The Independant Report Forces Meningitis Vaccine Withdrawl.

[Guest guest]

The Independent

26 February 2009

Questions over vaccine safety

By Steve Connor, Science Editor

 

 

 

Health officials have been forced to withdraw 21,000 doses of the

meningitis C vaccine from GP clinics around the UK after it emerged

that some doses may have been contaminated with a blood-poisoning

bacterium.

 

More than 60,000 doses of the vaccine, which is offered to all

four-month-old babies, could be contaminated with the hospital-acquired

infection – the Staphylococcus aureus bacterium – and a third of these

had already been sent to vaccination clinics before officials became

aware of the problem.

 

Officials within the Department of Health and the vaccine's

manufacturers are believed to have known of the problem since Tuesday

but only issued an emergency recall last night after being contacted

about the potential contamination by The Independent.

 

Last night the Tory health team demanded answers about why it had taken

so long to withdraw the vaccine and said there may need to be an

inquiry. It is not known how many children may have received the dose,

but one official said that there have as yet been no reports of any

adverse reactions.

 

In a statement, the Department of Health denied that any contaminated

samples had entered the UK market. "Two batches have been identified

and are being recalled as a purely precautionary measure. These two

batches passed all routine quality testing, including a sterility test."

 

The revelation comes at a critical time given that many parents are

still suspicious about childhood vaccinations due to the unfounded

scare over the measles, mumps and rubella (MMR) vaccine which was

incorrectly linked to autism in a study published over 10 years ago and

since retracted.

 

The meningitis C vaccine, sold under the trade name Menjugate, is

manufactured and packed in Italy by Novartis, a multinational

pharmaceutical company. One insider told The Independent that any

contamination with Staphylococcus – which is related to MRSA – would

have occurred during the preparation of the vaccine in the

manufacturing centre in Siena.

 

The company confirmed last night that two lots of the vaccine – some

61,117 doses imported into Britain – could be contaminated and that

21,301 doses have been sent to GP surgeries over the past week for the

Government's childhood vaccination programme.

 

The Medicines and Healthcare products Regulatory Agency (MHRA) was

working last night with Novartis to recall all the remaining doses of

vaccine that had been sent to GPs but which had not yet been used. A

spokeswoman for Novartis said that the company's press office was made

aware of the problem on Monday but she could not say when the company

had informed the Department of Health.

 

"Novartis is working with the relevant government authorities including

the MHRA and the Italian Ministry of Health to recall two lots of

Menjugate distributed in the UK," the spokeswoman said.

 

"We are investigating a sterility testing positive result from samples

of one lot of aluminium hydroxide solvent which was used in the

packaging of two lots of Menjugate. The solvent lot passed all release

specifications. The subject result was identified during a special

study," she said.

 

The MHRA said in a statement issued last night that it was first

alerted to the problem on Tuesday. "The tested samples were of one

batch of solvent used in two batches of Menjugate Kit, and were

identified positive for the bacteria Staphylococcus aureus during the

sterility test. They [the two samples] were not distributed to the UK

market," it said.

 

"However, as a precaution, these two batches of Menjugate Kit which

were distributed in the UK are being recalled. There is at present no

evidence that these two batches of Menjugate Kit are affected," it

added.

 

A spokeswoman for the MHRA said that, despite the recall, there was no

evidence of any risk to children from the vaccine but she could not say

how many babies could have already been injected with the vaccine. "The

recall is purely a precautionary measure. There is no reason for UK

children to be at any risk from this product. All vaccine supplied to

the UK had passed the tests required for its use," she said.

 

Andrew Lansley, the shadow Health Secretary, said: "This is very

disturbing news. We will be looking to the Government to give the

fullest possible account of what's happened.

 

"Parents who bring their children for immunisation need to have the

greatest possible confidence that the vaccines concerned are safe and

their children won't come to harm. I will be looking to the Government

to provide this specific assurance."

 

Mike Penning, a Tory health spokesman, said: "Parents take vaccines to

make their children safe, not put them at risk. They will want answers

as to why it took so long to withdraw the vaccine. The Government has

got to come clean about its decision-making and when the Secretary of

State was told what happened. We could need an independent inquiry to

establish the facts."

 

The Menjugate vaccine – one of two distributed in the UK – was the

subject of safety concerns in 2000 soon after it was introduced into

Britain. However, the Medicines Control Agency said at the time that

the fears were unfounded.

 

Pat Troop, then deputy chief medical officer, said in 2000 the

meningitis C vaccine was very safe. The number of adverse reactions –

such as headaches, and sore arms – were normal for this sort of

vaccine, she said.

 

Novartis: The company behind the jab

 

The Swiss pharmaceutical giant Novartis is one of the largest medicine

manufacturers in the world with 81,000 employees operating in 140

countries. It was formed out of the merger in 1996 of two "big

pharmas", Ciba-Geigy and Sandoz. In 2006, Novartis acquired the

US-based vaccine supplier Chiron Corporation. Two years earlier,

Britain's Medicines and Healthcare Products Regulatory Agency seized

more than 48 million doses of Fluvirin, an influenza vaccine made in

Chiron's factory in Liverpool, over concerns they were contaminated.

The seizure caused a major shortage of flu shots in the US market in

which Chiron had a near monopoly. Nonetheless the vaccine market has

remained a strong moneyspinner for Novartis. Last month the US

government awarded it a $486m (£342m) contract to build a factory to

produce a cell-based influenza vaccine which would be capable of

churning out 150 million flu shots within six months of Washington

declaring a flu pandemic. In Britain over the past two years Novartis

has been trying to create a vaccine for meningitis B, which kills more

than 100 children every year. Novartis, the Health Protection Agency

and the Oxford Vaccine Group have been carrying out a joint trial on

three different strains of meningitis B with positive results. Novartis

expects to apply for a licence next year and hopes to have it on the

market by 2011. Currently 10 per cent of the children with meningitis B

die and 15 per cent of those who survive are left with severe

disabilities.

 

Jerome Taylor

 

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