The Danish health authorities Sundhedsstyrelsen has asked the European Medicines Agency (EMA) to re-evaluate the risk profile of the HPV vaccine’s side effects.
The news comes in the wake of numerous reports from girls and young women across the nation complaining that the vaccine has led to symptoms including dizziness and irregular heartbeat.
“Sundhedsstyrelsen has asked for a European evaluation because we have received new reports of alleged side effects of the HVP vaccine,” said Henrik G. Jensen, a spokesperson from Sundhedsstyrelsen.
“It is a concerning development among the many girls and their families and via the EU we must look into the possibility that there is a link between the symptoms and the vaccine.”
Active girls more at risk
According to a recent documentary by TV2, symptoms are particularly prevalent in girls active in sports. A survey from Frederiksberg Hospital showed that 75 percent of the girls showing symptoms had been active at a high level in sports, while half had been active at an elite level.
The HPV vaccine, which was developed to prevent cases of cervical cancer, has been part of the national Danish vaccination program since 2009 and is offered for free to all girls from the age of 12.
Out of the about 500,000 girls and young women who have been vaccinated, slightly over 1,000 have experienced possible side effects – 283 of which were considered serious.
“The review of HPV vaccines has been initiated by the European Commission at the request of Denmark, under Article 20 of Regulation (EC) No 726/2004,” EMA confirmed. “The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
“The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt a final opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.”