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3 Highlights from the 2017 Ontario Vaccine Safety Report Michelle Murti, Gillian Lim Immunization and Vaccine Preventable Diseases Communicable Diseases, Emergency Preparedness and Response November 27, 2018 PHO Rounds

4 Learning objectives Describe the process and importance of vaccine safety surveillance in Ontario Summarize adverse events reported in Ontario following vaccines administered in 2017 Understand the value of the vaccine safety surveillance tool in being able to readily access local and provincial vaccine safety data 4

5 Why is vaccine safety important? Public confidence in vaccine safety is critical to immunization program success Higher standard of safety is expected of vaccines Administered to large numbers of healthy people Low risk tolerance Vaccines are universally recommended, subject to mandatory choice Increased attention on safety with decreasing disease risk Misperception persists 5

6 Vaccine safety in the news Source: Burns A. Toronto Sun newspaper pulls column skeptical of vaccines after backlash. CTV News [Internet], 2018 Oct 29 [cited 2018 Nov 2]; Health. Available from: Source: HealthDay News. Safety concerns are main reason parents hesitate on HPV vaccine. UPI [Internet], 2018 Oct 30 [cited 2018 Nov 2]; Health News. Available from: Source: Roberts K. When it comes to vaccines, celebrities often call the shots. NBC News [Internet], 2018 Oct 28 [cited 2018 Nov 2]; Health Care. Available from: 6

7 The vaccine safety system in Canada A shared responsibility Highly regulated and inspected process Safety monitored continuously throughout product lifecycle Success depends on communication and coordination across multiple stakeholders Source: Health Canada. Life-cycle management [Internet]. Ottawa, ON: Government of Canada; [modified 2007 Apr 11; cited 2017 Nov 2]. Available from: 7

8 AEFI = Adverse event following immunization An AEFI is any untoward medical occurrence that follows immunization It does not necessarily have a causal relationship with the vaccine The adverse event may be any unfavourable or unintended sign, laboratory finding, symptom, or disease. AEFIs can be caused by the vaccine or may occur by chance Includes both expected (i.e. listed in product monograph) and unexpected events An AEFI is not the same as side effects which are linked to a vaccine by scientific studies 8

9 Public health surveillance of vaccine safety Core component of the vaccine safety system Collaborative system led by Public Health Agency of Canada; all 13 P/T public health authorities participate Passive reporting of individual case reports (AEFIs) Identifies rare events not detected during clinical trials Generates safety signals that warrant further investigation Informs regulatory actions, public health decision making and communication Active reporting of paediatric cases through IMPACT Other post-marketing surveillance activities support ongoing monitoring of safety 9

10 Detection and reporting Investigation Dissemination and communication Vaccine safety surveillance cycle Analysis Interpretation 10

11 Vaccine safety surveillance in Ontario AEFIs are identified and reported by health care providers, vaccine recipients or their caregivers Health care provider reporting is mandated (Health Protection and Promotion Act, R.S.O. 1990, c. H.7) Public health units play a central role Receive, assess and investigate AEFI reports Documentation according to provincial surveillance criteria Provide information, support and advice to vaccine recipients and health care providers in their community 11

12 Roles of public health vaccine safety partners Adverse event case reports Vaccine recipients Caregivers/parents Health care providers (physicians, nurses, pharmacists) Health Canada Regulator Public Health units Receive, assess and investigate case reports Document using provincial surveillance guidelines Provide information, support and advice Public Health Ontario Provincial surveillance Routine monitoring, annual reports, ad hoc analyses Support and advice for PHUs Ministry of Health and Long-Term Care Immunization legislation, policy and procurement Vaccine supply Public Health Agency of Canada National surveillance and standards

13 Vaccine PHO Provincial AEFI surveillance Routine monitoring, annual reports, ad hoc analyses Surveillance system documentation (i.e. case definitions, user guides, etc.) Participation in national surveillance system Public health unit support AEFI reporting process issues IPHIS training and support Advice on complex AEFIs Tools and resources for immunizers and health care providers who report AEFIs Member of WHO s Vaccine Safety Net 13

14 Annual Report on Vaccine Safety in Ontario, 2017 Released Thursday November 15 Annual report (PDF) Technical annex Immunizer overview Online, interactive data tool Ontario Agency for Health Protection and Promotion (Public Health Ontario). Annual report on vaccine safety in Ontario, Toronto, ON: Queen s Printer for Ontario;

15 Annual Report on Vaccine Safety in Ontario, 2017 Objectives To summarize AEFIs reported in Ontario following vaccines administered in 2017 To assess AEFI reporting trends over six years ( ) 15

