HPV Vaccine Fear Factor

First, let me say a word about HPV and the Gardasil vaccine itself.  HPV stands for Human Papilloma Virus. Certain strains of HPV can cause cervical cancer while other strains can cause genital warts. The virus is actually quite ubiquitous--it's estimated that up to half of women contract it at some point in their lives.  Most (90%) of these infections clear on their own with no treatment. A small proportion of the time abnormalities develop on the cervix that, if left untreated, can rarely lead to cervical cancer. Signs of an HPV infection of the cervix may show up as an abnormal pap smear. The vaccine prevents two of the most common strains that cause cervical cancer and and the two that most commonly cause genital warts but not all of them.

You've no doubt seen the commercials for Gardisil  (Merck & Co, Inc, Whitehouse Station, New Jersey).  I know my patients request little information from me when I mention the vaccine and often have decided in favor of it before I even begin our discussion. This is the dream of a strong marketing department.  So what's the recent hullabaloo about this vaccine? 

Well, we have a great, albeit imperfect, system for tracking vaccine side effects and harms after it has been licensed for public use.  While the FDA requires several layers of study before a vaccine is approved, more can always be learned once tens of thousands of people have received a vaccine. There have even been occasions in which a vaccine has been pulled from the market due to what was reported through the Vaccine Adverse Event Reporting System  (VAERS).

Designed to capture problems that might not have shown up in the pre-marketing studies,  reports come from doctors, patients, parents, pharmacies, state health agencies and the makers of the vaccines.  Vaccine manufacturers are the only entities required to report. The others are strictly voluntary.

VAERS is not perfect by any stretch. The reports don't always provide enough information and may contain errors. In addition, because patients often receive multiple vaccines at a time, it's hard to draw conclusions about a reaction to just one of them. The reports can't usually confirm whether a vaccine truly caused the reaction and can only speak to an association in time between the reaction and getting the vaccine. As imperfect as it may be, VAERS is an important and valuable resource for monitoring the safety of our vaccines.

Before the Gardasil vaccine was licensed for general use, more than 21,000 women received it. In these studies, the reported rate of problems (like headache, fever, nausea) associated with getting the vaccine was similar to placebo.  Only about 10 people even got a severe injection site reaction.  The Merck marketing team had cause for celebration. At a $360 retail price for the series of three shots, the windfall was poised for landing.

Then along came the August 19^th issue of the Journal of the American Medical Association (JAMA) that tells about what has been learned through VAERS since the release of Gardasil.   Between June 2006 and December 2008, 12,424 reports were made and over 23 million doses of the vaccine were administered.  Most, (68%) in this case, were submitted by the manufacturer. That's more than usual for vaccines. The most frequently reported adverse reactions were fainting, dizziness, nausea, headache and injection site reactions. 

Here's what's getting all the attention: in those more than 12,000 VAERS reports, there were 32 reports of death following receipt of the vaccine.  Only 20 of these could be verified and four of those were of unexplained cause. The others seemed to have an obvious cause separate from the vaccine. While none of us would want our child to be one of those four deaths, it's important to interpret this information with great caution. 

The bottom line of the JAMA article is that the VAERS data shows similar findings to the pre-licensure studies. So despite the media attention, there's really no news here.  

However, an accompanying editorial in the same JAMA issue questions how the vaccine was marketed through funding given by the manufacturers to professional medical associations.  This funding encouraged educational programs promoting the vaccine. While the Advisory Committee on Immunization Practices (ACIP) is the go-to organization for immunization recommendations, professional medical associations can use their clout to influence the behavior of their members (physicians, nurse practitioners, physician assistants, etc.) 

I will say that the recommendation to give the vaccine to girls as young as 9 years was a bit of a shock to me and some of my colleagues.  At this time we don't even know for how long the vaccine will be effective.  It may only be five years so a 9 year old immunized now will be just 14 in five years and (hopefully) not sexually active yet. So the CDC recommends immunizing 11 and 12 year olds.  It was a major financial coupe for the manufacturers to get the FDA recommendation for as low as 9 years old.  Cha-ching!

Since the vaccine is most effective before a woman becomes sexually active, many of the 19-26 year old women stand to gain little benefit. The American Cancer Society also advocates the vaccine for the 11-12 year old girl. This is the age group most likely to benefit and when considering the potential (even remote) for harm, it just doesn't make sense to give it younger and probably not to those who are already sexually active.

Don't get me wrong. I think the vaccine is a good idea for some people--just not everyone.  So choose wisely. And now the studies are coming in for vaccinating boys...