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Regulatory News | 05 November 2015 | By Michael Mezher
After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used."
There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions.
Upon initiating its review, EMA stated its goal was to "clarify aspects of [the vaccines'] safety profile," and said the review did not question whether "the benefits of HPV vaccines outweigh their risks."
To conduct the review, PRAC consulted with "leading experts in the field" and "thoroughly reviewed the published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States."
PRAC estimates that approximately 150 per million girls and young women develop CRPS and POTS each year, but "found no evidence that the overall rates of [CRPS and POTS] in vaccinated girls were different from expected rates," even when factoring for underreporting.
The committee also acknowledged that more than 80 million girls and women worldwide have received HPV vaccines and the vaccine "is expected to prevent many cases of cervical cancer … which is responsible for tens of thousands of deaths in Europe each year."
PRAC is recommending there be no changes to how the vaccine is used, and finds no reason to change the product information.
In July, Danish health authorities requested EMA look into the safety of HPV vaccines after adverse event reports claimed the vaccine had caused complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in some patients.
Between 2009, when Denmark implemented a vaccination program and June 2015, Denmark received 1,305 adverse event reports related HPV vaccines. During the same period, health authorities in Denmark reported more than 1.6 million doses of the vaccine were sold.
However, according to Danish authorities, only 47 reports of CRPS (as of 30 September 2014) and 66 reports of POTS (as of 31 December 2014) have been made globally.
Tags: Pharmacovigilance Risk Assessment Committee, PRAC, HPV vaccine, Gardasil, Cervarix, POTS, CRPS