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