HIQA Commences Public Consultation on Proposed Changes to BCG Vaccination Programme

Date of publication:

The Health Information and Quality Authority (HIQA) is today commencing a public consultation on proposed changes to the BCG vaccination programme in Ireland. At the request of the Department of Health, HIQA has evaluated changes to the national infant BCG vaccination programme proposed by the National Immunisation and National TB Advisory Committees.

The Health technology assessment of a selective BCG vaccination programme: Draft for public consultation evaluates the clinical- and cost-effectiveness of a proposed change to the Irish BCG programme, as well as organisational and ethical issues. Currently, Ireland is one of only two Western European countries with a policy of universal vaccination against tuberculosis (TB).

HIQA’s Director of Health Technology Assessments, Dr Máirín Ryan said: “The six-week public consultation starts a discussion on the future of Ireland’s BCG vaccination programme. It allows the public to review the Authority’s advice and give their feedback on a potential change to the BCG vaccination programme.”

BCG vaccination is one of a number of TB-control measures in Ireland. TB control focuses on protection, prevention and treatment. In the context of a falling incidence of TB, a shift in emphasis from protection by vaccination to prevention may be appropriate.

In line with global trends, TB incidence in Ireland has been in decline over the past 25 years. The assessment found that Ireland meets the World Health Organization’s (WHO’s) criteria for discontinuing universal vaccination. However, unlike other European countries with a low incidence, Ireland has continued a policy of universal vaccination.

Dr Ryan continued: “In the context of a fall in TB incidence and diminished risk of acquiring TB, there has been a shift in the balance between the benefits and risks of offering vaccination to all infants. Falling TB incidence has decreased the potential benefit of BCG vaccination for the majority of children. Selective vaccination will continue to protect those at higher risk while avoiding unnecessary side effects in those with a limited capacity to benefit from vaccination. The majority of infants vaccinated incur minor side effects while one in 1,200 infants will incur side effects that require medical follow up.”

“Neither vaccination programme is cost-effective, but a selective vaccination strategy would target resources to those who would benefit most. Given the continued decline in TB incidence, selective vaccination offers a better balance than universal vaccination in terms of benefits and harms. The TB-control programme should be optimised prior to any change in the vaccination programme.”

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.

Dr Ryan concluded: “Any decision to change the BCG vaccination programme will require that the public are informed and educated on such a decision. This public consultation starts the discussion and invites feedback from all interested parties.”

The public consultation will last until 21st October, following which the Authority will publish the findings of the assessment and advise the Minister for Health, Leo Varadkar.

Submissions for the public consultation can be made by completing the feedback form (pdf version, docx version).


Further Information: 

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

Notes to the Editor: 

  • BCG stands for Bacillus Calmette-Guérin. The BCG vaccine SSI was authorised for use in Ireland by the Irish Medicines Board in 2001, and has been used in the vaccination programme from July 2002. This vaccine is based on the BCG Danish strain 1331. In the 12 months after its introduction, the vaccine was associated with 41 suspected adverse reactions, all of which involved local reactions.
  • Tuberculosis (TB) remains a global health challenge. An estimated 9 million people developed TB in 2013 and there were 1.5 million deaths from the disease in 2013.
  • Ireland is one of only two Western European countries that have a policy of universal neonatal vaccination despite not being considered a high TB-incidence country using the WHO definition (greater than or equal to 40 cases per 100,000 population). The other country is Portugal.
  • 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.
  • Almost all BCG vaccinations result in mild reactions (including mild ulcers at the injection site and scarring). The rate of adverse reactions to BCG in Ireland requiring medical or surgical follow-up is approximately one in 1,169 vaccinations. Severe reactions include lymphadenitis and abscess formation, and may require medical intervention.
  • Selective vaccination involves vaccinating only the high-risk population for TB. The high-risk population in Ireland comprises children born to parents from a high TB-incidence country and Irish Traveller children. These two groups constitute approximately 13.4% of births in Ireland annually. High-risk infants were estimated to have a risk of contracting TB three times higher than that of the general population.