- The European Medicines Agency (EMA) maintains that the benefits of vaccination against HPV outweigh the risks, but that inquiry into side effects is warranted.
- The overriding concern is a possible link between vaccinations against HPV and two conditions--complex regional pain symdrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).
- While the investigation is underway the recommendations surrounding vaccination against HPV in the various European Union member states will not change.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will be undertaking a full review of the data evaluating the connection between vaccination against HPV and the conditions CRPS and POTS. The HPV vaccines that are available in the E.U. include Sanofi Pasteur MSD's Gardasil/Silgard and Gardasil 9, as well as GlaxoSmithKline's Cervarix.
The HPV vaccine has been given to roughly 72 million people worldwide, with the goal of protecting them from the ravages of certain human papillomavirus (HPV) strains, which can lead to cervical cancer, genital warts and other cancers.
However, there has been backlash against the vaccine for some time, especially in the US, where only one-third of teenagers have been vaccinated despite the fact that the Centers for Disease Control and Prevention (CDC) recommends that all children be vaccinated at ages 11 or 12. One reason for the relatively low level of compliance with the CDC recommendation is a widespread concern about safety.
Although rates of vaccination are higher in many of the E.U. member states, there is also concern about safety---and now there is enough anecdotal evidence to suggest that HPV vaccination may be linked to CRPS and POTS. More data is needed, but the possibility of a large-scale policy change is definitely not out of the question.