[NVIC] UK babies sick from TB vaccine.

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-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTERVienna, Virginia http://www.nvic.org* * * * * * * * * * * * * * * * * * * * * * * UNITED WAY/COMBINED FEDERAL CAMPAIGN #8122* * * * * * * * * * * * * * * * * * * * * * *"Protecting the health and informed consent rights of children since 1982." ==========================================================================================http://www.timesonline.co.uk/article/0,,2091-2136412,00.htmlThe Sunday Times April 16, 2006Sick babies prompt fears over ‘new’ TB vaccine safetyJan BattlesA NEW version of the BCG vaccine

administered to newborns has led tocomplications in dozens of Irish babies, prompting doctors to question itssuitability.Some of the infants needed surgery after severe reactions to the new strainof the inoculation designed to combat tuberculosis (TB).The vaccine was introduced in 2002 when the previous strain became lesseffective at building immunity. Under the national immunisation programme,the BCG — which contains live TB organisms — is usually given on the day ababy 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 TempleStreet, Dublin’s two children’s hospitals, undertook a study after threeinfants were admitted in quick succession with complications soon after thenew strain was introduced.One was an

otherwise healthy seven-week-old baby girl who had “severeprotracted complications” that required several operations.As well as developing abscesses at the inoculation site, the infantssuffered secondary infections in their lymph nodes, mainly in their armpits.The glands were becoming filled with pus. When drainage and antibioticsproved 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 casesof BCG-related complications referred to either hospital. They found thatbetween August 2002, when the new vaccine was introduced, and July 2004, atotal of 58 babies were treated for severe reactions to the inoculation. Ofthese, 26 required surgery, with three babies requiring more than oneprocedure. 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 surgicalintervention — was of concern. Turlough Bolger, paediatric registrar in theinfectious diseases service at Our Lady’s hospital for Sick Children,Crumlin, said: “While we would expect a certain amount of reaction, and infact reactions are a good thing because it means that you’re responding tothe vaccine, these were excessive.”“This new vaccine was much more potent so you have to be very precise aboutwhere you put the needle,” said Bolger. “That may have been part of theproblem.”As a result of the cases, an advisory notice was issued reiterating thedosage size and correct way to administer the vaccine. A national meeting ofpublic health staff was convened urgently to demonstrate the correctprocedure for inoculating newborns and an intense education programme hasbeen put in

place.Bolger said re-educating healthcare workers had led to a marked reduction inthe number of severe reactions. “There is increased awareness among thepeople giving the vaccines that there is a problem with this vaccine and youhave to be very careful giving it. The reaction numbers have gone downsince.”TB in children is still a significant problem, Bolger said. Most cases arisein children who have been exposed to elderly relatives who had reactivatedTB from their childhood and passed on the disease through coughing.=============================================News is a free service of the National Vaccine InformationCenter and is supported through

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