Canadian National Vaccine Safety (CANVAS) Network

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1 Canadian National Vaccine Safety (CANVAS) Network Julie A. Bettinger Vaccine Evaluation Center, BC Children s Hospital University of British Columbia

2 Disclosure Statement Disclosure of Relationship I am a member of an Advisory Board or equivalent with a commercial organization. I am a member of a Speaker Bureau. I have received payment from a commercial organization (including gifts or other consideration or in kind compensation). I hold a patent for a product referred to in the CME/CPD program or that is marketing by a commercial organization I hold a patent for a product referred to in the CME/CPD program or that is marketing by a commercial organization I hold investments in a pharmaceutical organization, medical devices company or communications firms. I am currently participating in or have participated in a clinical trial within the past two years. Company/Organization Medicago N/A N/A N/A N/A N/A N/A

3 CANVAS: Vaccine Safety Surveillance Objective: To develop a feasible and inexpensive methodology capable of providing early safety data to public health authorities for seasonal influenza vaccines, pandemic influenza vaccine and other new vaccines (meningococcal B vaccine) in various age groups

4 CANVAS: Vaccine Safety Surveillance Developed a network of >20,000 participants Online survey at various time points to measure safety of seasonal influenza vaccines each year Includes control group of ~10,000 unvaccinated participants to enable background rate calculations for common events

5 Background Since 2009 web-based active safety surveillance of vaccinated health care workers across Canada : Online survey at day 8, day 29 and 6 months after immunization 2010: Online survey day 8 and day : Measured background rates for events. Control survey administered 7-14 days prior to influenza vaccination program start 2012: Added telephone follow up for non-responders. Pilot tested surveillance in parents of vaccinated children : Expanded to vaccinated adults and children 1. De Serres et al. Plos One;2012:7(7 e38563). 2. Bettinger et al. PIDJ 2014;33:

6 Background 2014: Surveillance in 5 provinces at 7 main sites BC, AB, QC, ON and NS 4 public health sub sites in Ontario and BC Pharmacies in ON, BC and NS Developed mobile safety application ( app ) which enables smart phone use Influenza safety surveillance adapted to monitor safety of meningococcal B vaccine program in Quebec

7 Methods Active recruitment at clinics Collect participant details at time of immunization Online registration (at clinic or home) Participant enters details via survey website

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9 Methods Online consent

10 Methods Background rates/control group Previous year s participants ed notice to start monitoring health ~2 weeks prior to vaccination programs Background health event survey ed Reminder Severe events followed up by telephone

11 Methods Severe health events: Cause work/school/daycare absenteeism Prevent daily activities Cause a health care visit

12 Methods Online survey collects information on local reactions, systemic symptoms, allergic symptoms and other health events

13 Methods Online survey collects information on local reactions, systemic symptoms, allergic symptoms and other health events

14 Methods: allergic symptoms and other health events

15 Methods Online reported Health Events or AEFI followed up by nurses for event details within hrs.

16 Methods If signal identified ability for additional enhanced follow up: existing consent

17

18 Signal Detection 2012 October 2012 Italian and Canadian authorities suspend Agriflu use CANVAS ONLY safety information on Agriflu vaccine available in Canada at that time First safety data available Oct. 22 Full analysis of safety information to PHAC by Oct Agriflu vaccinees, 1253 other influenza vacinees and 3260 unimmunized participants No safety signal detected Vaccine suspension lifted Oct. 30

19 Results 2013 Enrolled 21,669 vaccinees: 61% response rate (N=13,127) 1459 (11%) parents of children 6 months-16 years 11,668 adults Enrolled 13,622 controls: 50% response rate (N=6763) 855 (13%) parents of children 6 months-16 years 5,908 adults

20 CANVAS: Weekly Results Nov. 4, 2014 CONTROLS (non-vaccinated group) 7/7 sites have collected information on the nonvaccinated group (controls) 8476 responded to 8 day survey 7639 adults and 837 children 349 reported a severe health issue in last 7 days 4.1% background event rate 95.9% no events

21 CANVAS: Weekly Results Nov. 4, 2014 VACCINEES 10,920 vaccinated participants enrolled 7/7 sites enrolling 5/7 have reached 8 day reporting period on first group enrolled 1 site has completed enrollment 4454 responded to 8-day survey 193 reported a severe health issue in last 7 days 4.3% event rate 95.7% no events

22 CANVAS: 2014 What we can provide: Vaccinees Table 1: CANVAS AEFI Reported as of November 11, 2014 FPT AB BC ON NS QC Total AEFI Total Severe* Hospitali Febrile reported AEFIs zations ED Anaphylaxis Seizure Seizure ORS Vaccine type in ORS cases =agriflu; 1=flumist; 4=fluviral =agriflu =agriflu; 1=vaxigrip, 2=To be confirmed =agriflu total=7 agriflu; 1=flumist; 1=vaxigrip; 4=fluviral, 2=to be TOTAL confirmed *Severe defined as work/school absenteeism/prevent daily activities/seek health care 1 anaphylaxis case was given Fluviral

23 CANVAS: 2014 What we can provide: Controls Table 1: CANVAS AE Reported as of November 11, 2014 FPT AB BC ON NS QC Total AE Total Hospitaliza Febrile reported Severe* AE tions ED Anaphylaxis Seizure Seizure ORS TOTAL *Severe defined as work/school absenteeism/prevent daily activities/seek health care

24 Online survey acceptable to majority of participants (91%) I think that it's good that you are making an effort to gather information in a formalized manner. With the introduction of Flumist to the younger target group, it's good to get feedback on what happens after the kids/youth left the clinic. Thank you.

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26 CANVAS: Next Steps Developed AEFI app for apple and android phones Ability for notifications/reminders Ability to collect data at multiple time points (eg 48, 72 hours and 29 days after immunization)

27 CANVAS: Next Steps Developed AEFI app for apple and android phones Ability for spontaneous reporting

28 CANVAS: App Beta Test Beta testing app this fall: live and simulated stream Live Stream: 71 enrolled in live stream; 36 downloaded app 16 completed 8 day survey Simulated Stream: Test AEFI reporting mechanism for severe event

29 CANVAS: Next Steps Starting in 2015 European regulatory authorities will drop requirement for pre-licensure clinical trials for seasonal influenza vaccines Recommend enhanced surveillance Ability to rapidly detect clinically significant change Need for control group for background rates Not expected to identify rare event Recommendations very similar to CANVAS CANVAS produced a report for EMA on 2014 seasonal vaccines

30 CANVAS: Next Steps Enhanced surveillance for mass immunization programs of new vaccines CANVAS site in Quebec currently monitoring safety of MenB vaccine Potential to augment CANVAS app with bar code scanning Identify based on vaccine lot Canada will be first country licensed to use Fluad in children in 2015 Ability to provide rapid safety data on this product

31 CANVAS Investigators Influenza Surveillance Mobile Safety App Louis Valiquette Centre Hospitalier Uni. de Sherbrooke Gaston De Serres Centre Hospitalier Uni. de Québec Ann McCarthy Ottawa Hospital Brenda Coleman Mount Sinai Hospital Shelly McNeil Queen Elizabeth II Health Sciences Centre Otto Vanderkooi Alberta Children s Hospital Karina Top and Jennifer Isnor Canadian Center for Vaccinology Kumanan Wilson and Dean Fergusson, Ottawa Hospital Research Institute Shelley Deeks and Natasha Crowcroft, Public Health Ontario CANVAS app developed by Sigvaria Mobile Technologies, Inc.

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