Tuesday, 5 February 2019

Ceisteanna (412)

Clare Daly


412. Deputy Clare Daly asked the Minister for Health if he will address a matter (details supplied) regarding the Gardasil vaccine. [5476/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The Health Products Regulatory Authority (HPRA) has advised that the use of aluminium hydroxide and aluminium phosphate as adjuvants in products for specific immunotherapy is established for several decades and the substances are defined in the European Pharmacopoeia. The incorporation of aluminium hydroxyphosphate sulphate into the formulation for Gardasil is aimed at enhancing, accelerating and prolonging the specific immune response towards the vaccine antigens (purified proteins for four types of the human papillomavirus). The content of aluminium in Gardasil is well below the upper limit specified in the European Pharmacopoeia.

Adverse reactions (side effects) known to occur in association with Gardasil are outlined in the authorised product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)). The SmPC is intended for healthcare professionals, and the PL is intended for patients and care-givers. Gardasil is contraindicated in patients with known hypersensitivity to the active ingredients or the excipients listed in the product information. All new and emerging safety data related to Gardasil is assessed to continuously monitor its safety, and routine ongoing pharmacovigilance activities are in place to review any new safety signals identified, published literature, or data from any other source of information. In addition, cumulative safety data are assessed at regular intervals to support evaluation of the overall benefit-risk balance of the vaccines. Where necessary and appropriate, the outcome of these assessments results in updates to the product information (SmPC and PL).