Friday Alexis Pillsbury 1.30pm.ppt
Transcript of Friday Alexis Pillsbury 1.30pm.ppt
www.ncirs.usyd.edu.auwww.ncirs.usyd.edu.au
Alexis PillsburyOn behalf of the AusVaxSafety National Project Group
AusVaxSafety: Engaging parents in vaccine safety surveillance using new technologies provides timely data on annual influenza vaccine safety in young children
The AusVaxSafety National Project GroupNSW: Kristine Macartney, Nicholas Wood, Karen Orr, Gulam Khandaker, David Durrheim, Patrick Cashman, Craig Dalton, Sally Munnoch, Michelle Butler, Stephen Clarke, Mark Ferson, Deborah Thomson, Keira Glasgow, Lauren Dalton, Stephen Corbett , Salwa Gabriel, Michael Crampton, Maria Pipicella, Brendan McMullan, Geraldine Dunne;
Vic: Jim Buttery, Nigel Crawford, Gowri Selvaraj, Annette Alafaci, Peter Eizenberg;
WA: Christopher Blyth, Paul Effler, Peter Richmond, Tom Snelling, Annette Regan, Lauren Tracey, Gabriela Willis, Jennifer Kent, Alan Leeb, Ian Peters, Rachel West;
QLD: Kari Jarvinen, Susan Vlack, Melinda Hassall, Julia Clark, Stephen Lambert;
SA: Michael Gold, Gabriella Lincoln;
NT: Rosalind Webby, Kaylene Prince.
Prologue: 2010-2012
Chapter One: Pilot, 2013
Chapter Two: AusVaxSafety, 2014
Chapter Three: AusVaxSafety, 2015
Challenges ahead
The bigger picture
Prologue:2010-2012
Federation of states & territories
Vaccines administered vary by state/territory
Differences in recommendations & immunisation programs
Different state/territory vaccine safety surveillance mechanisms
2010-2012 active influenza vaccine safety surveillance grows organically, primarily in 2 states…
2010: WA influenza vaccine safety scare in children <5 yrs
Increased fever/febrile seizures associated with Fluvax & Fluvax Junior (CSL Biotherapies)
2010: NSW 6 month, hospital-based influenza immunisation program
2011: Prospective safety study of 144 children in Perth hospital & clinic
Results showed 2011 influenza vaccines safe
Incorporated telephone interviews to parents of children 6mo-<5yr re: reactions
Demonstrated significant higher rate of fever reported with Fluvax compared to Influvac or Panvax; no febrile convulsions2011: Australian Government Department of Health & Ageing review
Recommendation 7: The collection of vaccine usage & safety monitoring data should be a key priority for future e-health planning & development.
2011: Vaxtracker developed in Hunter New England; piloted 2012 NSW
Nov 2011-June 2013: SmartVax piloted in WA
Lasting impact from 2010 vaccine safety scare
Influenza vaccine uptake among children in Western Australia
Chapter One:
The Pilot, 2013
The Pilot, 2013Australian Government Department of Health funded national pilot of active post-marketing surveillance of
influenza vaccines registered for use in children.
Demonstrating consistently low rate of side effects for each annual vaccine important for vaccine confidence and uptake
Particularly important for influenza vaccineswhich can vary year to year
The Pilot, 2013 Active surveillance Parental reporting of reactions & medical advice sought Influenza vaccinations administered in outpatient clinics/primary health care providers Follow-up 3-5 days post-vaccination with nurse telephone call to parents
• Results consistent with clinical trials/observational studies• 2013 influenza vaccines registered for use in young
Australian children safe & well-tolerated
Wood et al, MJA. 2014.
