Adverse drug events
European Medicines Agency launches safety review of HPV vaccines
Source: Phanie / Alamy
A safety review of human papillomavirus (HPV) vaccines, which protect young women against cervical cancer and other conditions, has been launched by the European Medicines Agency (EMA).
The review will look at rare reports of complex regional pain syndrome (CRPS) or postural orthostatic tachycardia syndrome (POTS) associated with the vaccines to try to determine whether there is a causal link. The review is not being conducted to question whether the benefits of the vaccines outweigh their risks.
Both conditions can occur in non-vaccinated individuals and the EMA wants to discover whether the number of reports of CRPS and POTS among women who receive the vaccines matches the number that would be expected among the general population.
HPV vaccination was introduced into the UK’s national childhood vaccination programme in 2008. It is offered to all 12–13 year olds in England, Wales and Northern Ireland and to all 11–13 year olds in Scotland.
HPV vaccines licensed in Europe include Cervarix, Gardasil and Gardasil 9. Gardasil is approved for use in males and females for preventing precancerous growths and cancer in the cervix and anus, and genital warts. It protects against four types of HPV (6, 11, 16 and 18); Gardasil 9 offers protection against nine virus types (6, 11, 16, 18, 31, 33, 45, 52 and 58); Cervarix is used in women and girls to protect against precancerous growths and cancer in the cervix and genital area and targets HPV types 16 and 18.
Based on its review, the EMA’s pharmacovigilance risk assessment committee will decide whether to recommend any changes to the vaccines’ product information.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068967
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