vaccine safety in australia and internationally ncirs 20th ... · intussusception (is) following...
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www.ncirs.usyd.edu.au
Vaccine Safety – In Australia and Internationally
NCIRS 20th Anniversary celebrations
November 2017
Associate Professor Kristine Macartney
Deputy Director, NCIRS
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Vaccines held to highest possible safety standards
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Why are so well placed to understand vaccine safety?
Clinical trials › Policy advisory › Evaluation › Clinical services
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What we see determines our view
Case study
Population = 200,000
Vaccination coverage = 80%
Background event rate = 1 case per 10,000 (eg MS, GBS)
We need the whole picture !!!
Adverse Event
Total Rate = same (0.0001%)
Yes No
Vaccinated 16 159,984 160000
Not vaccinated 4 39,996 40000
Slide adapted from Alex Vorsters, Belgium with thanks
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http://www.euro.who.int/__data/assets/pdf_file/0010/339625/Vaccine-safety-messages.pdf
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Expected coincidental deaths following DTP vaccination in selected
countries
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1999 USA
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NCIRS analysis: Adverse events following immunisation, TGA ADRS database, 2000 to 2016, by
quarter of vaccination, by date of vaccination
2001: NCIRS commences analysis of national AEFI reports
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NCIRS analysis: Adverse events following immunisation for children aged <1 year, ADRS
database, 2000 to 2016, by quarter of vaccination, by date of vaccination
Numbers of reports increase:
• New vaccines added
• Population growth
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2005 NCIRS National vaccine safety workshop
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Recruit patients that meet criteria
•Waiver of consent •Patient data collection •Collection of specimens
Analyses
Before – after incidence (RI)
VE using TND (controls)
Severity, risk factors
2007: 3 conditions
↓
2017: 9 conditions
Active Surveillance by NURSE
Emergency department
Inpatients
Intensive care
Laboratory results
Clinician notification
Sentinel real-time hospital-based
surveillance www.paeds.edu.au
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Australia’s landmark contribution to definining
Intussusception (IS) following new rotavirus vaccines
2007 rotavirus vaccination on NIP
2011 PAEDS Sentinel surveillance – clinically
confirmed cases: comparison with historical ICD-coded
data
2013 Case ascertainment (PAEDS and S/T) 2 sources
Self controlled case series – IRR in risk v. non risk
periods (0-7;0-21 days post vaccination compared with
non risk periods)
2014 No difference in clinical outcomes (vaccine
associated/non vaccine associated)
2016 Trends in hospital-coded IS – temporary increase
in dose 1 age group (1-3 months only)
Buttery, J, Danchin M et al, Vaccine 2011; Quinn, et al, PIDJ 2012; Carlin JB, Macartney K, Lee KJ, et al. Clinical Infectious
Diseases 2013;57:1427-1434; Buttery et al PHAA NIC 2014; Dey, A International Rotavirus meeting 2016, Melbourne.
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Methods: Estimates based on method of Patel, et al, NEJM 2011
#: annual number of ICD-coded hospitalisations (data from the Australian Institute of Health and Welfare) for rotavirus AGE and estimated for rotavirus-attributable
AGE (derived from Dey et al, MJA 2012 and Jayasinghe et al, Vaccine 2013). Vaccine effectiveness estimates applied by dose (see appendix).
•derived from using ICD-coded hospitalisations (data from the Australian Institute of Health and Welfare) for IS with adjustment for cases confirmed as IS, vaccine
coverage, age
Annual Hospitalisations
in children < 5 years of
age
Without
vaccination
program
With
vaccination
program
Number of events
averted or caused
Rotavirus attributable
gastroenteritis#
11073 4545 - 6528
Intussusception using
RotaTeq and/or Rotarix* 144 158 14
Effect of a rotavirus vaccination program, as compared with
no rotavirus vaccination program in Australia
Carlin JB, Macartney K, Lee KJ, et al. Clinical Infectious 2013;57:1427-1434.
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Conclusions
• Additional 2 cases of IS per 100,000 infants vaccinated
• 14 extra cases above ~ 200 seen annually
• Benefits of vaccination outweigh risks – Australia and internationally
• www.immunise.health.gov.au
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2007
• 1 month into program commencement
• 1 school: 26 girls in sick bay post vaccination, 4 to ED
• no organic cause
• prompt thorough response, follow-up, communication
Buttery J et al, MJA 2008; Clements ANZJPH 2007
Key HPV vaccine safety events
Australia
2007 Mass psychogenic illness
Anaphylaxis signal - NSW
2009 Mulitple sclerosis
Injection site adverse events
2013 New vaccine safety plan for
adding males to NIP
2013 Key NCIRS systematic review
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Alarming recent declines in
HPV vaccine uptake
overseas
http://globalcancerinstitute.org/health-trends/hpv-vaccine-uptake-latin-america/
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Australia:
Vaccine coverage is rising over time National human papillomavirus (HPV) vaccination coverage for girls at age
15, by dose number and year, Australia, 2007–2015
Source: Brotherton et al, Med J Aust 2017 www.hpvregister.org.au/research/coverage-data
Dose 1/2/3 coverage 15 yrs
86/83/78% females
78/75/67% males
14 years in 2015 = higher
87/85/79% females
82/79/74% males
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An adult flu shot did this to my boy The Telegraph Sunday November 10, 2013
2010 – Influenza vaccine (Fluvax/CSL) and febrile seizures
0%
10%
20%
30%
40%
50%
60%
WA: Fluvax 2010
Febrile convulsions in 0.5-1% of
children receiving influenza vaccine
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National Immunisation Strategy
2013-2018 Horvath review of vaccine adverse
events system 2011
Investigation into influenza vaccine
safety problems
7 Recommendations
including: • Evaluate benefits of additional
surveillance mechanisms to ensure
vaccine safety
• Collection of vaccine usage and safety
monitoring data key priority
www.immunise.health.gov.
