<str<strong>on</strong>g>Guidel<strong>in</strong>es</str<strong>on</strong>g> <strong>on</strong> <strong>the</strong> Preventi<strong>on</strong> <strong>and</strong> C<strong>on</strong>trol <strong>of</strong> <strong>Tuberculosis</strong> <strong>in</strong> Irel<strong>and</strong> 2010HSE/HPSCor• The average annual notificati<strong>on</strong> rate <strong>of</strong> TB men<strong>in</strong>gitis <strong>in</strong> children under five years <strong>of</strong> age should beless than <strong>on</strong>e case per ten milli<strong>on</strong> general populati<strong>on</strong> over <strong>the</strong> previous five yearsor• The average annual risk <strong>of</strong> TB <strong>in</strong>fecti<strong>on</strong> should be 0.1% or less. This is not applicable to Irel<strong>and</strong>.The nati<strong>on</strong>al rate for sputum smear positive pulm<strong>on</strong>ary TB has been under 5 per 100,000 for <strong>the</strong> threeyears prior to 2006. In 2005 <strong>the</strong> rate was 3.3 per 100,000, while <strong>in</strong> 2004, 2003 <strong>and</strong> 2002, <strong>the</strong> rates were3.5 per 100,000, 3.7 per 100,000 <strong>and</strong> 3.1 per 100,000 respectively. However, data from between 2001 <strong>and</strong>2006 <strong>in</strong>dicate that <strong>the</strong>re were four cases <strong>of</strong> TB men<strong>in</strong>gitis notified <strong>in</strong> children aged less than five years, <strong>of</strong>whom two were culture positive <strong>and</strong> three had not received BCG vacc<strong>in</strong>e. 20When c<strong>on</strong>sider<strong>in</strong>g <strong>the</strong> importance <strong>of</strong> ne<strong>on</strong>atal BCG vacc<strong>in</strong>ati<strong>on</strong>, it is worth c<strong>on</strong>sider<strong>in</strong>g <strong>the</strong> practice <strong>in</strong>o<strong>the</strong>r European countries. For example, Sweden disc<strong>on</strong>t<strong>in</strong>ued rout<strong>in</strong>e ne<strong>on</strong>atal BCG vacc<strong>in</strong>ati<strong>on</strong> <strong>in</strong> 1975when <strong>the</strong>y had a total notificati<strong>on</strong> rate <strong>of</strong> 20 per 100,000 populati<strong>on</strong> <strong>and</strong> an age-specific <strong>in</strong>cidence ratefor children aged 0-14 years <strong>of</strong> 0.3 per 100,000. While <strong>the</strong> nati<strong>on</strong>al crude rate <strong>in</strong> Irel<strong>and</strong> is less than 20 per100,000 populati<strong>on</strong>, <strong>the</strong> 2006 age-specific <strong>in</strong>cidence rate for children 0-14 years was 2.4 per 100,000, eighttimes <strong>the</strong> rate recorded <strong>in</strong> Sweden when <strong>the</strong>y disc<strong>on</strong>t<strong>in</strong>ued ne<strong>on</strong>atal BCG vacc<strong>in</strong>ati<strong>on</strong>. In 2005, 2004, 2003,2002, 2001 <strong>and</strong> 2000, <strong>the</strong> age-specific <strong>in</strong>cidence rate for children aged 0-14 years was 3.0 per 100,000,1.2 per 100,000, 2.9 per 100,000, 2.2 per 100,000, 1.9 per 100,000 <strong>and</strong> 1.9 per 100,000 respectively. In1999, <strong>the</strong> age-specific <strong>in</strong>cidence rate for children aged 0-14 years was 5.1 per 100,000 populati<strong>on</strong>, almostseventeen times <strong>the</strong> rate recorded <strong>in</strong> Sweden. In 1998, <strong>the</strong> corresp<strong>on</strong>d<strong>in</strong>g figure was 3.5 per 100,000populati<strong>on</strong> almost twelve times <strong>the</strong> rate recorded <strong>in</strong> Sweden when <strong>the</strong>y disc<strong>on</strong>t<strong>in</strong>ued BCG. 20It is also notable that F<strong>in</strong>l<strong>and</strong> who moved from a universal newborn BCG vacc<strong>in</strong>ati<strong>on</strong> programme to atargeted risk group programme <strong>in</strong> September 2006 had <strong>on</strong>ly five notified cases <strong>of</strong> TB <strong>in</strong> <strong>the</strong> 0-2 year oldsbetween 1997 <strong>and</strong> 2001 <strong>and</strong> no cases <strong>of</strong> TB men<strong>in</strong>gitis <strong>in</strong> <strong>the</strong> 0-14 year olds notified <strong>in</strong> this period. S<strong>in</strong>ce1970, <strong>on</strong>ly two cases <strong>of</strong> TB men<strong>in</strong>gitis have been notified nati<strong>on</strong>ally <strong>in</strong> F<strong>in</strong>l<strong>and</strong>. The nati<strong>on</strong>al <strong>in</strong>cidencerate for TB is 11 per 100,000 <strong>and</strong> 65% <strong>of</strong> cases occur <strong>in</strong> those aged over 60 years. Foreign-born patientsrepresent 6 to 9% <strong>of</strong> <strong>the</strong> total. 