RECALL - Meningitec meningococcal serogroup C conjugate vaccine

By Petrina Smith
Tuesday, 30 September, 2014



Health professionals are advised that Emerge Health, in consultation with the TGA, is recalling all unexpired doses of Meningitec meningococcal serogroup C conjugate vaccine suspension for injection, single dose syringe, due to the potential for particulate contamination.
Meningitec meningococcal serogroup C conjugate vaccine is used to prevent meningococcal disease caused by meningococcal C bacteria.
Emerge Health has advised that a review of batches manufactured since October 2012 found a small number of syringes had been contaminated with iron oxide (rust) and oxidised stainless steel, both of which originated from manufacturing equipment. The review was prompted by two European reports of particulate matter in the syringes.
The risk that an individual in Australia has received a contaminated dose of vaccine is very low. Only a small number of doses per batch were found to be contaminated and the presence of iron oxide would be readily visible during a pre-vaccination visual inspection of the vial, as specified in the Australian Immunisation Handbook. If contamination was identified, the vaccine would not be administered.
There have been no reports to the TGA of particulate matter in the syringes supplied in Australia or any increase in adverse event reports that could be attributable to this issue.
Emerge Health has advised that the contamination did not affect sterility.
As part of a worldwide recall, in Australia all unexpired batches of Meningitec are being recalled.
No other meningococcal serogroup C conjugate vaccines are affected by this recall.
If you, or the facility you work for, have any stocks of Meningitec quarantine them and contact Emerge Health to arrange for their return. Please note that all batches supplied in Australia identify Pfizer as the sponsor of Meningitec.
Alternative meningococcal C conjugate vaccines are listed in the Australian Immunisation Handbook.
Estimates provided to the TGA by the sponsor indicate that the amount of iron oxide found in a contaminated syringe could be up to a maximum of 105 mg, with an estimated elemental iron amount of about 70%. This amount of iron oxide would be readily visible during a pre-vaccination visual inspection of the vial.
Administration of an affected dose may result in an increased risk of local injection site reactions (redness, pain, swelling, discolouration of the skin) or allergic responses. If administered to a baby less than 7kg in weight there is a potential risk of iron toxicity.
There have been no reports to the TGA of particulate matter in the syringes supplied in Australia or any increase in adverse event reports that could be attributable to this issue.
The TGA reminds health professionals to 'inspect before you inject'. As specified in the Australian Immunisation Handbook, all vaccine should be checked visually prior to administration.

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