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Important Information -  CSL's Panvax® H1N1 2009 Junior vaccine: shelf life reduction

Ongoing monitoring by both CSL and the TGA of CSL's Panvax® H1N1 2009 Junior vaccine has shown a decline in potency and as a result a 12 month shelf life can no longer be supported. Similar trends have been identified with other manufacturers' 1-I1N vaccines. The decline in potency is specific to monovalent Hi N 1 vaccine when presented in small volumes, such as Panvax® Junior vaccine, which is supplied in a 0.25mL pre-filled syringe. Panvax® (and other H1N1 vaccines) in multi-dose vials are not affected.

Based on this information and following consultation with the TGA, CST., has made the decision to lirnit the shelf life of the Panvax® I-HN.1 2009 Junior vaccine to 6 months and as a result, all remaining stock should now be considered expired.

To ensure the vaccine is no longer administered, CSL will be conducting a retrieval of all stock of Panvax® HiNi 2009 Junior vaccine from immunisation providers and vaccine distribution points. CSL Customer Service will directly contact providers who have received Panvax® Junior pre-filled syringes to arrange pick up.

Importantly, no unexpected safety or efficacy concerns have been identified with administration of Panvax® Junior vaccine presentation. Panvax® Junior has been available for children aged 3 years and under since 9th December, 2009 and approximately 400,000 doses have been distributed. Advice regarding influenza vaccinations for children is available at www.healthemergcy.gov.au and www.immunise.health.gov.au.   

Should you require additional information, please contact CSL Biotherapies Medical Information on 1800 642 865 or the Immunise Australia Information Line on 1800 671 811. 

 

GP REGISTRATION

Currently faults are being experienced on national registration website. It seems that if you enter your state (ie NSW) that your name will not be searchable.  

 

CHILD PROTECTION LEGAL OBLIGATIONS

On 24 January 2010 GPs' & the Divisions clinical staff legal obligation as child protection mandatory reporters changed with the commencement of a new reporting threshold.

Concerns about possible abuse or neglect of a child or young person and suspicion, on reasonable grounds, that the child or young person is at `risk of significant harm' is to be reported to the Community Services' Child Protection Helpline, 133 627. This new reporting threshold has replaced 'risk of harm' in the Children and Young Persons (Care and Protection) Act 1998.  

The NSW Mandatory Reporter Guide (MRG) is a structured decision making tool to assist mandatory reporters, to decide whether or not a child or young person is at risk of significant harm. The MRG and new interagency guidelines, "Making a Child Protection Report what to do when Children and Young People are at Risk of Significant Harm', are available online at: www.keepthemsafe.nsw.gov.au

 

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