Meningococcal vaccine recalled
Australia is part of a worldwide recall of a meningococcal vaccine following reports batches have been contaminated with rust and stainless steel.
Drug company Emerge Health is working with the Therapeutic Goods Administration to retrieve all unexpired doses of its Meningitec meningococcal serogroup C conjugate vaccine suspension, sold as a single dose syringe.
The global recall was initiated after a small number of syringes in Europe were found to have been contaminated with particles of iron oxide and oxidised stainless steel from manufacturing equipment.
The TGA said the risk that anyone in Australia had received a contaminated dose was “very low” because the number of syringes affected was small, and the rust particles would be readily seen in any pre-vaccination inspection of the vials of the vaccine.
It said the incident underlined the importance of Health Department advice to “inspect before you inject”.
Patients injected with the contaminated serum might experience some pain, redness or swelling around the vaccination site, while there is a potential risk of iron toxicity in babies weighing less than seven kilograms.
But the watchdog said it had not received any reports that vials of vaccine in Australia had been contaminated, and there had not been any increase in adverse event reports that could stem from this issue.
Health professionals who find they have stocks of Meningitec, sponsored by Pfizer in Australia, are asked to place them in quarantine and contact Emerge Health to arrange their return.
The TGA said no other meningococcal serogroup C conjugate vaccines are affected by the recall.