The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. All HPV vaccines available in the EU are authorised by the European Medicines Agency (EMA).
Gardasil vaccines were first authorised by the European Commission in 2006 to be placed on the market for use across the European Union (EU). To be granted authorisation, the company responsible for marketing Gardasil had to provide evidence that the vaccines met clear and predefined standards of quality, safety and efficacy as set out in legislation, guidance documents and the European Pharmacopoeia. The composition of Gardasil is aimed at enhancing, accelerating and prolonging the specific immune response towards the vaccine antigens. I am informed by the HPRA that further information regarding the authorisation process, steps taken before and after authorisation and the outcome of ongoing monitoring and other regulatory activities for these vaccines can be found on the EMA website.
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 substances or to any of the excipients listed in the product information. All new and emerging safety data related to Gardasil are assessed to continuously monitor its safety and routine ongoing pharmacovigilance activities are in place to review any new safety signals identified in 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. As part of this process, the company responsible for marketing Gardasil was requested to closely monitor events involving autoimmune disorders. In January 2018 the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the cumulative data gathered since authorisation of the product did not show a clear or systematic pattern of association between vaccination with Gardasil and the development of autoimmune disorders.