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.
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
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.
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.