Human Papillomavirus Vaccines: The European Medicines Agency Safety Committee Concludes That Evidence Does Not Support That HPV Vaccines Cause CRPS or POTS

LYON, France, November 5, 2015 /PRNewswire/ --

The European Medicine Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concludes that there is no reason to change the way the vaccines are used or amend the current product information.

Sanofi Pasteur MSD welcomes the European Medicine Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommendation to the Committee for Medicinal Products for Human Use (CHMP). PRAC concluded: "the available evidence does not support that CRPS* and POTS** are caused by HPV vaccines. Reports of CRPS and POTS after HPV vaccination are consistent with what would be expected in this age group. Therefore there is no reason to change the way the vaccines are used or amend the current product information".

The PRAC's recommendation is a key step in the EMA's formal regulatory and scientific assessment of the available safety information related to CRPS and POTS, including requested data and information provided by Sanofi Pasteur MSD in full transparency. Nothing is more important to Sanofi Pasteur MSD than the safety of our vaccines and we are confident in the safety profile of GARDASIL and GARDASIL 9.

Since being launched nearly 10 years ago, 195 million doses of GARDASIL have been distributed worldwide and the vaccine is now licensed in 129 countries. Data from real-world experience in a number of countries, including Australia, Sweden and Denmark, have shown that the use of GARDASIL has resulted in a significant reduction in precancerous cervical lesions and genital warts.

"Preventing cervical cancer is a public health priority in many countries as part of cancer prevention programmes. The value of HPV vaccination has been demonstrated through several studies showing significant reductions in the precancerous lesions that lead to cervical cancer," said Steve Lockhart, Vice President Development at Sanofi Pasteur MSD, "this robust, independent scientific review on the safety of the HPV vaccines reaffirms the safety and benefit profile and provides continued reassurance on the role of HPV vaccination in meeting important public health goals," he concluded.

GARDASIL is indicated to prevent 70 percent of cervical cancer and certain other cancers caused by HPV in females and males. With the recent approval of GARDASIL 9 in several countries, the medical and public health community now has the potential to help prevent 90 percent of cervical cancers caused by HPV.

The PRAC's recommendation will now be reviewed by the CHMP in the comings days. The procedure ends once the European Commission (EC) issues a final decision.

About GARDASIL^® 9 

GARDASIL^® 9, manufactured by Merck, is the first and only nonavalent HPV vaccine helping to protect females and males against genital diseases and cancers caused by 9 human papillomavirus types (6, 11, 16, 18, 31, 33, 45, 52, 58) causing approximately 90% of cervical cancer cases and approximately 80% of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide. These seven HPV types also cause 85-90% of HPV-related vulvar cancers, 80-85% of HPV-related vaginal cancers, and 90-95% of HPV-related anal cancers. HPV types 6 and 11 cause approximately 90% of genital warts cases.

About GARDASIL^® 

Gardasil®, manufactured by Merck, is the only quadrivalent HPV vaccine helping to protect people from genital diseases and cancers caused by the human papillomavirus types 6, 11, 16 and 18: cervical cancer, anal cancer, precancerous lesions of the cervix (CIN2/3), precancerous lesions of the anus (AIN 2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts (condyloma acuminata).

Data published since Gardasil^® came on the market have confirmed the positive impact of this vaccine on the prevention of genital diseases caused by human papillomavirus types 6, 11, 16 and 18.

Launched nearly 10 years ago in 2006, Gardasil is Western Europe's leading HPV vaccine with over 33 million doses distributed and approximately 195 million doses distributed worldwide to date.

About Sanofi Pasteur MSD http://www.spmsd.com

Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the distribution of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck's research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.

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* CRPS stands for "complex regional pain syndrome", a chronic pain condition with symptoms most often affecting the limbs.

**POTS stands for "postural orthostatic tachycardia syndrome", 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.