UPDATED: Merck Comments on Questions about Adverse Events Reported Following Vaccination with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

Nothing is more important to Merck than the safety of our medicines and vaccines. We are confident in the safety profile of GARDASIL.    

While no vaccine or medicine is completely without risk, leading health organizations throughout the world including the US Centers for Disease Control and Prevention (CDC) and the European Medicines Agency (EMEA) have reviewed all of the safety information available to them about GARDASIL and continue to recommend its use. 

For vaccines, Merck participates in the US Food and Drug Administration (FDA), and CDC adverse event reporting system that collects data on any adverse event following vaccination, whether coincidental or potentially caused by a vaccine. Merck also continues to evaluate all safety data in the context of its own post-marketing adverse experience database as well as its ongoing clinical trial database and provides post-marketing reports to regulatory authorities worldwide. 

Human papillomavirus (HPV) diseases are a significant global health burden and Merck is proud to provide the world's first HPV cancer vaccine, a vaccine that can help prevent cervical, vulvar and vaginal cancers and genital warts caused by HPV types 6, 11, 16 and 18.  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. 

The labeling for GARDASIL reflects the extensive data available from our clinical trials of more than 25,000 people and Merck updates its product labels with new safety information as appropriate. 

GARDASIL is approved 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.  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 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% 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 3 separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh over a 6-month period with the first dose at an elected date, the second dose 2 months after the first dose, and the third dose 6 months after the first dose.

Please See Accompanying Prescribing Information and Patient Product Information for GARDASIL

About Merck
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.

Forward-Looking Statement
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.

GARDASIL® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., USA.

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