FW: GSK -advice re Leaky Syringes-January 2019

[Michael Wishart]

[Posted on behalf of Kelly Barton Moderator]

FYI.

I have had this happen on many occasions and did report it to GSK. The rate would be much higher than 37 per million.

Kelly

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Kelly Barton
Infection Prevention & Control Officer
Email: kelly.barton@alpinehealth.org.au
Office: 03 5751 9364
Mobile: 0409 885 002
Fax: 03 5751 9396
Address: 30 ODonnell Ave, Myrtleford VIC 3737
Website: http://www.alpinehealth.org.au
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From: Ryan.Swemmer@dhhs.vic.gov.au [mailto:Ryan.Swemmer@dhhs.vic.gov.au] On Behalf Of Immunisation@dhhs.vic.gov.au
Sent: Tuesday, 29 January 2019 3:54 PM
Subject: GSK -advice re Leaky Syringes-January 2019

Dear Colleagues

Please see attached a letter of advice from GSK, regarding Leaky Syringes, observed in a number of countries with some GSK vaccines.

On occasion, a very small volume of vaccine has leaked from some syringes, at an observed rate of 37 reported leakages per million syringes distributed.

The leakage does not pose a concern for sterility assurance, but the potential risk associated with leakage of vaccine from the syringe is that it could, in theory, result in under-dosing.

A review of GSKs pharmacovigilance data shows no evidence that the observed leakage has resulted in vaccination failure (lack of efficacy) or any other patient safety concern.
The syringes that are the subject of this letter are in the process of being substituted with improved syringes, and the majority of potentially impacted products will be depleted by the end of 2019. As the re-supply of vaccines with improved syringes commences, the observed rate is expected to progressively decrease.

Any reports of leaky syringes should be directed to the GSK Medical Information team on 1800 033 109.

Kind regards

Immunisation Unit

Immunisation Unit | Health Protection Branch
Regulation, Health Protection & Emergency Management Division
Department of Health and Human Services | 50 Lonsdale Street, Melbourne, Victoria, 3000
P:1300 882 008 | E: immunisation@dhhs.vic.gov.au | F: 1300 768 088
www2.health.vic.gov.au/public-health/immunisation

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