Novartis vaccine recalled after contamination scare
pharmafile | February 26, 2009 | News story | Manufacturing and Production, Research and Development |Â Â VaccineÂ
Novartis has recalled UK supplies of its meningitis C vaccine after tests found some batches contaminated with bacteria.
The recall involves over 20,000 doses of the Menjugate Kit vaccine, which is routinely given to four month old babies, with around double this amount in storage also potentially affected.
Novartis say the batches which tested positive for the Staphylococcus aureus bacteria had been detected during a shipping validation study after they left a manufacturing site in Siena, Italy and were transported by air.
The study was conducted to test whether the sample would remain biologically secure under the varying air pressure of air transportation. But the MHRA pointed out the UK's vaccines have been transported by road, suggesting that these supplies have not been exposed to the same risk.
The company and UK medicines regulator the MHRA said the two UK batches already distributed to general practices were being recalled as a purely precautionary measure, and that there was no reason to suspect that any children have been affected.
Nevertheless, the presence of the bacteria in some supplies is potentially very hazardous, and government officials will hope the recall will not undermine parent's faith in the safety of the vaccine.
Unfounded allegations published in 1998 which claimed the MMR vaccine caused autism in some children created the UK's most infamous scare over vaccine safety, and immunisation levels have still not recovered.
The meningitis C vaccine was first introduced in 1999, and has helped cut cases of the frequently fatal virus by more than 95%.
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