New Study Reinforces Safety Profile of GARDASIL®, the Cervical Cancer Vaccine
WHITEHOUSE STATION, N.J., Aug. 18, 2009 - Merck is proud to have introduced GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], the world's first cervical cancer vaccine, a vaccine that can also help to prevent vulvar and vaginal cancers and genital warts caused by HPV types 6, 11, 16 and 18. The paper being published in JAMA on Aug. 19 by the Centers for Disease Control and Prevention (CDC) is another important milestone in the medical community's ongoing effort to monitor the safety of vaccines, including GARDASIL.
"We are pleased that the study published by JAMA today further reinforces the safety profile of GARDASIL. We welcome continued study and discussion about the safety of this important vaccine," said Richard M. Haupt, M.D., MPH, pediatrician and head of the clinical program for GARDASIL. "Our children, our parents, our spouses and we, ourselves, are vaccinated with the same vaccines that we distribute to the public every day. Merck knows that our customers make choices about the medicines and vaccines used by their families, too. That is why we remain committed to providing timely and comprehensive information about the safety and efficacy of our products."
Nearly 500,000 women are diagnosed with cervical cancer each year around the world, and 50 years after the advent of pap testing, an average of 30 American women are still diagnosed with cervical cancer each day. HPV types 16 and 18 cause approximately 70 percent of cervical cancer cases.
The VAERS database that was the primary source for the CDC's paper is one of the many mechanisms used to assess the safety of vaccines. Merck also monitors vaccine safety by conducting comprehensive analyses of adverse events reported to Merck, and we share these adverse event analyses with the CDC, the U.S. Food and Drug Administration (FDA) and regulatory and medical authorities around the world to support their efforts. Merck is also conducting a post-marketing surveillance study in girls and women to assess the safety of the vaccine in routine use. CDC and FDA are also conducting studies. These analyses are in addition to the robust safety data generated from clinical trials of more than 25,000 people that were the basis for the approval of GARDASIL in more than 100 countries around the world. We also continue to follow patients in our clinical studies. After carefully reviewing all of the information available to us about reported adverse events including the findings in the JAMA paper, Merck continues to be confident in the safety profile of GARDASIL.
While no vaccine or medicine is completely without risk, leading health organizations throughout the world including the CDC and the European Medicines Agency (EMEA) have reviewed the available safety and efficacy information about GARDASIL and continue to recommend its use.
While it is difficult to determine the exact number of doses administered, since its launch in 2006 more than 50 million doses of GARDASIL have been distributed worldwide as part of the global fight against these HPV diseases.
Merck is committed to the prevention of HPV diseases including cervical, vaginal and vulvar cancers as well as genital warts caused by the HPV types included in GARDASIL. Education is a critical component toward achieving that goal. As such, Merck will continue to provide independent grant support to professional medical associations that develop and distribute their own educational information about HPV and cervical cancer to broad audiences, including underserved communities.
GARDASIL is approved for use in the U.S. in girls and women 9 to 26 years of age for the prevention of cervical, vulvar, and vaginal cancers; precancerous or dysplastic lesions and genital warts caused by HPV Types 6, 11, 16 and 18. GARDASIL (sold in some countries as SILGARD®) has been approved in 112 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.
Important information about GARDASIL
GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).
GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV Types 16 and 18.
Select safety information
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
GARDASIL is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.
Dosage and administration