HPV vaccination - no causal relationship with CRPS and POTS.
A re-examination of the safety and efficacy of human papillomavirus vaccines (HPV vaccines) has been completed. After evaluation of the current data by the Pharmacovigilance Risk Assessment Committee (PRAC), no causal association between the HPV vaccines and the occurrence of complex regional pain syndrome (CRPS) or postural orthostatic tachycardia syndrome (POTS) was identified.
Thus, there is no need to change the route of administration of the vaccines or to revise the current product information of the vaccines.
Action at EU level
The European Commission had previously initiated a so-called Article 20 procedure under Regulation (EC) No. 726/2004 at the request of the Danish Medicines Agency to additionally review the safety profile of human papillomavirus vaccines (HPV vaccines). The current analysis made reference to two rarely reported syndromes - complex regional pain syndrome (CRPS) a chronic limb pain disorder, and postural orthostatic tachycardia syndrome (POTS) a syndrome of orthostatic dysregulation characterized by marked increase in heart rate after sitting up or standing, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness. At the conclusion of the trial, it appeared that there was no causal association between HPV vaccines and these two syndromes. Thus, the benefits of HPV vaccination outweigh the known side effects.
To date, approximately 80 million people worldwide have been vaccinated against precancerous tissue lesions in the genital area, as well as cervical cancer and certain other malignancies, with HPV vaccines licensed in the EU. Cervical cancer is the 4th leading cause of cancer death in women worldwide, with 20,000 deaths each year in Europe. Vaccination is expected to prevent many of these cancers in the future.
Situation in Austria
In Austria, the following medicinal products are approved:
- Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed) 20 µg/20 µg injection suspension.
- Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed) 20 µg/20 µg injection suspension, multiple doses
- Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed) 20 µg/20 µg injection suspension in a prefilled syringe
- Gardasil (HPV type 6,11,16,18) injection suspension in prefilled syringe
- Gardasil (HPV type 6,11,16,18) injection suspension in vials
- Gardasil 9 (HPV type 6,11,16,18,31,33,45,52,58) Injection suspension
- Gardasil 9 (HPV type 6,11,16,18,31,33,45,52,58) injection suspension in a prefilled syringe
- Silgard Injection suspension
- Silgard Injection Suspension in a Prefilled Syringe BASG has not received any reports of CRPS and POTS from Austria.
BASG recommendations: the analysis confirmed the positive benefit/risk profile of HPV vaccines. As a result of the completed procedure, there is no reason to change the current vaccination recommendations. More information:
Information on HPV vaccines from the European Medicines Agency (Nov. 20, 2015):
www.ema.europa.eu/ema/index.jsp
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000
E-mail: presse@ages.at