• 893 children (6 months - <10 years); NSW, WA, Vic• 5.5% fever; 2.6% sought medical follow-up
Chapter Two:
AusVaxSafety, 2014
AusVaxSafety, 2014
WANSWVIC
Department of Health competitive tender enhanced adverse reaction surveillance in children <5 years receiving influenza vaccine
Multijurisdictional collaboration using computer-based platforms to actively obtain parental reports of reactions
NSW/VIC: Parents SMS or emailed link to web-based survey (‘Vaxtracker’)
WA: Parents SMSed asking about reactions; called if they reply ‘yes’ or no response (‘FAST’ study)
Real-time safety signal detection 782 survey responses
• 6.8% fever; 1.5% medical follow-up • Rates of reactions within expected range• 2014 influenza vaccines registered for use in
young Australian children safe & well-tolerated
AusVaxSafety, 2014
Chapter Three:
AusVaxSafety, 2015
AusVaxSafety, 2015 Expanded surveillance capacity
• Two computer-based surveillance systems
Expanded participant numbers
Data entry Parents contacted
Parents reply Primary setting Active/ passive parental involvement
VaxtrackerNSW, Vic
Manual entry SMS Web-based reply GPsHospitalsAboriginal Medical Services
Parents actively recruited AusVaxSafety
SmartvaxWA
Automatedentry
SMS SMS reply GPs Parents receive SMS as routine duty of care
2014 2015
Invited 948 3746
Enrolled 879 3709
Surveys completed
782 3264
AusVaxSafety, 2015Participant details (based on number of surveys completed)
Age (median months; range)24.0 months (6.0–59.9 months)
Gender* (N; %)Male 1770 (54.7%)Female 1468 (45.3%)
Ethnicity** (N;%)Indigenous 129 (4.6%)Non-indigenous
2653 (95.4%)
Underlying medical condition*** (N;%)393 (33.4%)
*26 participants with unknown gender**482 participants with unknown ethnicity***2,167 participants with unknown underlying medical condition status
Male 51.4%Female 48.6%
Indigenous 4.1%Non-indigenous 95.9%
General populationᵻᵻ
ᵻᵻBased on 0-4 yr age group population estimates for NSW, WA, and NT (Australian Bureau of Statistics)
AusVaxSafety, 2015Vaccine brand received(based on number of surveys completed)
N(%)*
Vaxigrip(Sanofi-Pasteur)
3,025 (92.7%)
Fluarix(GlaxoSmithKline)
173 (5.3%)
Influvac(BGP Products)
45 (1.4%)
Agrippal(Novartis Vaccines & Diagnostics)
7 (0.2%)
FluQuadri(Sanofi-Pasteur)
12 (0.4%)
*Brand unknown for 1 participant; 1 reported as receiving generic vaccine
2014Vaxigrip: 674 (86.2%)Fluarix: 84 (10.7%)
AusVaxSafety, 2015
Participant reactions reported N (%)Fever 125 (3.8%)Injection site reaction 55 (1.7%)Vomiting/abdominal pain 36 (1.1%)Rash 31 (1.0%)Seizure 4 (0.1%)
Of the 33 seeking medical assistance/advice, 20 had fevers
Medical advice/assistance sought for reaction: 33 (1.0%)
AusVaxSafety, 2015
33 participants sought medical assistance/advice: NGeneral Practitioner/medical practitioner/telephone advice 26Emergency Department/hospital 7
Of the 7 presenting to the ED and/or hospitalised, 3 ended up being classified by AusVaxSafety as serious adverse events.
1. Fluarix received; febrile seizure; history of febrile seizures; fever 38.8°C; concomitant vaccines (MMR 2nd dose; IPV); ED
2. Influvac received; flu-like illness; fever 39°C; ED; hospitalised
3. Vaxigrip received; seizure; history of epilepsy; no fever; concomitant vaccine (MMR 2nd dose); ED
AusVaxSafety, 2015
Adverse reactions (fever/medical assistance/advice sought) associated with concomitant vaccine receipt
Concomitant vaccine
received*
Fever (N; %) P value Medical assistance/advice sought (N; %)
P value
Yes No
0.004
Yes No
0.054YesN=609
34 (5.6) 575 (94.4) 9 (1.5) 600 (98.5)
NoN=2491
78 (3.1) 2413 (96.9) 17 (0.7) 2474 (99.3)
*Details on concomitant vaccine receipt missing for 164 participants
AusVaxSafety, 2015Adverse reactions (fever/medical assistance/advice sought) associated with
vaccine brand (Vaxigrip or Fluarix) receiptVaccine brand
received*
Fever (N; %) P value Medical assistance/advice sought (N; %)
P value
Yes No
0.519
Yes No
0.264VaxigripN=3025
111 (3.7) 2914 (96.3) 27 (0.9) 2998 (99.1)
FluarixN=173
8 (4.6) 165 (95.4) 3 (1.7) 170 (98.3)
*N=3,198
AusVaxSafety, 2015• Rates of reactions within
expected ranges
• 2015 influenza vaccines registered for use in young Australian children safe & well-tolerated
• Association between concomitant vaccine receipt & fever necessitates further analysis
AusVaxSafety: challenges ahead
Challenges of integrating data from 2 different technological platforms into 1 surveillance system
Governance & ethics streamlining across states/territories as AusVaxSafety expands
Potential for AusVaxSafety to include other vaccines & challenges of adapting system to do so
AusVaxSafety: the bigger picture
Active sentinel surveillance provides real-time data
Parental acceptance high – increasing enrolment & participant numbers
Important for maintaining public/provider confidence in influenza vaccines registered for young children
AusVaxSafety surveillance data can inform Northern Hemisphere counterparts of safety profiles of vaccines used in Southern Hemisphere flu season