[NVIC] UK babies sick from TB vaccine.

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http://www.timesonline.co.uk/article/0,,2091-2136412,00.html

The Sunday Times April 16, 2006

Sick babies prompt fears over ‘new’ TB vaccine safety

Jan Battles

A NEW version of the BCG vaccine administered to newborns has led to

complications in dozens of Irish babies, prompting doctors to question

its

suitability.

Some of the infants needed surgery after severe reactions to the new

strain

of the inoculation designed to combat tuberculosis (TB).

The vaccine was introduced in 2002 when the previous strain became less

effective at building immunity. Under the national immunisation

programme,

the BCG — which contains live TB organisms — is usually given on the

day a

baby is born. A booster is administered in the early teens if

necessary.

While it is normal for babies to have mild reactions at the injection

site,

these should clear up within 12 weeks. But doctors at Crumlin and

Temple

Street, Dublin’s two children’s hospitals, undertook a study after

three

infants were admitted in quick succession with complications soon after

the

new strain was introduced.

One was an otherwise healthy seven-week-old baby girl who had “severe

protracted complications” that required several operations.

As well as developing abscesses at the inoculation site, the infants

suffered secondary infections in their lymph nodes, mainly in their

armpits.

The glands were becoming filled with pus. When drainage and antibiotics

proved to be ineffective, these had to be operated on.

The doctors notified the health department and the Irish Medicines

Board

(IMB) of potential problems with the vaccine and began monitoring all

cases

of BCG-related complications referred to either hospital. They found

that

between August 2002, when the new vaccine was introduced, and July

2004, a

total of 58 babies were treated for severe reactions to the

inoculation. Of

these, 26 required surgery, with three babies requiring more than one

procedure. The others were given antibiotics.

The authors of the study, published in Archives of Disease in

Childhood,

said the severity of the reactions — with 45% requiring surgical

intervention — was of concern. Turlough Bolger, paediatric registrar in

the

infectious diseases service at Our Lady’s hospital for Sick Children,

Crumlin, said: “While we would expect a certain amount of reaction, and

in

fact reactions are a good thing because it means that you’re responding

to

the vaccine, these were excessive.”

“This new vaccine was much more potent so you have to be very precise

about

where you put the needle,” said Bolger. “That may have been part of the

problem.”

As a result of the cases, an advisory notice was issued reiterating the

dosage size and correct way to administer the vaccine. A national

meeting of

public health staff was convened urgently to demonstrate the correct

procedure for inoculating newborns and an intense education programme

has

been put in place.

Bolger said re-educating healthcare workers had led to a marked

reduction in

the number of severe reactions. “There is increased awareness among the

people giving the vaccines that there is a problem with this vaccine

and you

have to be very careful giving it. The reaction numbers have gone down

since.”

TB in children is still a significant problem, Bolger said. Most cases

arise

in children who have been exposed to elderly relatives who had

reactivated

TB from their childhood and passed on the disease through coughing.

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