EMA Clarifies HPV Vaccines’ Safety Profile

EMA Clarifies HPV Vaccines’ Safety Profile

The European Medicines Agency (EMA) recently initiated a review focused on HPV vaccines with the purpose of advancing knowledge and clarifing their safety profile. These vaccines have already been used in 72 million people in the world and are intended to prevent several cases of cervical cancer (neck cancer and womb cancer) along with other cancers and conditions that result from HPV infection.

Cervical cancer is one of the most frequent causes of cancer-related death in women worldwide and accounts for tens of thousands of deaths each year despite current screening programs. This recent review does not question that the risks of HPV vaccines outweigh their benefits. Instead, it evaluates available data on 2 conditions: complex regional pain syndrome (CRPS), a chronic pain condition that affects the limbs, and postural orthostatic tachycardia syndrome (POTS), a condition in which the heart rate rises abnormally after standing up or sitting, causing dizziness, fainting, headache, chest pain and weakness.

HPV vaccines are available and commercialized in the European Union under the names Gardasil/Silgard, Gardasil 9, and Cervarix. Gardasil was cleared in September 2006 for females and males to prevent cervical and anal cancer along with genital warts. Its protection includes types 6, 11, 16 and 18 of HPV. Gardasil 9 was approved in June 2015 against HPV type 6, 11, 16, 18, 31, 33, 45, 52 and 58. In contrast, Cervarix can only been used in women to protect from cervical and genital cancers originating from the 16 and 18 HPV strains.

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Cervical cancer, like all cancers, has different treatment modalities and there is often a need for multiple approaches to therapy involving surgery, radiation therapy and/or chemotherapy. The choice of treatment should take into account both efficacy and safety. That is to say that both doctor and patient must discuss the potential side effects of these therapies. A recent study published in the Practical Radiation Oncology journal provides new insights into the side effects of a specific type of radiation therapy used in cervical cancer treatment: Extended-Field Intensity Modulated Radiation Therapy.

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Isaura Santos graduated with a BS in Cell and Molecular Biology from Universidade Nova de Lisboa and a MA in Communication, Culture and Information Technologies from University Institute of Lisbon (ISCTE-IUL). Her professional interests include science communication, public awareness of science and communication of science through entertainment.

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