Wednesday, 8 May 2019

Questions (1120)

Stephen Donnelly


1120. Deputy Stephen Donnelly asked the Minister for Health the reassurance that can be offered to those concerned regarding the Zostavax vaccine for shingles in view of the litigation in the United States of America alleging serious side effects [20126/19]

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Written answers (Question to Health)

Zostavax is authorised for use across the EU since 2007 for the prevention of herpes zoster (shingles) and herpes zoster related post-herpetic neuralgia in individuals 50 years of age or older. It is a live attenuated vaccine and is, therefore, not suitable for certain individuals (including patients who are immunosuppressed).

The Health Products Regulatory Authority (HPRA) has advised that the litigation referred to in the Deputy's question relates to cases in the US involving severe episodes of shingles after receiving the vaccine. As is the case with all medicines (including vaccines), there are a number of potential risks associated with its use. The risks associated with the Zostavax vaccine are clearly outlined in the approved product information accompanying the vaccine.

These documents, developed for both patients and healthcare professionals, include information on the rare but potential risks associated with the vaccine. The product information also highlights the risks for patients who are immunosuppressed or immunodeficient.

The most recent EU periodic assessment of Zostavax, concluded in 2018, reviewed all available global safety information including information from scientific literature, cumulative safety data analysis and epidemiological studies. The assessment concluded that the benefits of the vaccine outweigh any associated risks. The HPRA considers all new data and information in relation to medicinal products and monitors the safety of all authorised medicinal products, including vaccines, on an ongoing basis, in conjunction with its EU partners.