MERCK Press Release Touting Clinical Efficacy of Gardasil for Mature Women

The product information for Gardasil® has been updated to include the clinical efficacy and safety of the vaccine for women up to 45 years of age.

– The product information of the four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® has been updated to include the clinical efficacy and safety information of the vaccine for women up to 45 years of age.*,1

In a clinical study which included 3,819† women between 24 and 45 years of age, among those who were not infected with the relevant virus type at vaccination‡ and who received all three doses of the vaccine (3,351 women§, Gardasil® prevented 90.5%** of HPV 6-, 11-, 16-, or 18-related persistent infection, cervical lesions (CIN††) of any grade, adenocarcinoma in situ (AIS), cervical cancer, vulvar and vaginal lesions and genital warts.1,2

Gardasil® was generally well tolerated and demonstrated a good safety profile with fever as well as redness, swelling and pain at the injection site as the most commonly reported side effects.1,2

“Vaccination recommendations or campaigns from health authorities will continue to focus on adolescent girls. However, women may remain at risk of HPV infection and developing related diseases during their adult life. Women should be aware of the efficacy and safety of Gardasil® up to 45 years. They should make an informed decision about individual vaccination following discussion with their doctors taking into account their personal and HPV disease histories“, says Professor Xavier Bosch from the Catalan Institute of Oncology in Barcelona, Spain.

All women should continue regular screening for early detection of cervical cancer whether they have been vaccinated or not. Gardasil® is a preventive vaccine and can therefore not treat preexisting infections or disease. The vaccine cannot protect against all HPV types.

Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.