CERVICAL CANCER VACCINE APPROVED: 

On 6/8/2006, the FDA approved Gardasil, a vaccine developed to prevent cervical cancer and genital warts. 

“FDA approval of the HPV vaccine, the first vaccine targeted specifically preventing cancer, is one of the most important advances in women’s health in recent years,” stated the American Cancer Society in a news release.

The vaccine protects against infection from four strains of the human papilloma virus (HPV).  Two of these strains, HPV-16 and HPV-18, account for about 70% of cervical cancers.  The other two strains covered by the vaccine, HPV-6 and HPV-11, account for about 90% of genital warts.

The HPV vaccine is approved for 9-26 year old girls and women. The age group designations represent the demographics of the 20,000 participants in clinical trials, as well as a “market target.”  We personally feel that it may be appropriate to “bend the rules” on age limits, especially at the older end (for example, a sexually active unmarried 30 year old might be an appropriate candidate.}

Since both men and women get genital warts and cancers associated with HPV ( for example, in men and women, cancers of the skin around the rectum, and penile cancer, which is quite rare are both caused by HPV), clinical trials are underway in boys and men.

EFFECTIVE AND SAFE: The vaccine was extremely effective in clinical trials.  It appears to be 100% effective in protecting against the HPV-16 and HPV-18 strains. It also seems extremely safe.  One reason is that the vaccine isn’t a live virus, but a virus-like particle.

I have already recommended that my daughters, ages 22 and 20 get the vaccine.  As a parent,  safety is my primary concern.  I am convinced of the safety and efficacy of this vaccine.

It is not clear whether or not the vaccine will give lifelong immunity.  In tests so far, the vaccine remains protective for four years and counting.

HOW IT IS GIVEN: To be effective, Gardasil must be given in three doses over six months.  The second dose is given 2 months after the first dose, and the third dose is given six months after the first dose.  

DOES INSURANCE COVER THIS VACCINE? HOW MUCH DOES IT COST?

At this moment, some insurances are covering the vaccine. Please call your insurance first and see if they are covering it.  It is expensive: about $200 each for three doses.

Until there is more universal coverage, we will have you sign a form stating that if insurance does not cover, you will be responsible for the cost. 

Also, for those of you who have kids less than 18 years old, the Boulder County Health Department will be administering Gardasil for $15 sometime late this year.  The price is subsidized for children in our community.  (for more information, call the Vaccine  Program 303-413-7500).

PAP SCREENING STILL NEEDED:  Despite it’s potency, Gardasil won’t prevent every cervical cancer or every HPV infection.  There are some 100 HPV strains out there.   Those covered by the vaccine are the worst offenders, but not the only ones.

Gardasil does not prevent disease in people already infected with the virus.  Perhaps as many as 80% of adults have been exposed to at least one strain of the virus.  For reasons not fully understood, only a small percentage of people with HPV get HPV associated diseases.

Even after getting the vaccine Pap screening will still be very important.  Some vaccinated women will still have  abnormal pap tests. It doesn’t mean the vaccine is not working.  A lot of abnormal Paps  are caused by HPVs  that are not in the vaccine.

THE ROLE OF PARENTS:  This vaccine is probably best administered to girls 11-13 years old. 

As parents, it is important to realize that giving our children the HPV vaccine is not likely to be seen as “permission to have sex.”  It is, however, an opportunity to address such issues. 

Any of you who have had a daughter suffer the anguish of having HPV related disease, with attendant procedures, treatment and then intensive monitoring for several years afterwards, will surely appreciate the value of the vaccine. top