Table 5.

Summary of Policy Reports

Study Characteristics						Reported Adverse Events			Recommendations
Ref, Year	CTR	National TB incidence (at the time of study)	Study Pop	Current / prior BCG policy	New policy	Event	Inc Cont n/N	Inc Int n/N	Target population / risk group	Observations and General Recommendations
[19], 2006	Canada		Canadian Indigenous communities	Vaccination remains in some Indigenous communities only (discontinued in others since 2004)		Disseminated BCG infection	7 cases from 1993 to 2003 (6 fatal) in First Nations communities across Canada (all had an underlying immunodeficiency)		Communities with: - Average annual rate of smear positive pulmonary TB > 15/100000 in previous 3 years, or - Annual risk of TB infection > 0.1%, - Average annual notification rate of paediatric TB meningitis is > 1/10 million in children under 5 in the last 5 years	Should not be withdrawn in communities who continue to have high TB incidence. Consider withdrawal for low-risk communities. Readiness for withdrawal requires an effective surveillance system for monitoring of subsequent incident cases. Implications of withdrawal: As of 2006, 5 communities in the Sioux Look out zone met the criteria for high-risk (see left), and would thus be at risk for further TB transmission if BCG is withdrawn.
[64], 1994	UK	NR	General UK population	Routine vaccination in school programs					- Healthcare and prison staff, - Children of immigrants from high-prevalence countries, - Child or young adult contacts of active TB cases identified via contact tracing, - Babies of mothers with pulmonary TB	Routine vaccination of 10–14 year olds in schools (policy to be reviewed in 1995. In addition, vaccination of healthcare and prison staff, children of immigrants from high-prevalence countries, and child or young adult contacts of active TB cases. Babies of mothers with pulmonary TB should be vaccinated in the case of a negative TST six weeks after chemoprophylaxis.
[29], 1995	USA		US General population	NR						Routine vaccination is not recommended in the US. The primary strategy for TB control focuses on the identification and treatment of active cases, and the second priority is the identification of LTBI. BCG Vaccination should be considered among children with negative TSTs if they are in contact with an active TB case.
[65], 2006	France			Routine vaccination before entry into day-care	Selective vaccination of high-risk groups begun in 2004	BCGitis	Approx. 12 cases in total in France per year			At 50% efficacy for preventing all forms of TB in children under 15, 320 additional cases of childhood TB would occur if routine vaccination is stopped, however, 240 of these can be prevented by selective vaccination of only 15% of the child population, which would therefore also prevent 85% of BCG associated adverse events, and 11 of the 12 cases of BCGitis per year. Selective vaccination is therefore recommended, but caution is advised to ensure appropriate coverage of target populations. Revaccination: Not recommended (no evidence of efficacy)
[66], 2012	Australia	5.28 and 5.95 cases per 100,000 population in 2005–2009	General population of Australia	Selective vaccination of high-risk groups					- Aboriginal and Torres Strait Islander neonates in communities with a high incidence of TB; - Neonates and children 5 years of age and under who will be travelling to or living in countries or areas with a high prevalence of TB for extended periods; - Neonates born to parents with leprosy or a family history of leprosy.	Most TB cases (80–90%) are among immigrants from high-prevalence countries. Selective vaccination is therefore used. Vaccination is recommended for:1. Aboriginal and Torres Strait Islander neonates in communities with a high incidence of TB;2. Neonates and children 5 years of age and under who will be travelling to or living in countries or areas with a high prevalence of TB for extended periods;3. Neonates born to parents with leprosy or a family history of leprosy. BCG vaccination may be considered in Children over 5 years of age who will be travelling to or living in countries or areas with a high prevalenceof TB for extended periods; Revaccination: Not recommended
[47], 1996	UK		High-incidence communities in the UK	NR						Selective vaccination in high-incidence communities (over 40 cases per 100,000) as well as of immigrants from endemic areas may be of interest, although this is more difficult to implement effectively, as a universal vaccination program would reduce the number of eligible people missed
[33], 2011	Canada	4.8/100,000	Canadian First nations population	Routine vaccination discontinued in Alberta, Saskatchewan, Quebec and some Ontario First Nations communities (Moose Factory and Thunder Bay Zones) between 2003 and 2005.		Disseminated BCG infection	6 cases between 1993 and 2003 (estimated rate: 205 cases per million doses)		- Infants in First Nations and Inuit communities or infants in communities with an average annual rate of smear-positive pulmonary TB greater than 15 per 100,000 population in the past 3 years, or - Infants residing in populations with an annual risk of TB infection greater than 0.1%, (if early identification and treatment of TB infection are not available.)	The 2011 Report found no increase in TB meningitis or miliary TB since the discontinuation of routine vaccination. However, due to the small population sizes of first nations communities, incidence rates easily fluctuate above or below the National Advisory Committee on Immunisation (NACI) cut-offs (see left) and therefore perhaps make these of limited use in determining appropriate vaccination policy.
[45], 2014	Egypt	34 cases to 17 cases per 100,000 population (1992–2011)	General Egyptian population	Routine vaccination at birth (1992: 92%, 2006: 99%)						There was a significant correlation between vaccine coverage and TB incidence, prevalence, TB-associated mortality, and TB associated under five mortality in 1992–2011: (R, p value): 0.74 < 0.0001, 0.86 < 0.0001, 0.86 < 0.0001, 0.77 < 0.0001. Current routine vaccination therefore remains effective.
[31], 2006	Finland	6.6/100000 in 2004	General Finnish population	Routine vaccination at birth (98%)	Targeted vaccination among high-risk groups (planned to begin 2008)	BCG osteitis	2 cases in 2002	6 cases in 2003	- Children of immigrant families from high-incidence countries - Children of Finnish-born parents with a family history of TB - Children of families planning to stay for a prolonged period in a high-incidence country - Upon request by the parent	In Finland, most TB cases are among seniors (65 or older) and the Indigenous population (rather than among immigrants, as is the case in many other European countries).
[46], 2007	UK			Vaccination of all secondary school children	Targeted BCG vaccination both in neonates and opportunistically in older children				- Infants attending primary care in areas with a high incidence of TB Infants who: - Were born in an area with a high incidence of tuberculosis, or - Have one or more parents or grandparents who were bornin a high-incidence country (>  40 cases per 100,000 per year), or - Have a family history of tuberculosis in the past 5 years. Children younger than 16 who also meet these risk criteria should be opportunistically vaccinated.	See target groups
[32], 1994	Finland		Finnish General population	NR (50–80%)						Necessities before discontinuation (International union against TB and lung disease): - Strong, established TB control program for TB case data over past 5 years, - Knowledge of the impact of HIV prevalence in the population on TB transmission - Incidence of smear-positive TB no more than 5 / 100,000 in past 3 years, or - < 1 per 10,000,000 cases of TB meningitis in children under 5 in the last 5 years, or - Annual risk of TB 0.1% or less. Implications of withdrawal: discontinuation of mass vaccination resulted in an increase of TB in Sweden1 and in former Czechoslovakia Revaccination: Not recommended
[6], 2001	Global	Varied		Varied						International Union against Tuberculosis and LungDisease recommends that a country should only move from universal to targeted vaccination if: - An efficient system of case notification is established- The average annual notification rate of smear-positive pulmonary tuberculosis is < 5 per 100,000;or - The average annual notification rate of TB meningitis in children aged < 5 years is < 1 per 10 million population over the previous 5 years, or the average annual risk of TB infection is < 0.1% Revaccination: Not recommended

Cont Control, CTR Country, Inc Incidence, Int Intervention, NR Not reported