Meningitis vaccine for babies recalled over contamination fears

[Nostalgia]

Meningitis is the bacterial or viral inflammation of the brain's membranes

Britain's medicines watchdog has authorised the recall of 21,000 doses of a Meningitis C vaccine used to immunise young babies due to contamination fears.

The drugs are part of 60,000 single doses ordered by the Department of Health as part of its routine Meningitis C (MenC) vaccination programme for all three and four-month-old babies.

The affected batches of the vaccine, which is sold under the trade name Menjugate, were delivered by the manufacturer, Novartis Vaccines, in January and February. So far 21,000 doses have been sent out to GPs and clinics.

The Department of Health said it had received no reports of adverse reactions among babies to the MenC vaccine, either now or in the past. It, the MHRA and Novartis have all issued assurances that the recall is purely precautionary and there is "no evidence" that the vaccine is tainted or poses a risk to health.

The recall is nonetheless likely to reawaken parents' fears about the safety of the Government's vaccination programme, fears which have yet to fade completely since the mistaken alarm over the combined Measles Mumps and Rubella vaccine for children.

“When parents take their children for vaccinations it is essential that they are confident that the vaccine is safe," said Andrew Lansley, the Shadow Health Secretary. “I hope that ministers will provide that reassurance as quickly as possible.”

Novartis, which manufactures the vaccine in Italy, said it had discovered traces of Staphylococcus Aureus in the aluminium hydroxide solvent in which the vaccine is suspended, during tests on other vials - made at the same time - which had as an experiment been sent by air, rather than by road as they were to Britain. The Staphylococcus Aureus bacterium is associated with blood poisoning and skin infections.

The Novartis press office was reportedly made aware of the issue on Monday. Nonetheless it was Tuesday before the company s contacted the Medicines and Healthcare products Regulatory Agency (MHRA), admitting to the problems and saying it wished to recall the rest of the vaccine. The MHRA issued a drug alert to pharmacies at 6.30pm last night, more than 48 hours later.

An MHRA spokesman told Times Online that it appeared that sending the vaccine in a pressurised aircraft cabin may have caused the contents of the test vials to expand, allowing contamination to enter.

“Further investigations into the cause of the failure are under way by the company. There is currently no evidence to show that there is any risk to children,” said the medicines watchdog.

“The tested samples that failed the sterility test were part of a non-routine study undertaken by the company and were not part of the UK market product.”

So far, roughly a third of the 60,000 vials are believed to have been distributed from storage warehouses to doctors’ surgeries around the country. It is not known how many babies have so far been vaccinated using doses from the affected batches.

A Department of Health spokeswoman stressed that the recall was precautionary and that it was not aware of any baby suffering an adverse reaction to the vaccine. The two British batches will now be subjected to further tests to allow comparisons to be drawn. Results are due back in a few days' time.

“All batches of the vaccine that have come into the UK have passed all their tests, including sterility," said a Department of Health spokeswoman.

"If people have had this vaccine recently and are concerned, contact your GP or NHS Direct.”

Meningococcal group C is a type of bacteria that can cause meningitis and septicaemia. The MenC vaccine does not protect against meningitis caused by other bacteria or by viruses.

Novartis has been on the main suppliers of the vaccine to the Department of Health ever since Britain's MenC vaccination programme began in 1999.

All babies are given a dose of MenC vaccine at the age of three or four months. At age 12 months they are given a combined Hib and MenC vaccine.

The Department of Health said it had not heard of any previous safety issues with the MenC vaccine.

Novartis issued a statement last night saying that it was "working with the relevant government authorities, including the MHRA and the Italian Ministry of Health, to recall two lots of Menjugate Kit distributed in the UK".

It went on: “We are investigating a sterility testing positive result from samples of one lot of Aluminum hydroxide solvent which was used for the packaging of two lots of Menjugate.

“The solvent lot passed all release specifications; the subject result was identified during a special study.”

No-one from the company was available this morning to elaborate on the statement.

http://www.timesonline.co.uk/tol/new...cle5807660.ece