Merck receives Health Canada approval for GARDASIL to treat HPV in women upto age 45

Today, Merck announced that Health Canada has extended the indication of GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine] in women up to the age of 45. Merck's HPV vaccine is now approved for girls and women nine through 45 years of age for the prevention of cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by the Human Papillomavirus (HPV) types 6, 11, 16, 18. Previously, GARDASIL^® was approved in girls and women nine through 26.

"The decision to be vaccinated against HPV-related diseases as an adult should be taken by each individual woman in consultation with her healthcare professional," said Dr. Vivien Brown, a family physician on staff at Mount Sinai Hospital, the University Health Network and North York General Hospital. "The HPV quadrivalent vaccine is not only for young people, both girls and boys, who have not yet been exposed to HPV, it's also effective in older women."

"Whatever the reason, there's a tendency for women to remain at risk of acquiring new HPV infections as they get older. Whether they are changing their social status or not, women should talk to their doctors about the HPV protection provided by the quadrivalent vaccine," said Dr. Alex Ferenczy, Professor of Pathology and Obstetrics & Gynecology at McGill University. "Evidence based medicine now suggests that physicians may propose the HPV quadrivalent vaccine to female patients up to age 45, on an individual basis."

GARDASIL^® was also approved in February 2010 for boys and men nine through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

Efficacy in women up to age 45
GARDASIL^® was evaluated in a placebo-controlled, double-blind, randomized efficacy study (FUTURE III) conducted in 3,817 women aged 24 to 45 years. The primary analysis was conducted in the per protocol efficacy (PPE) population which consisted of individuals who received all three vaccinations within one year of enrolment, did not have any major deviations from the study protocol, and who were naïve to HPV types 6, 11, 16 and 18 when they started the study and remained free of infection to these four HPV types through one month after receiving their last vaccine dose.

The efficacy of GARDASIL^® against the combined incidence of HPV 6-, 11-, 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade and AIS-the immediate precursors to cervical cancer and cervical adenocarcinoma-and cervical cancers was 88.7% (95% CI:  78.1, 94.8).

The most common systemic adverse reaction observed was headache.  Other 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, injection-site pain, swelling, redness or itching of the skin and bruising.

At high risk up to age 45
Women are at high risk for diseases caused by HPV types 6, 11, 16 and 18 up to the age of 45. The lifetime risk for acquiring genital warts-highest for both men and women between the ages of 15 and 34-has been estimated to exceed 10%.

In a Canadian study published in 2009 in the journal, Sexually Transmitted Diseases, more than half (56 per cent) of individuals in a new sexual relationship were infected by HPV. Each year in Canada HPV infections lead to approximately 350,000 abnormal Pap smear results, 41,450 new cases of genital warts, 1,350 cervical cancer diagnoses and 400 cervical cancer deaths. After breast cancer, cervical cancer is the most common cancer in Canadian women between the ages of 20 and 44.