Adverse HPV reports 'taken seriously' - manufacturer

The company behind the Gardasil HPV vaccine have assured, while they take reports of any adverse reaction “extremely seriously”, such outcomes do not necessarily prove a causal relationship with the vaccine and encourage further investigation, if required.

The statement from Sanofi Pasteur MSD, the Irish subsidiary of Merek Sharp Dolhme, made the comments, after The Anglo-Celt was made aware of several incidents in the local region where families believe their daughters made have become seriously ill as a result of side-effects of the vaccine.
Among the concerns highlighted are limb paralysis, early onset of MS, ovarian failure, even menopause. At the time of going to print, the HSE had still not responded with figures detailing the uptake rates of the vaccination in counties Cavan and Monaghan over since it was first introduced for young teenage girls back in 2010.
But in a statement to The Anglo-Celt, Sanofi Pasteur MSD say that patient safety is the company’s “highest priority”.
“We encourage people to self-report or report on behalf of others, any changes to their health which may or may not be medically confirmed. These reports are taken extremely seriously and are used to monitor long-term safety, however, they do not necessarily prove a causal relationship with the vaccine, but provide health authorities with a line of enquiry for further investigation, if required.”
The Gardasil HPV vaccine is the result of over 10 years of research and development. The safety of the vaccine has continued to be evaluated in several large post-licence surveillance studies in more than one million people (Vichnin et al, 2015).
HPV vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. To date, more than 213 million doses of Gardasil have been distributed globally, and, by January 2016, in Ireland over 580,000 doses of the vaccine has been administered and over 200,000 girls have been fully vaccinated.
Sanofi Pasteur MSD added: “Through constant worldwide surveillance, the safety of medicinal products, including vaccines, is routinely reviewed as part of an ongoing safety monitoring process. While no vaccine or medicine is completely without risk, leading international health organisations throughout the world continue to recommend routine HPV vaccination.”
However, before the Dáil earlier this month, by way of Parliamentary Questions, Deputies Tony McLoughlin (FG), Marc MacSharry (FF), and Martin Kenny (SF) each submitted individual questions to the Minister for Health Simon Harris for response. The were joined by Independents Michael Fitzmaurice and Clare Daly.
Each highlighted concerns, including if incidence of adverse reactions are under-reported as most doctors will not acknowledge any connection between a vaccine and a subsequent serious medical condition that manifests in the weeks or months afterwards.