Understanding Gardasil

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If you have preteen or teenaged children, you may have heard about a vaccine called Gardasil®.  It is used in the prevention of certain strains of the human papillomavirus (HPV), which is the leading cause of cervical cancer.  The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the American Cancer Society say that Gardasil® is safe and effective.

There are more than 70 types of HPV that can affect the genital areas, mouth, and throat of males and females.

Genital human papillomavirus (HPV) is the most common sexually transmitted virus in the United States.  More than half of sexually active men and women are infected with HPV at some time in their lives.  In fact, the CDC says that about 79 million Americans are currently infected with the virus, with about 14 million becoming newly infected each year.  That sounds alarming, but most people with HPV never develop symptoms or health problems — 9 out of 10 HPV infections go away by themselves within 2 years.  However, HPV causes cervical cancer, which is the second leading cause of cancer deaths among women worldwide.  Also, HPV can be a factor in cancers of the vulva and vagina in women, the penis in men, and the anus and throat in both men and women; it can also cause genital warts.  In the U.S., about 17,500 women will get cervical cancer each year, and about 4,000 will die from it.  About 9,300 men per year are affected by HPV-caused cancers.

There are more than 70 types of HPV that can affect the genital areas, mouth, and throat of males and females.  The newest version of the HPV vaccine is Gardasil®9, which fights the 9 HPV strains most likely to cause cancer and genital warts.  The original version of the vaccine was approved by the FDA for girls in 2006 and for boys in 2009.  Gardasil®9 was approved in December, 2014.  It is routinely administered at 11 or 12 years of age but may be given beginning at age 9 up through age 26.  The vaccine is given in 3 injections over 6 months; the second injection is 2 months after the first, with the third following 6 months after the initial shot.

There can be some side effects, though severe reactions are extremely rare.  Nine out of ten people who receive the vaccination will experience soreness in the area of the injection, and about a third will experience swelling.  About one in three will get a headache, and about 10% will experience a fever (most are mild).  There may be redness or itching at the injection site, and some people will experience nausea and dizziness.  Many healthcare providers suggest sitting down for up to 15 minutes after the injection to prevent fainting, which happens on occasion with the HPV vaccine.

Vaccination with Gardasil (or the other HPV vaccine called Cervarix) is not a substitute for cervical cancer screening.  The vaccine does not protect against all strains of HPV.  Women should continue to get regular gynecological exams and Pap tests.  HPV vaccines also do not protect against other sexually transmitted diseases nor do they treat existing HPV-related illnesses or infections.

The vaccine has been given to at least 12 million people worldwide, mostly teenage girls.  In clinical trials involving 30,000 people, potential side effects ranging from fever to death occurred at the same rate whether patients were given Gardasil or a saline solution placebo.  This means that the vaccine didn’t produce any noticeable ill effects in the clinical trials, which involved a lot of people.

This leads researchers to conclude that Gardasil is safe.  At least 80 million doses have been administered in the U.S. with no serious problems.  The CDC has found no proof that HPV vaccines cause serious side effects (other than the minor reactions mentioned here earlier).  Research has not shown that HPV vaccines cause fertility problems; in fact, the vaccines help protect women from future fertility problems linked to cervical cancer.  There are no harmful ingredients in HPV vaccines.  They protect against almost all cervical HPV infections and pre-cancers.  (Even though only 9 strains of HPV are addressed by Gardasil, those 9 strains account for up to 90% of all HPV-caused cervical cancer.)  And it’s not just short-term protection.  Studies have shown that the HPV vaccine provides good protection for at least 8 years and that the antibody level is higher after vaccination than after a natural infection.  Experts predict that the vaccine will provide protection in the body for at least 15 years, maybe longer.  Research around the world continues to show substantial reductions in the incidence of HPV infections and genital warts in populations who have received HPV vaccines.

But the vaccines have been in use for only about 10 years.  Any possible long-term risks are not known nor understood.  HPV vaccines are not effective against every strain of HPV; they combat the ones which are most likely to cause cervical and the other related cancers and genital warts, but patients who receive the vaccine are not completely protected against all forms of HPV.  The vaccines only prevent; they don’t treat currently active infections, cancer, or genital warts.

Proponents ask the question:  if you could do something that will protect your child against some types of cancer, wouldn’t you do it?

About 20,000 complaints have been registered with the Vaccine Adverse Events Reporting System (VAERS).  Most of these have been about the minor side effects we talked about earlier, but a few have been more serious — deep vein thrombosis (blood clots) and Guillain Barre Syndrome, a rare nerve disorder that causes severe muscle weakness.  It’s not certain that these were directly related to the vaccine.  The most current negative view about HPV vaccines is not about whether they are safe and effective, it’s about whether or not they’re really necessary.  The argument is that cervical cancer is not very common and is slow-growing, taking years to progress from a normal Pap to true cervical cancer.  In other words, this view is that the HPV vaccine is a blanket fix for a fairly uncommon and slowly-developing disease.

When Rick Perry was governor of Texas, he issued an executive order adding Gardasil to the state’s required vaccination list.  The order was later overturned by the Texas legislature.  Merck, the manufacturer of Gardasil, has lobbied governments to make vaccinations with Gardasil mandatory for school attendance, which has upset some groups who feel that parents should retain the right to make that decision.

The facts about HPV vaccines are pretty convincing.  Studies show dramatic reductions in HPV infections (as much as 75%) and genital warts.  Side effects appear to be minor and temporary, with serious reactions extremely rare.  It seems there are lots of pluses, very few minuses.  Proponents ask the question:  if you could do something that will protect your child against some types of cancer, wouldn’t you do it?  Others feel that an HPV vaccine is not necessary.  What do you think?

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