Health Canada approves CERVARIX(TM), new GSK cervical cancer vaccine

CNW Group

February 9, 2010

Shown to provide the longest protection against cervical cancer

MISSISSAUGA, ON, Feb. 9 /CNW/ – Health Canada has approved CERVARIX(TM) (Human papillomavirus vaccine (Types 16 and 18) Recombinant, AS04 adjuvanted). CERVARIX(TM) is a vaccine intended to protect females against cervical cancer (cancer of the lower part of the uterus or womb) and abnormal and precancerous cervical lesions (changes in cells of the cervix that have a risk of turning into cancer). It is indicated for girls and women between the ages of 10 and 25.

“In Canada, more than one woman dies every day from cervical cancer, a disease that is largely preventable,” says Dr. Barbara Romanowski, Clinical Professor of Medicine, Division of Infectious Diseases at the University of Alberta. “Together with regular Pap tests, CERVARIX(TM) reduces the risk of cervical cancer caused by HPV types 16 and 18, by 98 per cent.”

CERVARIX(TM) has the longest duration of protection reported for any licensed cervical cancer vaccine(2). It is the only vaccine that has demonstrated that virtually all women tested still have protective antibodies against both HPV 16 and 18 up to 6.4 years.(3)

CERVARIX(TM) contains a unique adjuvant system, AS04, which has been added to the vaccine to improve the immune response by providing stronger and longer protection as compared with a traditional adjuvant.(4) Duration of protection is particularly important as almost all women are at risk of HPV infection and cervical cancer throughout their lives.

Kathy Smith, a 41 year old mother and cervical cancer survivor, encourages women across the country to get vaccinated. “Cervical cancer can be fatal,” she said. “I was fortunate enough to have won my battle, but not everyone does. We should do everything we can to protect ourselves and our loved ones against this disease. The first thing we can and should do is get vaccinated – it just makes sense.”

CERVARIX(TM) has shown protection beyond HPV 16 and HPV 18. GSK’s Phase III clinical trial, which included over 18,000 women, evaluated the efficacy of HPV types 16 and 18 as well as other cancer causing HPV types. In this trial several subsets of women were analyzed. In one analysis CERVARIX(TM) demonstrated protection against HPV type 45 in addition to types 16 and 18. In another, CERVARIX(TM) demonstrated protection against HPV type 31 in addition to types 16 and 18.(5) HPV types 45 and 31 are the third and fourth leading causes of cervical cancer.(6)

“When it comes to preventing cervical cancer, woman have to be very diligent,” said Dr. Dion Neame, Medical Advisor Vaccines, GlaxoSmithKline Inc. “Cervical cancer vaccination and regular Pap screening is the best way to achieve the ultimate goal – to provide women with the best possible protection against cervical cancer.”

CERVARIX(TM) is effective against CIN1 (cervical lesions) caused by HPV-16 and 18.(7) These lesions contribute to approximately 325,000 abnormal Paps every year in Canada which may require surgical intervention.

CERVARIX(TM) is now approved in over 100 countries around the world. To date ten million doses have been distributed globally.

CERVARIX(TM) is generally well tolerated. The most common local adverse reactions and general adverse events in (greater than or equal to)20% of subjects were pain, redness, and swelling at the injection site, fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.

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Educate before you vaccinate Рlook to your sisters to the south before you move ahead with this vaccine.  My understanding is the adverse reactions from Cervarix as reported to VAERS are even worse than Gardasil.

Even crazier is that they are giving the same vaccine to girls ages 10 to 25 – do you realize how many changes the body goes through in that age group?¬† And the menstrual cycle and hormones is a determining factor in how well this age group will tolerate the vaccination. This is a dangerous vaccine – for a virus that typically passes through a woman’s body in 2 years.

L.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.