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3 Let s get visual with vaccine safety in Ontario! Chi Yon Seo, Tara Harris November 14, 2017 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 2016 Understand the value of the vaccine safety surveillance tool in being able to readily access local and provincial vaccine safety data 2

5 Chris Madden, Reproduced with permission. 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 3

6 Vaccine safety in the news Robbins R. Meeting with Trump emboldens anti-vaccine activists, who see an ally in the Oval Office. Stat [Internet], 2016 Nov 30 [cited 2017 Nov 7]; Politics. Available from: Associated Press. Zuckerberg wades into vaccine debate with baby shots photo. CNBC [Internet], 2016 Jan 12 [cited 2017 Nov 7]; Health Care. Available from: Cohen J. France most skeptical country about vaccine safety. Science [Internet], 2016 Sep 8 [cited 2017 Nov 7]; Health. Available from: Merlan A. Robert De Niro Promotes All Kinds of Anti-Vaccination Nonsense in Wild Today Interview. Jezebel [Internet], 2016 Apr 13 [cited 2017 Nov 7]. Available from: 4

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 Government of Canada. Life-cycle management [Internet]. Ottawa, ON: Government of Canada; 2007 [cited 2017 Nov 2]. Available from: 5

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 6

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 (adverse events following immunization/aefi) Identifies rare events not detected during clinical trials Generates safety signals that warrant further investigation Informs regulatory actions, public health decision making and communication Other post-marketing surveillance activities support ongoing monitoring of safety (e.g., IMPACT) 7

10 Detection and reporting Investigation Dissemination and communication AEFI surveillance cycle Analysis Interpretation 8

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) 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 9

12 Vaccine PHO PHO conducts 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 10

13 Annual Report on Vaccine Safety in Ontario, 2016 Released Thursday November 9 Annual report (PDF) Technical annex Immunizer overview Online, interactive data tool 11

14 Annual Report on Vaccine Safety in Ontario, 2016 Objectives To summarize AEFIs reported in Ontario following vaccines administered in 2016 To assess AEFI reporting trends over five years ( ) 12

15 Methods Data extracted from the integrated Public Health Information System (iphis) on May 9, 2017 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 13

16 Reporting trends, Number of AEFI reports and reporting rate per 100,000 population by year: Ontario,

17 Age distribution, Annual AEFI reporting rate per 100,000 population by age group: Ontario, Age range in 2016: one month to 91 years of age Slight majority of AEFI reports in those < 18 years compared to adults 18 years (52.4% vs. 47.6%) 15

18 Age and sex distribution, 2016 Number of AEFI reports and reporting rates per 100,000 population by age group and sex: Ontario, 2016 In 2016, 65.6% of AEFI reports were female; a female predominance consistently observed in Ontario 1 1. Harris T, Nair J, Fediurek J, Deeks SL. Assessment of sex-specific differences in adverse events following immunization reporting in Ontario, Vaccine. 2017;35(19): Available from: 16

19 Geographic distribution: All vaccines, 2016 Overall AEFI reporting rate per 100,000 population by public health unit: Ontario,

20 Geographic distribution: School-based vaccines, 2016 Reporting rate per 100,000 population for AEFIs among year olds following Men-C- ACWY, HB or HPV4 vaccine by public health unit: Ontario,

21 Geographic distribution: Influenza vaccine, 2016 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 vaccine, 2016 Vaccine Number of AEFI reports Vaccinespecific reporting rate Number of serious reports Vaccine-specific serious reporting rate Doses distributed Infant and childhood vaccines DTaP-IPV-Hib ,321 Pneu-C ,535 Rot ,617 Men-C-C ,992 MMR ,688 Var ,113 MMRV ,828 Tdap-IPV ,867 Adolescent vaccines Men-C-ACWY ,604 HB ,264 HPV ,474 Tdap ,844 Routine adult vaccines Pneu-P ,535 Td ,574 Universal Influenza Immunization Program (UIIP) Inf ,603,830 20

23 Adverse event Number of serious and non-serious AEFI reports by adverse event category: Ontario, 2016 Pain/redness/swelling Cellulitis Nodule Infected abscess Sterile abscess Rash Fever Severe vomiting/diarrhea Syncope with injury Adenopathy/lymphadenopathy Arthritis/arthralgia Persistent crying/screaming Hypotonic-hyporesponsive episode Thrombocytopenia Intussusception Parotitis Allergic reaction - skin Event managed as anaphylaxis Oculorespiratory syndrome Anaesthesia/paraesthesia Convulsions/seizure Bell's palsy Guillian-Barré Syndrome Myelitis Other severe/unusual events Injection site reactions Systemic events Allergic events Neurological events Other severe/unusual events Serious AEFIs Number of reports 21

24 Specific adverse events Injection site reactions Most frequently reported (48.7% of all reports) Most frequently associated vaccines: Pneu-P-23 and Var Rash Second most frequent reported event (22.1% of reports) 41.0% associated with live virus vaccines 3 confirmed vaccine-strain virus by genotyping (2 measles, 1 varicella-zoster) Anaphylaxis 8 reports; 1.0 per million doses distributed 6 met Brighton definition (four level I, two level II diagnostic certainty) 22

25 Serious AEFIs 19 serious AEFIs (3.0% of reports) Reporting rate of 1.4 per million population or 2.3 per million doses distributed 89.5% (n=17) < 18 years, with most < 4 years (n=15) 42.1% (n=8) documented as reported by IMPACT 21.1% (n=4) documented to have been referred to the Special Immunization Clinic (SIC) network 23

26 Serious AEFIs All hospitalized, mean length of stay of 4.0 days Febrile illness (n=12) was the most frequently reported event 11 in children <10 years Includes 3 reports of Kawasaki disease One report of death in 2016 in an elderly adult Immune compromising medications, received zoster vaccine Live vaccines, including zoster vaccine are contraindicated in immunocompromised persons and persons on immune compromising medications 24

27 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 25

28 Online vaccine safety surveillance tool Online, interactive tool allows users to explore, manipulate and download vaccine safety data Inform decision-making by public health practitioners Support health professional communication about vaccine safety Initial design and usability testing conducted in consultation with public health stakeholders Updated annually for enhanced functionality and usability 26

29 Vaccine safety surveillance tool 27

30 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 Suggestions and feedback on our products and resources? Contact us: 28

31 AEFI REPORTING IN 3 STEPS 29

32 Acknowledgements Shelley Deeks Kelty Hillier Jody Stapleton Jyotsna Nair Bryna Warshawsky Jodi Gatley LeeAnn Desa Brenda Lee Alex Dunaevsky Kate Curzon Stacie Carey Lucia Zdeb Steven Johnson Vaccine safety surveillance tool usability testers All the PHU and MOHLTC staff involved in Vaccine Safety Surveillance in Ontario 30

33 Vaccine Sciences Symposium 2017 Date: Wednesday, November 15, 2017 Location: DoubleTree by Hilton, Downtown Toronto Webinar option available Visit Upcoming Events Page : 31

34 Questions 32

35 Extra slides 33

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