During a shipping test Staphylococcus aureus was detected in the batch of aluminium hydroxide solvent that was used in the preparation of the two lots. No contamination was detected at the time of the solvents release.
Novartis is now investigating the root cause of the solvent contamination and neither it, nor the Medicines and Healthcare Regulatory Agency (MHRA), have any evidence that any other batches are affected.
The MHRA has also stated that the two vaccine batches distributed in the UK passed all import tests, including one for sterility, and that the recall is merely precautionary. It is believed that around 20,000 doses will be recalled.
Novartis meningitis C vaccine, which is sold under the name Menjugate Kit, is manufactured in Italy and has been on the market in the UK since January.
Vaccine safety scares big issue in UK
Public concern about the safety of vaccinations, inflamed by the media and the alleged link between autism and the measles mumps and rubella (MMR), means safety issues generate significant column inches.
Worries about vaccines have faded slightly in the UK in recent years but nonetheless it remains a significant issue for many people and therefore carries political significance.
Andrew Lansley, UK shadow Health Secretary, has already commented on the issue in the UK’s Telegraph, saying: “This is very disturbing news. We will be looking to the Government to give the fullest possible account of what’s happened.”