQ et al. Impact of Repeated Vaccination on Vaccine Effectiveness Against Influenza A(H3N2) and B During 8 Seasons. Clinical Infectious Diseases September 29, , 315 encounters of people ( 9 years of age) swabbed for influenza over 8 seasons in Marshfield, Wisconsin; vaccine effectiveness using test negative design 2 analyses of vaccine effectiveness: 1. Vaccination status over two seasons 2. Vaccinated in current season and vaccination history over preceding five seasons PublicHealthOntario.ca 45

46 Analysis 1: Vaccination status over two seasons Compared vaccine effectiveness in those: Vaccinated in both current and previous season Vaccinated in current season only Vaccinated in previous season only Vaccinated in neither season (reference group) Similar vaccine effectiveness across all groups compared to reference group for both influenza A/H3N2 and B PublicHealthOntario.ca 46

47 Analysis 2: Vaccination over preceding five years Compared vaccine effectiveness in those: Vaccinated in current year and 4 or 5 of preceding years (frequent vaccinees) Vaccinated in current year and 1 to 3 of preceding years (infrequent vaccinees) Vaccinated in current season and none of preceding 5 years (non-vaccinees) Not vaccinated in current year or preceding 5 years (reference) PublicHealthOntario.ca 47

48 Vaccination over preceding five years Compared to reference group (not vaccinated in current or preceding 5 years) and after adjusting for several factors, vaccine effectiveness highest in those vaccinated only in the current season Vaccinated in: H3N2 B Only current year and not preceding 5 years (non-vaccinees) 65% (36 80) 75% (50 87) Current and 1 to 3 preceding years (infrequent vaccinees) Current and 4 to 5 preceding years (frequent vaccinees) 35% (13 51) 24% (3 41) 67% (53 77) 48% (29 62) PublicHealthOntario.ca 48

49 Studies inconsistent 17 comparisons found in 10 studies that look at vaccination status over two seasons (including analysis 1 in McLean) Results vary but general order of vaccine effectiveness, highest to lowest: Vaccinated in current season only Vaccinated in both current and previous season Vaccinated in previous season only Vaccinated in neither season (reference group) Recent McLean study found ranking differed by age (Mclean HQ et al JID, May 2015;211: ) PublicHealthOntario.ca 49

50 PublicHealthOntario.ca General conclusions about repeat vaccination Results inconsistent between studies, but generally vaccine effectiveness highest if vaccinated only in current season, but still better to be vaccinated in both seasons than only previous season Uncertain if: A true finding Result of residual confounding in observational studies True finding Immune interference Residual confounding Uncontrolled differences between those repeatedly vaccinated and those who aren t, including past influenza illness exposure Needs further study 50

51 Acknowledgements Dianne Alexander, MOHLTC Dr. Jonathan Gubbay, PHO Emily Karas, PHO Sarah Levitt, MOHLTC Shilpa Raju, formerly PHO Stacy Recalla, MOHLTC Matt Root, PHO Dr. Danuta Skowronski, BCCDC Dr. Doug Sider, PHO Kristen Wheeler, PHO Michael Whelan, PHO Anne Winter, PHO PublicHealthOntario.ca 51

52 Appendix A: Endnotes 2015/16 Publicly Funded Flu Vaccines (TIV) - Slide 10: * Unless specifically requested the TIVs are primarily targeted to adults 18 years of age and older. ^ Egg allergy is not a contraindication to receiving inactivated influenza vaccines (see National Advisory Committee on Immunization Influenza Statement available at /16 Publicly Funded Flu Vaccines (QIV) Slide 11: ^ Egg allergy is not a contraindication to receiving inactivated influenza vaccines (see National Advisory Committee on Immunization Influenza Statement available at 52