Data Driven Health Care Improvement:Detecting unsafe vaccines faster

Jim Buttery

Monash Children’s Hospital

Monash University

0

1

1/03

/10

8/03

/10

15/0

3/10

22/0

3/10

29/0

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5/04

/10

12/0

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Background: 2010 timeline

8th March: Trivalent vaccine

launched

Fluvax Junior and Fluvax: CSL

Influvac: Solvay Pharmaceuticals

Vaxigrip: Sanofi Pasteur

13th April: TGA

notified

22nd April: WA suspends

preschool influenza

vaccination program

Reports of febrile convulsions

presenting to PMH ED follow TIV

Saba vaccinated

23rd April: national

suspension child

influenza program

FASTER DETECTION OF REAL PROBLEMS1. Expected- New Data:

Near real time messaging

AusVaxSafety: the how

Page 7

AEFI: Adverse event following immunisationGP: General practiceED: Emergency department

Survey of details

AEFI

Results shared with the

Australian Government

and on website

SMS asking about AEFI

A few days

after vaccination

Flag to clinic

for follow up &

reporting

Attended

GP or ED

No AEFI

De-identified responses

monitored

>320 sites Vaccination

AusVaxSafety overview

Page 8

SMS AEFI? y/n

Yes

SMS - medically attended ?

Yes

No

SMS – url online survey

Nature, Duration, Severity No

AusVaxSafety: the what

1

Seasonal influenza vaccine

(children)

2014

Pertussis booster vaccine

(children)

2015 2016

Zoster vaccine

(seniors)

Seasonal

influenza

vaccine

(all ages)

2017

Men ACWY

vaccine

(adolescents)

2019

HPV vaccine (adolescents)

2018

Pertussis vaccine

(pregnant women)

NIP = National Immunisation Program

All NIP

vaccines

(in

progress)

AusVaxSafety: the why

Page 10

Ability to respond to post-licensure pharmacovigilance needs

Early detection and response to potential vaccine safety signals

Increase confidence in vaccination

www.AusVaxSafety.org.au

Surveillance results through 2019

0.0%

5.0%

10.0%

HPV* MenACWY Influenza Maternal pertussis

Pe

rce

nt

of

Re

spo

nd

en

ts

Any adverse event

Medical attendance

No safety signals detected

Participants 39,584 6,234 236,557 (2019) 6,828

Group 11-14 years 14-19 years 6 months Pregnant women

Surveillance since 2018 20192014

(annually)2018

* Approximately half of HPV doss given with dTpaPage 12

FASTER DETECTION OF REAL PROBLEMSOld data used better:

Consistency

New Visualisation

Analyses

NRA JURISDICTIONS

Passive surveillance: 2010

JURISDICTIONS NRA/TGA

Data visualisation

Standard reporting tables

Administrative function e.g data cleaning

Multiple graphic options

Line lists

Detailed analysis by category

– Vaccine / AEFI / age cohort / time period

Influenza vaccines AEFI by reaction

Influenza AEFI by brand

Fig 1. PRR cumulative (individual year) for Influenza vaccines and fever AEFI, by reported year and week, 2008–2017.

Clothier HJ, Lawrie J, Russell MA, Kelly H, Buttery JP (2019) Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia. PLOS ONE 14(11): e0224702. https://doi.org/10.1371/journal.pone.0224702https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224702

Fig 5. PRR cumulative and ChiSq for influenza vaccines and fever reactions by reporting week, 2010.

Clothier HJ, Lawrie J, Russell MA, Kelly H, Buttery JP (2019) Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia. PLOS ONE 14(11): e0224702. https://doi.org/10.1371/journal.pone.0224702https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224702

0

1

1/03

/10

8/03

/10

15/0

3/10

22/0

3/10

29/0

3/10

5/04

/10

12/0

4/10

19/0

4/10

26/0

4/10

2010 data- 2019 implementation

8th March: Trivalent vaccine

launched

Fluvax Junior and Fluvax: CSL

Influvac: Solvay Pharmaceuticals

Vaxigrip: Sanofi Pasteur

Reports of febrile convulsions

presenting to PMH ED follow TIV

Saba vaccinated

23rd April: national

suspension child

influenza program

SAEFVIC PRR

Fever signal detected 2 weeks from start of program

Detecting unsafe vaccines faster

Passive Surveillance Data consistency and

flow

New technologies

near-real time analyses

Better and near-real time use existing data,

syndromic surveillance

Acknowledgements SAEFVIC team

Hazel Clothier

Yonatan Mesfin

Jock Lawrie

Nigel Crawford

Allen Cheng

AusVaxSafety

Kristine Macartney

Nick Wood

Alan Leeb

Alexis Pilsbury