European Medicines Agency started reviewing HPV vaccines safety

EMA confirmed evidence does not support that HPV vaccines cause CRPS or POTS… but the Nordic Cochrane Center said their report is flawed…

image of hpv-vaccine
Concerned by reports of serious adverse effects in young women receiving human papillomavirus (HPV) vaccines, the European Medicines Agency started a safety review. Three HPV vaccines are currently licensed in Europe: Gardasil/Silgard, Gardasil 9, and Cervarix, all of which are approved in the U.S. as well.

July 2015

The European Medicines Agency (EMA) started a review of HPV vaccines to further clarify aspects of their safety profile.

The review looked at available data with a focus on rare reports of two conditions:

  • complex regional pain syndrome (CRPS)
    a chronic pain condition affecting the limbs,
  • postural orthostatic tachycardia syndrome (POTS)
    a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness.

In its review the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) considered the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee decided whether to recommend any changes to product information to better inform patients and healthcare professionals.

November 2015

EMA concluded this review : HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS.

Summer 2016

An official complaint has been filed by the Nordic Cochrane Center against the European Medicines Agency (EMA) over its handling of safety issues concerning human papillomavirus (HPV) vaccines.

In the complaint, which runs to 19 pages, the Nordic group says that the official EMA report is flawed.

  • Complaint to the European Medicines Agency (EMA) over maladministration at the EM, Nordic Cochrane Centre, 26 May 2016.
  • Complaint Filed Over EMA’s Handling of HPV Vaccine Safety Issues, Medscape Medical News, July 05, 2016.

Did you take the Gardasil Cervarix HPV Vaccine Survey?

Hormones Matter has been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines Gardasil or Cervarix

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Hormones Matter has been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines Gardasil or Cervarix.

At Hormones Matter we have been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines Gardasil or Cervarix. Anecdotal evidence is great, but objective data are better. We must resolve this issue, our daughter’s lives depend upon it.

We need your help to gather the data to understand the real prevalence of side-effects, the range and severity of side-effects and who is most at risk for these complications. Please take this survey and share it with your friends, sisters, colleagues and anyone you know who has been given the HPV vaccine. We will need thousands of women to find the connections. That requires crowdsourcing and sharing amongst women.

The survey is anonymous.

Because of the age of some of the girls given the HPV vaccine and the severity of the adverse events that include death and severe disability, we allow parents, family members and/or friends to take the survey for the affected individual.

Finally, this is a long survey, approximately 30 minutes. We wish it were shorter, but both the depth of the information and the limitations of survey software combine to make this a longer than desired survey. Given that some girls and women are dying or suffering from life long adverse events, we felt it was more important to be thorough than short and incomplete.

We will be creating a second survey, over the coming months, to assess the adverse events in boys and men now being given the vaccine.

Thank you in advance for taking the survey.

Sources and more information