Written answers

Thursday, 8 March 2018

Department of Health

Health Products Regulatory Authority

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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393. To ask the Minister for Health the function of polysorbate 80 also known as Tween 80 and polyoxyethylene-sorbitan-20 mono-oleate in the Gardasil HPV Vaccine; the consideration that has been given by his Department that this has contributed towards increased permeability of the blood-brain barrier facilitating the passage of HPV-16-L 1 into the brain tissue; and if he will make a statement on the matter. [11688/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The information that the Deputy seeks with regard to polysorbate 80 is not readily available. Therefore, I have asked the Health Products Regulatory Authority (HPRA) to investigate the matter and reply directly to the Deputy.

It is important to reiterate that the HPRA and the European Medicines Agency continually monitor adverse events to vaccination. HPV is one of the most closely studied and monitored medicinal products. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. There are usually mild and temporary reactions to any kind of vaccination.

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