Not so long ago I commented on a study that demonstrated the effectiveness of a vaccine against the human papilloma virus, or HPV, that is now considered responsible for causing almost all cases of cervical cancers here in the United States and throughout the world.

What was exciting about the research report that prompted the blog entry was that the vaccine, tested in other countries in young women, was 100% effective in preventing HPV infection.  In addition, although the duration of the study was short, there was already a discernible decrease in the number of vaccinated women who developed cervical cancer compared to those women who did not.

At that time, it was apparent to most folks that the company that had sponsored the clinical trial and who had developed this particular vaccine was probably going to move quickly to get the vaccine approved by the FDA.

The company, Merck, did in fact submit a new drug application to the FDA in late 2005, and the approval process is moving forward.  Merck has recently announced that the vaccine has been given a priority review status with an anticipated decision by June 8.

Hand in hand with the approval process is another important deliberation, which is review by the Advisory Committee on Immunization Practices (ACIP) that provides guidance as to who should receive the vaccine, and when.  The opinions of this committee are crucial, since their recommendations are key in determining the population to be immunized, as well as how payment for the vaccine will be handled by various federal programs.

Organizations like the American Cancer Society are involved on another level as well, namely educating opinion leaders and the public on the vaccine, its value and effectiveness, as well as addressing some of the issues that will become front and center as this vaccine moves through the approval process.

The potential value of this vaccine is nothing short of incredible, and its impact will be significant.

Cervical cancer, fortunately, has become uncommon in the United States.  There will be about 9710 new cases diagnosed in this country in 2006, and 3700 women will die from this disease.

However, many, many more women every year will be told they have an abnormal pap smear and will have to undergo follow-up, which can vary from repeating the Pap test at a particular time, up to having surgery to remove areas of abnormal (but not cancerous) cells.  There is the possibility with some of the more advanced surgeries that a woman’s ability to carry a pregnancy to term may be adversely affected. 

This is no small matter.   An effective vaccine against the virus that causes cervical cancer has the potential over the next several decades to change the face of gynecology practice as we know it today. The total cost in health care dollars spent in this country annually for the treatment of HPV related cervical disease is $3.5 billion.  That’s a lot of money that could be used in many other areas of prevention and treatment in our health care system.

But I am getting ahead of myself.  We don’t yet have a vaccine approved for use, and we can’t say for certain when that approval is going to be forthcoming from the FDA.  The best guestimates are sometime in late spring or early summer.

If you follow this issue closely, you are probably aware that there is already considerable discussion in the media and among various groups that have an interest in this vaccine as to when vaccination should start and who should receive it. 

For now, I am going to put aside the question of whether or not young men should receive the vaccine. One of the properties of the vaccine is that it is effective against ano-genital warts, and that is a disease that afflicts both men and women. 

There is also the question of whether we can also reduce transmission of the virus by inoculating young men, who are also carriers of the HPV virus (which, by the way, is completely asymptomatic in men and women.  This is a virus that is almost universal among sexually active men and women at some time in their lives. There are many strains of the virus, just like the flu virus.  Only a couple cause cancer, and of those even fewer are responsible for most of the cancers.  The current vaccine from Merck contains virus antigens for 2 strains that cause cancer and 2 that cause warts; another vaccine, from GlaxoSmithKline, contains the 2 cancer causing strains and not the 2 that cause warts).

The experts tell me that once you are infected with an HPV virus it is too late for the vaccine to be effective.  That means that to get the results from the vaccine, it should be administered before a woman becomes sexually active. Experts are focusing on young women in their pre-teens as the most appropriate group that should be vaccinated.

The decisions made by the FDA and the ACIP are going to be very important in determining what the right age will be.  And that means it is important for parents to understand the pros and the cons of providing this vaccine for their daughters, and possibly their sons.

There are some who are concerned that the use of this vaccine may promote sexual activity among teens (which I found out recently was much greater than I had thought).  Others say it is like wearing a safety belt, in that you don’t wear a safety belt because you believe you are going to cause an accident, but rather to protect you from someone else’s carelessness.

My purpose here is not to get into the middle of that particular discussion.  But I do want to stress how important it is for everyone who is involved in the discussion, or has a child who may be a candidate for the vaccine, to learn objective, valid information about the vaccine. The American Cancer Society is one source that will have accurate information available when you want it.

Fortunately, to date, there haven’t been reports of serious side effects associated with the vaccine.  But, as I have told my colleagues, I have never seen a vaccine or a medicine that is free of side effects, no matter how good it looks in pre-release trials.  It is one thing to vaccinate a couple of thousand people as part of a study; it is quite another to vaccinate millions of folks.  Side effects are, unfortunately, part of medicine.  We can’t avoid them, and the expectation here is that we will eventually see them with this vaccine as well.  But the early reports are certainly very encouraging that this vaccine is well tolerated.

Another point that has to be kept in mind is that cervical cancer cases and deaths are higher in medically underserved women, as well as women of color to don’t have access to regular Pap tests. 

For these reasons, the HPV vaccine has the potential to be of even greater value in these communities. This requires (demands would be a better word) that we start the dialogue and educational processes now to engage these communities.  Failure to do so will once again result in suspicion and slow acceptance of what could be a life-saving vaccination. 

If we have learned anything from past mistakes, it is that community engagement and education is needed so we can work through the process together, not pronounce it one day as a fait accompli. We need to be partners in this process if we are going to achieve the potential this vaccine has to offer everyone.

We are approaching the moment of approval with anticipation, and although no one can predict whether or not any particular vaccine or medication will be approved by the FDA, we are hopeful this application will be successful. 

Merck, as noted has already submitted its NDA.  A GlaxoSmithKline representative announced at the ACIP meeting here in Atlanta yesterday that they expect their NDA to be submitted in 2006 (no additional information was available about this comment on the company’s website).

And, if FDA approval comes before the next ACIP meeting in late June, it is possible that widespread vaccination programs could be in place shortly thereafter.

Here is hoping that we have a true success on the horizon.

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I would like to acknowledge one of my colleagues here at the Society for her efforts in keeping the society current and engaged as the vaccine story has unfolded. 

Debbie Saslow, PhD is our director for breast and gynecologic cancer and is the point "science person" responsible for helping put into place much of the Society's current activities with respect to the HPV vaccines. She has done an excellent job of preparing the Society for this issue, and helping us anticipate what we need to know and what we need to do as the hoped for approval becomes a reality. 

Dr. Saslow has also provided much of the content and knowledge on which this posting is based.