The Health Information and Quality Authority (HIQA) has today published a health technology assessment with advice to the Minister for Health on a change to Ireland’s BCG vaccination programme. HIQA has recommended a change from a universal to a selective national neonatal BCG vaccination strategy and advises that any change in strategy must be supported by a clear commitment to enhanced systematic and comprehensive tuberculosis (TB) control measures.

The evidence, Health technology assessment of a selective BCG vaccination programme, has been approved by the HIQA Board and presented to the Minister for Health.

HIQA’s Director of Health Technology Assessment Dr Máirín Ryan said: “A recommendation to switch to a policy of selective neonatal vaccination has been made based on the best available evidence. However, this is only recommended if appropriate preventative and protective measures are in place. If selective vaccination is adopted, the most efficient method of delivering the programme needs to be determined to ensure best use of available resources and to minimise the impact of discontinuing universal vaccination.”

HIQA’s health technology assessment advises that sufficient resources for enhanced TB control and public awareness efforts must be provided before there is any change in national vaccination policy and strategy.

Dr Ryan continued: “Selective vaccination would focus resources on those who are at higher risk of contracting TB; one in eight newborns will continue to be eligible for the vaccine. This includes infants born in, or whose parents are from, a country with a high incidence of TB, those in contact with patients with active respiratory TB, and members of an at-risk group, such as the Traveller community in Ireland. It would be important to consult with groups at higher risk to determine the most acceptable and efficient way to identify those eligible for vaccination.”

Today’s health technology assessment incorporates feedback from a public consultation and evaluates the clinical effectiveness and safety, cost-effectiveness and wider consequences of a change to selective vaccination, including ethical and social issues and the broader organisational impact.

Dr Ryan concluded: “The decision to advise the Minister to move from universal to selective vaccination was reached based on evidence in relation to declining TB incidence in Ireland, International Union Against TB and Lung Disease criteria for discontinuing universal BCG vaccination, and the incidence of BCG reactions. A selective vaccination programme would achieve a better balance between risks and benefits than the existing universal strategy, while continuing to protect those at higher risk from TB. Falling TB incidence has decreased the potential benefit of BCG vaccination for the majority of children. Selective vaccination would continue to protect those at higher risk while avoiding unnecessary side effects in those with a limited capacity to benefit from vaccination. Notwithstanding ongoing issues with the supply of the BCG vaccine, it is important that parents continue to get their children vaccinated until such time that the policy is changed and an enhanced programme of preventative measures is in place.”

Ends

Further Information: 

Marty Whelan, Head of Communications and Stakeholder Engagement, HIQA
01 814 7480 / 086 2447 623 mwhelan@hiqa.ie

Notes to the Editor: 

• Following a request under section 8(1) of the Health Act 2007 to undertake a health technology assessment in relation to proposed changes to the national neonatal BCG vaccination programme, HIQA assessed the impact of changing from a universal to a selective national neonatal BCG vaccination strategy.
• BCG stands for Bacillus Calmette-Guérin. The BCG vaccine SSI was authorised for use in Ireland by the former Irish Medicines Board in 2001, and has been used in the vaccination programme from July 2002.
• The number of cases of TB in Ireland each year has dropped from over 600 in the early 1990s to under 400 since 2012; 324 cases were reported in 2014. Between 2005 and 2014, the average annual number of cases in children aged less than 15 years was 20.9 cases, although the incidence has been in decline; the average annual number of cases for 2012 to 2014 was 11.7 cases.
• A range of TB control measures used in Ireland has contributed to the ongoing decline in TB incidence. Key TB control measures include: surveillance and case detection, treatment of TB and latent TB infection, contact tracing, and BCG vaccination.
• Ireland is one of only two Western European countries that has a policy of universal neonatal vaccination despite not being considered a country with a high incidence of TB using the World Health Organisation definition (greater than or equal to 40 cases per 100,000 population). The other country is Portugal.
• Selective vaccination involves vaccinating only the population at higher risk of developing TB. The population at higher risk in Ireland comprises children born to parents from a country with a high incidence of TB and children from the Traveller community in Ireland. These two groups constitute approximately 13.4% of births in Ireland annually. Infants identified as being at higher risk were estimated to have a risk of contracting TB three times higher than that of the general population.
• A change to selective vaccination should be supported by a public awareness campaign that clearly states the rationale for change and ensures that families at higher risk understand the need to seek vaccination and to maintain a high uptake in infants at higher risk. The process of seeking relevant information must be carried out in a way that is non-discriminatory and consistent with the privacy of the infant and the family.
• The extent to which different TB control measures have been implemented in Ireland is in the context of a universal neonatal BCG vaccination programme. A change to one element of TB control would have consequences for the adequacy of the overall approach to TB control. To avoid additional cases of TB, a reduction in protection due to a change in the BCG vaccination policy will have to be balanced by enhancing other aspects of TB control.
• The majority of infants vaccinated incur minor side effects while one in 1,200 infants will incur side effects that require medical follow up.
• A move from universal to selective vaccination would greatly reduce the number of vaccinated infants from approximately 61,000 to 8,000 per annum. It would also significantly reduce the number of children experiencing adverse effects. 
• A policy of selective vaccination would reduce the cost of vaccination by over €1 million. Switching from universal to selective vaccination would lead to lower total vaccine and administration costs, however, as TB control measures must be enhanced in tandem with this change, any budget savings are unlikely to be realised.
• The Health Information and Quality Authority held a six-week public consultation on the draft report from 9 September to 21 October 2015 to provide an opportunity for all potential interested parties and members of the public to give comment and feedback prior to the report being finalised.