16 Methods Data extracted from the integrated Public Health Information System (iphis) on May 11, 2018 Active immunizing agents only; publicly funded and non-publicly funded vaccines Descriptive analysis limited to confirmed AEFIs Reporting rates calculated based on population estimates/projections for overall rates and doses distributed for vaccine-specific rates Serious AEFIs defined using standard WHO definition adapted for use in Ontario 16

17 Demonstration of the Online Vaccine Safety Tool: 17

18 Demonstration of the Online Vaccine Safety Tool: 18

19 Demonstration of the Online Vaccine Safety Tool: 19

20 Geographic distribution: School-based vaccines, 2017 Reporting rate per 100,000 population for AEFIs among year olds following Men-C- ACWY, HB, HPV4 or HPV9 vaccine by public health unit: Ontario, 2017 Notes: HPV9 replaced HPV4 in September 2017 Expansion of HPV program to males in September

21 Geographic distribution: Influenza vaccine, 2017 Reporting rate per 100,000 doses distributed for AEFIs following influenza vaccine by public health unit: Ontario,

22 Reporting rates and number of AEFIs by infant and childhood vaccines,

23 Reporting rates and number of AEFIs by adolescent vaccines*, 2017 * HPV9 replaced HPV4 in September 2017; expansion of HPV program to males in September

24 Reporting rates and number of AEFIs by routine adult* and influenza vaccines, 2017 * Zos became a publicly-funded vaccine program for persons between 65 and 70 years old in September

25 Number of serious and non-serious AEFI reports by adverse event category: Ontario, 2017 Injection site reactions Systemic events Allergic events Neurological events Other severe/unusual events Serious AEFIs 25

26 Serious AEFIs 26 serious AEFIs (3.7% of reports) Reporting rate of 1.8 per million population 25 following publicly funded vaccine, or 2.9 per million doses distributed 73.1% (n=19) < 18 years, with most < 4 years (n=16) 25 hospitalized, mean length of stay of 10 days Febrile illness (n=8) was most frequently reported 7 in children <4 years One reported death: one year-old occurring within 24 hours of receipt of DTaP-IPV-Hib. 26

27 Specific adverse events Injection site reactions The most frequently reported event (48.9% of all reports) Rash Most frequently associated vaccines: Zos and Pneu-P-23 Second most frequent reported event (22.8% of reports) 45.3% associated with live virus vaccines 4 confirmed vaccine-strain virus by genotyping Anaphylaxis 28 reports of anaphylaxis (3.3 per million doses distributed) 27

28 Anaphylaxis review of 28 reported events Most frequently reported vaccines were: Inf (n=13) Men-C-ACYW (n=4) DTaP-IPV-Hib (n=3) HPV-9 (n=3) No reports were classified as serious 15 (53.6%) met Brighton definition (1.8 per million doses), lower than in 2016 (80%, 8/10) 7 Level 1; 7 Level 2; 1 Level 3; 13 Level 4 Within expected range 1-10 episodes per million doses Importance of applying case definition assessment 28

29 Anaphylaxis management and reporting Early recognition of anaphylaxis (life-threatening) vs: Fainting, anxiety or breath-holding Swelling and urticarial rash at the injection site Prompt administration of epinephrine is the priority Treatment will stop symptom progression and individuals may display fewer symptoms Impact of treatment on symptoms for Brighton case definition Referral and recommendations for future vaccination PHO s Anaphylaxis Reporting Form Public Health Agency of Canada. Canadian immunization guide: part 2 vaccine safety. Early vaccine reactions including anaphylaxis [Internet]. Ottawa, ON: Government of Canada; 2013 [modified 2016 Sep 1; cited 2018 Nov 4]. Available from: 29

30 AEFI REPORTING IN 3 STEPS 30

31 Summary Overall, low rate of AEFI reporting in Ontario with no unexpected vaccine safety issues Most commonly reported events were mild; serious events were very rare Ongoing surveillance of AEFIs in Ontario is needed to monitor vaccine safety and to develop strategies to address under-reporting within the surveillance system 31

32 Next steps Continue to develop online resources including the interactive data tool Further collaboration with PHUs and MOHLTC to develop strategies to address underreporting of AEFIs Engage system stakeholders and encourage continued AEFI reporting Participate in upcoming survey to evaluate how well PHOs vaccine safety resources are meeting PHU needs Contact us: 32

33 Acknowledgements Tara Harris Shelley Deeks Whitley Meyer Harjot Dhaliwal Kelty Hillier Shinthuja Wijayasri Bryna Warshawsky Brenda Lee Alex Dunaevsky Rachelle Cuevas Steven Johnson All the PHU and MOHLTC staff involved in Vaccine Safety Surveillance in Ontario 33

34 Questions 34

35 For More Information About This Presentation, Contact: Public Health Ontario keeps Ontarians safe and healthy. Find out more at