253When Canada disc<strong>on</strong>t<strong>in</strong>ued universal BCG <strong>in</strong> 2002, <strong>the</strong> nati<strong>on</strong>al TB notificati<strong>on</strong> rate was 5.2 per 100,000<strong>and</strong> <strong>the</strong> notificati<strong>on</strong> rate was 1.6 per 100,000 <strong>in</strong> 0-14 year olds. 254Also, rates <strong>of</strong> TB notificati<strong>on</strong>s <strong>in</strong> 1998 <strong>in</strong> <strong>the</strong> follow<strong>in</strong>g Nordic countries that have disc<strong>on</strong>t<strong>in</strong>ued ne<strong>on</strong>atalBCG programmes are much lower than <strong>in</strong> Irel<strong>and</strong> <strong>and</strong> am<strong>on</strong>g <strong>the</strong> best <strong>in</strong> <strong>the</strong> world as outl<strong>in</strong>ed below:• Sweden = 5.0 per 100,000• Norway = 5.0 per 100,000• Denmark = 9.6 per 100,000• Icel<strong>and</strong> = 5.8 per 100,000.As well as <strong>the</strong> IUATLD criteria, <strong>the</strong>re are additi<strong>on</strong>al c<strong>on</strong>siderati<strong>on</strong>s which should also be reviewed whendecid<strong>in</strong>g to modify or stop a universal BCG programme as outl<strong>in</strong>ed below:• Costs• Adverse reacti<strong>on</strong>s to BCG• Risk groups: In <strong>the</strong> event <strong>of</strong> disc<strong>on</strong>t<strong>in</strong>uati<strong>on</strong> <strong>of</strong> <strong>the</strong> BCG vacc<strong>in</strong>ati<strong>on</strong> programme for <strong>the</strong> generalpopulati<strong>on</strong>, it may be advisable to c<strong>on</strong>t<strong>in</strong>ue it <strong>in</strong> certa<strong>in</strong> well-def<strong>in</strong>ed populati<strong>on</strong> groups with aknown high notificati<strong>on</strong> rate <strong>of</strong> active TB. 253While Irel<strong>and</strong> meets <strong>the</strong> IUATLD criteria <strong>on</strong> <strong>the</strong> basis <strong>of</strong> overall smear positive pulm<strong>on</strong>ary TB report<strong>in</strong>grates, <strong>the</strong> number <strong>of</strong> TB men<strong>in</strong>gitis cases <strong>in</strong> children <strong>and</strong> general rates <strong>of</strong> TB <strong>in</strong> children rema<strong>in</strong> a c<strong>on</strong>cern.Also, <strong>the</strong> TB c<strong>on</strong>trol programme is currently under review <strong>and</strong> it is likely that recommendati<strong>on</strong>s will bemade for streng<strong>the</strong>n<strong>in</strong>g <strong>the</strong> programme. In light <strong>of</strong> <strong>the</strong>se f<strong>in</strong>d<strong>in</strong>gs, <strong>the</strong> c<strong>on</strong>t<strong>in</strong>uati<strong>on</strong> <strong>of</strong> <strong>the</strong> universalprogramme <strong>of</strong> ne<strong>on</strong>atal BCG vacc<strong>in</strong>ati<strong>on</strong> is recommended <strong>in</strong> Irel<strong>and</strong> at this time.-89-
<str<strong>on</strong>g>Guidel<strong>in</strong>es</str<strong>on</strong>g> <strong>on</strong> <strong>the</strong> Preventi<strong>on</strong> <strong>and</strong> C<strong>on</strong>trol <strong>of</strong> <strong>Tuberculosis</strong> <strong>in</strong> Irel<strong>and</strong> 2010HSE/HPSCRecommendati<strong>on</strong>:The c<strong>on</strong>t<strong>in</strong>uati<strong>on</strong> <strong>of</strong> a universal programme <strong>of</strong> ne<strong>on</strong>atal BCG vacc<strong>in</strong>ati<strong>on</strong> is recommended <strong>in</strong>Irel<strong>and</strong> at this time.7.3 Dose <strong>and</strong> Route <strong>of</strong> Adm<strong>in</strong>istrati<strong>on</strong>BCG Vacc<strong>in</strong>e Statens Serum Institut (SSI) is <strong>the</strong> <strong>on</strong>ly available licensed BCG vacc<strong>in</strong>e <strong>in</strong> Irel<strong>and</strong>. It c<strong>on</strong>ta<strong>in</strong>s<strong>the</strong> Danish stra<strong>in</strong> 1331. It does not