au
Strategic Priority 4: Continue to
enhance vaccine safety monitoring
systems • Improve AEFI surveillance
• Vaccine safety plans for NIP
• Raise awareness of safety systems
• Data linkage for vaccine safety
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Vaccine Safety plans
New vaccine introduction
Issues specific to
new vaccine
Pre-emptive safety surveillance plan
HPV vaccine
for
males
MMRV vaccine
Horvath review
Influenza vaccine in children
Pertussis vaccines in
children
Zoster vaccine
AUSVAXSAFETY SURVEILLANCE AEFI-CAN
School-based
TGA/JIC
PHREDDS
Febrile
seizures
(PAEDS)
Inappropriate
administration AEFI-CAN
(ELS)
PAEDS (SNE)
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• Varicella uptake improved at age 2 years by 4% (from 85.9 to 89.9%)
• On time vaccination for measles-containing vaccine dose 2 increased by 13.5%
• No increased risk of febrile seizures post MMRV vaccine
(used as dose 2 at age 18 months)
Aug 2017
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Are alternative vaccines safe? Yes
0%
10%
20%
30%
40%
50%
60%
WA: 2011-2012
0%
10%
20%
30%
40%
50%
60%
WA: Fluvax 2010
0%
10%
20%
30%
40%
50%
60%
WA, NSW, Vic: 2014
0%
10%
20%
30%
40%
50%
60%
WA, NSW, Vic, Qld, SA: 2013
Wood NJ et al MJA 2014; AusVaxSafety report 2014, Blyth et al; Vaccine 2011; Blyth et al, MJA 2011; Markus TY –
unpublished data
AUSVAXSAFETY SURVEILLANCE
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What is AusVaxSafety?
Active and novel
Sentinel, routine vaccination
Automated from data extraction from practice software
SMS prompted survey
Patient reported outcomes
All ages
Vaccines: Influenza → Influenza/Pertussis/Zoster → all vaccines
Rapid analysis → weekly, including bayesian signal detection
Real time data
• Vaccine safety
• Vaccine utilisation
• Brand specific
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AusVaxSafety: sites and key facts
224 national surveillance sites
~70% response rate at ~3 days
Focus vaccines • Influenza all ages
• Pertussis boosters children
• Zoster
Pillsbury et al, Eurosurveillance 2016
GPs (89%)
Community
Clinics (7%)
Hospitals (4%)
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Influenza vaccine safety surveillance 1 April 2017 – 3 September 2017
73,560 participants responded (>100K contacted)
• Median age: 57 years (6 months – 102 years)
• 2% ATSI
• 2.7% pregnant
6.6% event rate
0.4% medical attendance rate
Weekly reporting - No safety signals identified
0123456789
% p
art
icip
an
ts
6 months - 4years5 years - 64years65+ years
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NCIRS analysis: Adverse events following immunisation for children aged <1 year, ADRS
database, 2000 to 2016, by quarter of vaccination, by date of vaccination
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2017 Australia
NCIRS and
Vaccine safety
State/Territory based AEFI
reporting
Vaccine safety initiatives
TGA national AEFI reporting
Signal investigation support
Clinical Assessment
AEFI-CAN and NSWISS (AusVaxSAfety)
AusVaxSafety
Participant-based active real-time surveillance
Large linked databases
(WA-NSW)
Primary care data analysis
•- MBS encounters GPRN
•- NPS-Medicine Insight
•(With AusVaxSafety)
Sentinel hospital based surveillance
for serious AEFI
(PAEDS)
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www.ncirs.usyd.edu.au
THANK YOU to all our leaders, dedicated staff, collaborators and stakeholders and all who prevent disease through immunisation
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#NCIRS20YR
Session 4 – Vaccine Communication and Safety – In Australia and
Internationally
Time Topic Speakers and Chairs
3.20 – 4.50 pm Session 4 – Vaccine Communication and Safety – In Australia and Internationally
Chair: Dr Michael Brydon
Chief Executive, The Sydney Children’s
Hospitals Network
3.20 – 3.40 pm Vaccine Hesitancy – An International Perspective Professor Noni MacDonald
3.40 – 4.00 pm Vaccine Communication – Australian and International Lessons Associate Professor Julie Leask
4.00 – 4.20 pm Vaccination in Pregnancy – Effectiveness and Safety Professor Saad Omer
4.20 – 4.40 pm Vaccine Safety – In Australia and Internationally Associate Professor Kristine Macartney
4.40 – 4.50 pm Closing Remarks
Mr David Templeman
President, Public Health Association of
Australia
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www.ncirs.usyd.edu.au
#NCIRS20YR