Sick babies prompt fears over ‘new’ TB vaccine safety

Jan Battles
The Sunday Times April 16, 2006,,2091-2136412,00.html

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.