EMA To Review Side Effects of HPV Vaccines

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-14-2015 10:44


The European Medicines Agency (EMA) has started a review of human papillomavirus (HPV) vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide, and their use is expected to prevent many cases of cervical cancer and various other cancers and conditions caused by HPV. The EMA said the review does not question that the benefits of HPV vaccines outweigh their risks.

The review, conducted by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC), will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness).

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.

In its review the PRAC will consider the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the committee will decide whether to recommend any changes to product information to better inform patients and healthcare professionals. While the review is ongoing, there is no change in recommendations for the use of the vaccine.

HPV vaccines are available in the European Union under the names Gardasil/Silgard, Gardasil 9, and Cervarix. Gardasil has been authorized since September 2006, and is approved in both males and females for preventing precancerous growths and cancer in the cervix and anus, and genital warts. It protects against 4 types of HPV (types 6, 11, 16 and 18). Gardasil 9 (approved in June 2015) is used similarly but protects against 9 types of the virus (6, 11, 16, 18, 31, 33, 45, 52 and 58). Cervarix has been approved since September 2007 for use in women and girls to protect against precancerous growths and cancer in the cervix and genital area. It is active against types 16 and 18 of the virus.

Source: European Medicines Agency


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