Merck is Pleased the FDA and CDC Re-affirm the Safety Profile of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]
Note to editors: The head of the clinical research program for GARDASIL is available for comment, including broadcast interviews.
WHITEHOUSE STATION, N.J., Aug. 20, 2009 - Merck is pleased that the US Food and Drug Administration (FDA) and US Centers for Disease Control and Prevention (CDC) reaffirmed this morning that, "based on the review of available information by FDA and CDC, GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks."
The FDA's full statement is available here: (Gardasil Vaccine Safety, posted: 8/20/2009).
"We will continue our practice of effectively communicating the safety profile of GARDASIL -- it's a responsibility Merck takes very seriously," said Richard M. Haupt, MD, MPH, head of the GARDASIL clinical program.
"We hope that the many parents who may have been frightened this week by misleading reports understand that Merck people are parents, too. Our own children are vaccinated with GARDASIL. I am a father and a pediatrician who has worked on GARDASIL for six years, and all of my daughters have been vaccinated with GARDASIL.
"Parents should understand the extensive data supporting the safety profile of this vaccine, and we encourage them to look to CDC and FDA, and to the advice of their own physicians, to make an informed choice about something as important as a vaccine to help prevent cervical cancer.
"Nearly 500,000 women are diagnosed with cervical cancer each year around the world. Even 50 years after the advent of pap testing, an average of 30 American women are still diagnosed with cervical cancer each day. Now that there is a vaccine, we have an opportunity to not only impact this disease through early detection but also through a medical intervention."
GARDASIL is for use 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. HPV types 16 and 18 cause approximately 70 percent of cervical cancer cases.
Important information about GARDASIL
GARDASIL does not substitute for routine cervical cancer screening, and women who receive GARDASIL should continue to undergo screening.
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
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.
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
GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh over a six-month period with the first dose at an elected date, the second dose two months after the first dose, and the third dose six months after the first dose.
Please see accompanying Prescribing Information and Patient Product Information for GARDASIL.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.