EMA's new assessment of the HPV vaccine: The benefits outweigh the risks

17 April 2015

A causal relationship between the dizziness and fatigue syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Gardasil can neither be confirmed nor denied. The EU's group of pharmacovigilance experts have made a new assessment of the vaccine and still consider it to be safe.

The new assessment from EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which is composed of top-level scientific experts, is interesting for Denmark, because the Danish Health and Medicines Authority has reported several cases of POTS as a possible adverse reaction to Gardasil. Thus, the Danish reports form part of EMA’s safety assessment.

POTS is a relatively new diagnosis, and the symptoms include increase in heart rate and dizziness. The syndrome has been observed in young women, who were vaccinated with Gardasil, and in both men and women, who were not vaccinated with Gardasil.

In Denmark, it is primarily the Syncope Centre at Frederiksberg Hospital that diagnoses POTS by making special tilt table tests. During the past years, the doctors at the Syncope Centre have reported several cases of POTS as a suspected adverse reaction to the Gardasil HPV vaccine to the Danish Health and Medicines Authority.

A reported suspected adverse reaction does not necessarily mean that there is a relationship between the vaccine and the symptoms experienced as adverse reactions to the vaccine. Everyone can report adverse reactions on our website, and everything reported as adverse reactions appear from our reports of suspected adverse reactions.

We find it important to investigate whether POTS may be a rare adverse reaction to Gardasil or whether there is a coincidence in time between the vaccine and the syndrome in the specific cases. In 2013, we asked Frederiksberg Hospital to make a report describing the Danish incidents. This report was sent to EMA where PRAC assessed it together with the Danish adverse reaction reports; the committee found that the relationship between POTS and Gardasil can neither be confirmed nor denied at present.

This conclusion is interesting for Denmark, because of the debate about the possible link between Gardasil and POTS in the established media as well as social media in the past few years. The view that the vaccination programme should be put on hold until the relationship can be confirmed or denied is often put forward.

However, it is important to underline that even if POTS had been classified as a possible adverse reaction to Gardasil, it is still our view that EMA would not withdraw the vaccine. Nor would the vaccine be removed from the Danish childhood vaccination programme, because the prevention of many hundred cases of cancer every year outweighs the risks of the reported suspected adverse reactions (see the factbox below). POTS would, however, appear from the package leaflet as a possible, but rare adverse reaction to the vaccine.

We still recommend the HPV vaccine just like WHO, the US Food and Drug Administration (FDA) and EMA, because the benefits of preventing cervical cancer, which is a fatal disease, still outweigh the risk of having adverse reactions to the vaccine.

Facts

  • As at 30 September 2014, a total of 33 cases of POTS as a possible adverse reaction to Gardasil had been reported in Denmark (in the period from 2006 to 2014). However, it has not been possible to document a relationship between the vaccine and POTS.
  • At present, more than 480,000 Danish women have been vaccinated with Gardasil.
  • Globally, a total of 66 cases of POTS had been reported as at 30 September 2014. Around 55 million people have been vaccinated worldwide.
  • About 370 Danish women are diagnosed with cervical cancer every year.
  • About 100 Danish women die from cervical cancer every year.
  • Approximately 6,000 people have surgery for early stages of cervical cancer every year.
  • More than 8,000 people live with a cervical cancer diagnosis.
  • In Europe, more than 33 million doses have been used and around 11 million people have been vaccinated.

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