c<strong>on</strong>ta<strong>in</strong> thiomersal or any o<strong>the</strong>r preservatives. It may be givenc<strong>on</strong>currently with ano<strong>the</strong>r live vacc<strong>in</strong>e, but if <strong>the</strong>y are not given at <strong>the</strong> same time an <strong>in</strong>terval <strong>of</strong> at least fourweeks should be allowed between such vacc<strong>in</strong>es. It can also be given at <strong>the</strong> same time as killed vacc<strong>in</strong>ese.g. DTaP/IPV/Hib/Hepatitis B, PCV (pneumococcal c<strong>on</strong>jugate vacc<strong>in</strong>e) or Men C.Recommendati<strong>on</strong>:When BCG is given to <strong>in</strong>fants <strong>the</strong>re is no need to delay <strong>the</strong> primary immunisati<strong>on</strong>s. No fur<strong>the</strong>rimmunisati<strong>on</strong> should be given <strong>in</strong> <strong>the</strong> arm used for BCG immunisati<strong>on</strong> for at least three m<strong>on</strong>thsbecause <strong>of</strong> <strong>the</strong> risk <strong>of</strong> regi<strong>on</strong>al lymphadenitis.Infants under 12 m<strong>on</strong>ths <strong>of</strong> ageThe recommended dose is 0.05ml by <strong>in</strong>tradermal <strong>in</strong>jecti<strong>on</strong> <strong>of</strong> <strong>the</strong> rec<strong>on</strong>stituted vacc<strong>in</strong>e at <strong>on</strong>e site over <strong>the</strong>middle <strong>of</strong> <strong>the</strong> deltoid muscle.Adults <strong>and</strong> children 12 m<strong>on</strong>ths <strong>and</strong> overThe recommended dose is 0.1ml by <strong>in</strong>tradermal <strong>in</strong>jecti<strong>on</strong> <strong>of</strong> <strong>the</strong> rec<strong>on</strong>stituted vacc<strong>in</strong>e <strong>and</strong> given at <strong>on</strong>esite over <strong>the</strong> middle <strong>of</strong> <strong>the</strong> deltoid muscle.Although <strong>the</strong> protecti<strong>on</strong> afforded by BCG vacc<strong>in</strong>e may wane with time, <strong>the</strong>re is no evidence that repeatvacc<strong>in</strong>ati<strong>on</strong> <strong>of</strong>fers significant protecti<strong>on</strong> <strong>and</strong> repeat BCG is not recommended. If re-immunisati<strong>on</strong> with BCGis be<strong>in</strong>g c<strong>on</strong>sidered expert advice should be sought.Detailed <strong>in</strong>structi<strong>on</strong>s <strong>in</strong>clud<strong>in</strong>g illustrati<strong>on</strong>s are available from <strong>the</strong> Immunisati<strong>on</strong> <str<strong>on</strong>g>Guidel<strong>in</strong>es</str<strong>on</strong>g> for Irel<strong>and</strong>prepared by <strong>the</strong> Nati<strong>on</strong>al Immunisati<strong>on</strong> Advisory Committee. 2557.4 Indicati<strong>on</strong>s for BCG Vacc<strong>in</strong>eRecommendati<strong>on</strong>:Tra<strong>in</strong><strong>in</strong>g for health pr<strong>of</strong>essi<strong>on</strong>als <strong>in</strong> <strong>the</strong> correct adm<strong>in</strong>istrati<strong>on</strong> <strong>of</strong> BCG vacc<strong>in</strong>e is recommended.Those adm<strong>in</strong>ister<strong>in</strong>g vacc<strong>in</strong>e should be aware <strong>of</strong> <strong>in</strong>dicati<strong>on</strong>s, c<strong>on</strong>tra<strong>in</strong>dicati<strong>on</strong>s, immunisati<strong>on</strong><strong>and</strong> adverse reacti<strong>on</strong>s associated with BCG.Groups <strong>in</strong> whom BCG vacc<strong>in</strong>e is <strong>in</strong>dicated:1. Newborn babies2. Unvacc<strong>in</strong>ated children aged <strong>on</strong>e to 15 years (i.e. those with no documented evidence <strong>of</strong> BCG orwithout a characteristic scar)i. Children aged three m<strong>on</strong>ths to less than six years who are not <strong>in</strong> an at-risk envir<strong>on</strong>ment5F1∏ do1 ∏ Children <strong>in</strong> at-risk envir<strong>on</strong>ments <strong>in</strong>clude those who are c<strong>on</strong>tacts <strong>of</strong> a pulm<strong>on</strong>ary TB case, who are from an area <strong>of</strong> high endemnicity(annual TB rates <strong>of</strong> ≥ 40/100,000) or whose parents are from an area <strong>of</strong> high endemnicity or who have household c<strong>on</strong>tacts who bel<strong>on</strong>gto an at-risk group for TB-90-