www.ncirs.usyd.edu.au www.ncirs.usyd.edu.au Alexis Pillsbury On 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
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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
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