Merck Responds to Questions about Adverse Events Reported following Vaccination with GARDASIL®
WHITEHOUSE STATION, N.J.- Merck today issued the following statement to address questions about adverse events reported in people who had received GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant].
Merck has analyzed the adverse events reported for GARDASIL relating to the recent reports of death and paralysis, and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. These types of events are events that could also be seen in the general population, even in the absence of vaccination. An adverse experience report describes an event that occurred after vaccination and does not necessarily mean that the vaccine caused or contributed to the event. The vast majority of adverse events that have been reported to Merck are non-serious and the most common include dizziness and syncope (fainting).
“Merck is proud of the public health benefit that GARDASIL can provide in helping to prevent cervical cancer and other HPV diseases caused by HPV types 6, 11, 16 and 18 throughout the world and we remain confident in the safety profile of GARDASIL,” said Richard M. Haupt, executive director, Clinical Research, Merck Research Laboratories. “Merck encourages health care providers and consumers to report any adverse experience associated with GARDASIL to the Company and to the U.S. Vaccine Adverse Event Reporting System so that the Company can continue to thoroughly monitor the safety of this important vaccine.”
Merck 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. For vaccines, Merck also participates in the U.S. Food and Drug Administration and Centers for Disease Control and Prevention adverse event reporting system that collects data on any adverse event following vaccination, whether coincidental or potentially caused by a vaccine.
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. As of March 31, Merck has distributed more than 26 million doses of GARDASIL worldwide, nearly 16 million of them in the U.S., since approval in June 2006.
In 2006, GARDASIL became the only approved vaccine to prevent cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18 in girls and women 9 through 26 years of age. GARDASIL (sold in some countries as SILGARD®) has been approved in 103 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.
Additional important information aboutGARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care. GARDASIL is not recommended for use in pregnant women.
Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts, cervical cancer, CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.
Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper anterior thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDAS
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