regulatoryThe 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 (complex regional pain syndrome) and POTS (postural orthostatic tachycardia syndrome) 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% 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% 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.