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Let’s get visual with vaccine safety in Ontario!
Chi Yon Seo, Tara Harris
November 14, 2017
PHO Rounds
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Learning objectives
2
• 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
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Why is vaccine safety important?
3
• 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
© Chris Madden, 2015. Reproduced with permission.
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Vaccine safety in the news
4
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: https://www.statnews.com/2016/11/30/donald-trump-vaccines-policy/ Associated Press. Zuckerberg wades into vaccine debate with baby shots photo. CNBC [Internet], 2016 Jan 12 [cited 2017 Nov 7]; Health Care. Available from: https://www.cnbc.com/2016/01/12/zuckerberg-wades-into-vaccine-debate-with-baby-shots-photo.html Cohen J. France most skeptical country about vaccine safety. Science [Internet], 2016 Sep 8 [cited 2017 Nov 7]; Health. Available from: http://www.sciencemag.org/news/2016/09/france-most-skeptical-country-about-vaccine-safety 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: https://jezebel.com/robert-de-niro-promotes-all-kinds-of-anti-vaccination-n-1770709195
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The vaccine safety system in Canada A shared responsibility
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• 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: https://www.canada.ca/en/health-canada/services/drugs-health-products/progressive-licensing/progressive-licensing-model/life-cycle-management-progressive-licensing-model-drugs-health-products.html
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AEFI = Adverse event following immunization
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• 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
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.
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Public health surveillance of vaccine safety
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• 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)
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Investigation
Analysis
Interpretation
Dissemination and
communication
Detection and
reporting
8
AEFI surveillance
cycle
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Vaccine safety surveillance in Ontario
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• 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
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Vaccine safety @ PHO
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• 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
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Annual Report on Vaccine Safety in Ontario, 2016
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• Released Thursday November 9 • Annual report (PDF)
• Technical annex
• Immunizer overview
• Online, interactive data tool
www.publichealthontario.ca/vaccinesafety
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Annual Report on Vaccine Safety in Ontario, 2016
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Objectives
• To summarize AEFIs reported in Ontario following vaccines administered in 2016
• To assess AEFI reporting trends over five years (2012-2016)
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Methods
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• 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
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Reporting trends, 2012-16
Number of AEFI reports and reporting rate per 100,000 population by year: Ontario, 2012-16
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Age distribution, 2012-16 Annual AEFI reporting rate per 100,000 population by age group: Ontario, 2012-16
• 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%)
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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 Ontario1
1. Harris T, Nair J, Fediurek J, Deeks SL. Assessment of sex-specific differences in adverse events following immunization reporting in Ontario, 2012-15. Vaccine. 2017;35(19):2600-4. Available from: http://www.sciencedirect.com/science/article/pii/S0264410X17303419
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Geographic distribution: All vaccines, 2016 Overall AEFI reporting rate per 100,000 population by public health unit: Ontario, 2016
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Geographic distribution: School-based vaccines, 2016
Reporting rate per 100,000 population for AEFIs among 11-17 year olds following Men-C-ACWY, HB or HPV4 vaccine by public health unit: Ontario, 2016
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Geographic distribution: Influenza vaccine, 2016
Reporting rate per 100,000 doses distributed for AEFIs following influenza vaccine by public health unit: Ontario, 2016
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Reporting rates and number of AEFIs by vaccine, 2016
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Vaccine Number of
AEFI reports
Vaccine-
specific
reporting rate
Number
of serious
reports
Vaccine-specific
serious
reporting rate
Doses
distributed
Infant and childhood vaccines
DTaP-IPV-Hib 67 11.7 10 1.7 574,321
Pneu-C-13 49 10.3 8 1.7 476,535
Rot-1 24 9.1 4 1.5 264,617
Men-C-C 21 10.1 2 1.0 207,992
MMR 37 13.5 2 0.7 274,688
Var 56 25.3 2 0.9 221,113
MMRV 18 10.4 0 0.0 173,828
Tdap-IPV 26 10.8 1 0.4 240,867
Adolescent vaccines
Men-C-ACWY 38 20.8 2 1.1 182,604
HB 69 26.9 2 0.8 256,264
HPV4 69 32.9 1 0.5 209,474
Tdap 65 8.1 0 0.0 804,844
Routine adult vaccines
Pneu-P-23 66 27.8 0 0.0 237,535
Td 7 3.4 0 0.0 203,574
Universal Influenza Immunization Program (UIIP)
Inf 120 3.3 4 0.1 3,603,830
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Number of serious and non-serious AEFI reports by adverse event category: Ontario, 2016
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Serious AEFIs
Systemic events
Injection site
reactions
Allergic events
Other
severe/unusual
events
Neurological
events
0 50 100 150 200 250
Other severe/unusual events
Myelitis
Guillian-Barré Syndrome
Bell's palsy
Convulsions/seizure
Anaesthesia/paraesthesia
Oculorespiratory syndrome
Event managed as anaphylaxis
Allergic reaction - skin
Parotitis
Intussusception
Thrombocytopenia
Hypotonic-hyporesponsive episode
Persistent crying/screaming
Arthritis/arthralgia
Adenopathy/lymphadenopathy
Syncope with injury
Severe vomiting/diarrhea
Fever
Rash
Sterile abscess
Infected abscess
Nodule
Cellulitis
Pain/redness/swelling
Number of reports
Ad
vers
e e
ven
t
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Specific adverse events
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• 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)
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Serious AEFIs
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• 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
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Serious AEFIs
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• 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
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Summary
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• 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
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Online vaccine safety surveillance tool
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• 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
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Vaccine safety surveillance tool
www.publichealthontario.ca/vaccinesafety
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Next steps
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• 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: [email protected]
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Acknowledgements
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• 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
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Date: Wednesday, November 15, 2017 Location: DoubleTree by Hilton, Downtown Toronto Webinar option available Visit ‘Upcoming Events’ Page : www.publichealthontario.ca
Vaccine Sciences Symposium 2017