The European Medicines Agency (EMA), the EU's drugs authority, announced on Monday that it would review the safety of the human papilloma virus (HPV) vaccine.
The decision by the EMA
to "further clarify aspects of [the vaccine's] safety profile" comes in the wake of pressure from the Danish Health and Medicines Authority (Sundhedsstyrelsen), which has been following reports of young Danish girls negatively affected by the vaccine. Health officials in Japan have also raised questions about the vaccine's safety.
The EMA states that more than 72 million women have been vaccinated against the HPV virus to protect them from cervical cancer since 2006.
"Cervical cancer is the fourth most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early. The review does not question that the benefits of HPV vaccines outweigh their risks," the EMA press release stated.
The review is been carrying out by EMA's own side effects committee, PRAC, which according to Swedish newspaper Svenska Dagbladet has had internal disagreements over how to handle mounting suspected evidence of medical risks connected to the vaccines.
Denmark requested the EMA review after doctors at Frederiksberg Hospital noticed that an increasing number of young girls who had been vaccinated with HPV vaccine were subsequently treated for side effects including fainting and irregular heartbeats.
Over 100 Danish girls have thus far applied for financial compensation for their side effects and according to Svenska Dagbladet, three of them have received compensation totaling more than four million kroner ($593,000 or 536,000 euro). As many as 800 Danish girls have reported side effects from the vaccine.
The Danish health minister, Sophie Løhde, called the EMA’s decision “sensible”.
“Both the [European] side effects committee and the Danish Health and Medicines Authority here at home assess that the advantages of the vaccine against cervical cancer are greater than the disadvantages and continue to recommend that young girls get vaccinated,” Løhde said in a press release.
“But it is important for me that we react when there continues to be new reports of side effects and there is also concern among many girls and their families. Wd should take that seriously,” she added.
PRAC's evaluation of the vaccine's safety will be sent on to the Committee for Medicinal Products for Human Use for a final a final opinion, which the European Commission will then adopt for all EU countries.
The review will focus on two possible side effects of the vaccine: complex regional pain syndrome (CRPS), which causes chronic and severe pain in legs or arms, and postural orthostatic tachycardia syndrome (POTS), which can cause an array of symptoms including headache, dizziness, fainting, and fatigue.
"Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected," the EMA stated.
HPV is the most common sexually transmitted infection. Certain HPV strains can cause cancers of the cervix, head, neck and anus.
The HPV vaccine is free to all 12-year-old girls in Denmark and has been included in the national vaccination programme since 2009.