REGRET have managed through Dail questioning to get the actual figures on the adverse affects of the HPV vaccines and the results have been shocking. This is despite the government deriding the REGRET campaign and Minister Harris along with the HSE continuously push a message of total safety for the HPV vaccine, dismissing families of healthy girls who became seriously ill after the vaccination in our calls for an investigation – in a campaign of public derision. We trusted the authorities who told us it was a safe vaccine, and they abandoned us when what happened to our children didn't fit their message.
The Irish Adverse Events reporting system is closed to public view. These latest adverse events reporting statistics from the Health Products Regulatory Authority (HPRA) following the #HPVvaccination – obtained via a parliamentary question – make for shocking reading.
How can the Minister for Health and his HSE continue to label our sick girls "unfounded rumours" in light of these reports of serious injury?
This is the reality they are trying to hide from parents. Bear in mind that evidence shows that vaccine adverse events are grossly under-reported at around 1% of total injuries (Harvard Pilgrim Study):
As of 31st December 2018, the HPRA had received 1,187 case reports of adverse reactions, whereby 60% were classified serious.
There were 5,616 system organ class reactions, which makes 4.7 symptoms reported per case (girl). This means that the girls’ symptoms are presented and reported in clusters.
In 319 case reports the patient was described as not recovered and the outcome of a further 167 cases outcome are recorded as unknown. This means that 486 cases are still left unresolved, but yet the HSE insists that there are NO long term side effects (despite the manufacturer trials never testing for them)!
Minister Harris along with the HSE continuously push a message of total safety for the HPV vaccine, dismissing families of healthy girls who became seriously ill after the vaccination in our calls for an investigation – in a campaign of public derision. We trusted the authorities who told us it was a safe vaccine, and they abandoned us when what happened to our children didn't fit their message.
How can Minister for Health Simon Harris continue to refuse an independent investigation of this large group of unresolved cases, in light of these blatant warning signals, presented by the man himself, when questioned in the Dail?
We demand that our legitimate concerns be taken seriously and that Minister Harris and the HSE stop with their campaign of gaslighting and abusing families in need, and investigate our daughters’ symptoms NOW.
Dail Question and Reply
Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source
801. To ask the Minister for Health the number of suspected adverse reactions to the HPV vaccine reported to the Health Products Regulatory Authority, HPRA, as at 31 December 2018; the number of cases reported; the number of system organ class reactions reported; the percentage of cases categorised as serious; the number of cases unresolved; and the regular intervals the HPRA is required to update its national monitoring webpage. [13524/19]
Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source
From the time of first authorisation of Gardasil in 2006 and up to 31/12/2018, the Health Products Regulatory Authority (HPRA) had received 1,187 reports/cases of suspected adverse reactions and events associated with the use of the HPV vaccines (Gardasil, Cervarix and a few reports for which the brand of vaccine is not known). These reports include information on some 5,616 reactions, as many reports/cases contain information on more than one reaction/event, so as you will note, the number of reactions exceeds the number of reports/cases.
In accordance with EU and global reporting requirements, the words used to describe suspected adverse reactions/events are coded by the HPRA to an internationally agreed standard terminology (MedDRA), which is used to facilitate exchange of information by organisations responsible for medicines monitoring. Within this terminology, reaction terms are grouped into System Organ Classes’ (SOCs) by etiology (e.g. Infections and infestations), manifestation site (e.g. Gastrointestinal disorders) or purpose (e.g. Surgical and medical procedures). The 5,616 reactions referred to above occurred across a broad range of SOCs, most frequently involving the general disorders and administration site conditions, gastrointestinal disorders, nervous system disorders, psychiatric disorders and skin/subcutaneous tissue disorders.
Of the 1,187 reports/cases of suspected adverse reactions and events associated with the use of the HPV vaccines (Gardasil, Cervarix and a few reports for which the brand of vaccine hasn’t been identified), 60% are classified as ‘serious’ as per the regulatory definition of a ‘serious’ adverse reaction, which includes circumstances where patients require intervention (e.g. review by their GP) and/or treatment for their symptoms. From currently available information, in 319 reports/cases, the patients were described as ‘not recovered at time of reporting’ and the outcome in a further 167 reports/cases was recorded as ‘unknown’. It is important to note that the HPRA receives reports/cases from a variety of sources and at the time of submission and/or follow up, information on the outcome of the effects experienced may not be available to reporters.
I am informed by the HPRA that it updates its website in relation to report/case figures for HPV vaccine periodically, approximately bi-annually with the last update covering the period to 31/12/18.
Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average of 890 possible events, an average of 1.3 events per clinician, per month. These data were presented at the 2009 AMIA conference
Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health