EU watchdog will review cervical cancer vaccines
Published 16/07/2015 | 02:30
The European medicines watchdog is examining the safety profile of the vaccine which protects against cervical cancer, following rare reports of girls who received it suffering symptoms such as pains in their limbs and an abnormal rise in their heart rate.
Authorities here have received three reports of these symptoms, according to the Health Products Regulatory Authority (HPRA), which regulates the safety of medicines.
Around 85pc of secondary schoolgirls who are offered the Gardasil HPV vaccine agree to the jab. However, Fianna Fáil spokesman on Dublin, Senator Darragh O'Brien, said its safety should be reviewed after he was told of severe side effects.
The HPRA said yesterday that these vaccines have been used in 72 million people world-wide to prevent cervical cancer and other forms of cancer caused by HPV.
A spokeswoman said the European Medicines Agency review "does not question that the benefit of HPV vaccines outweigh their risks. While the review is ongoing there is no change in recommendations for the use of the vaccine".
She said the EU review will look for more information on rare reports of complex regional pain syndrome - a chronic pain condition affecting the limbs - and postural orthostatic tachycardia syndrome, which is an abnormal increase in heart rate, with symptoms such as dizziness, fainting, chest pains and weakness.
Health Minister Leo Varadkar, in response to Senator O'Brien, said the 861 reports of suspected adverse reactions to the vaccine here since 2006 have been symptoms which would "not be unexpected".
The HPRA said the severe conditions in young women have been looked at during routine safety monitoring. A causal link between them and the vaccines was not established.
"The HPRA will actively participate in this review and any research which could help clarify the frequency of these conditions following vaccination, or help to identify any causal link," said a spokeswoman.
Over 600,000 doses of Gardasil have been distributed in Ireland, with over 524,000 doses administered within the HSE school vaccination programme up to the end of quarter one 2015, the spokeswoman added.
"To date, the HPRA has received two reports of abnormal heart rate temporally associated with the use of Gardasil and one of chronic pain. It is estimated that more than 55 million girls and women worldwide have been vaccinated and there have been 113 of these reports," the spokeswoman pointed out.