Is a 27-year old too to receive the world's first cancer vaccine?

June 8, 2006 5:29 PM

Is a 27-year old too to receive the world's first cancer vaccine?

The FDA has just approved the first cancer vaccine, Gardasil, to prevent cervical cancer, HPV, and genital warts in women who aren't already infected. The approval is for women 9-26. Why wasn't it approved for women older than that? Is there evidence it's unsafe for us, or ineffective? How restrictive is such an approval? i.e. Can the vaccine be prescribed to someone older than the approved range?

posted by nakedcodemonkey to health & fitness (14 comments total)

It's a vaccine for HPV, which can cause cervical cancer, it's not a vaccine for the cancer itself.
posted by delmoi at 5:31 PM on June 8, 2006

Random shot-in-the-dark, HPV rates are so high that they probably assume a very high percentage of older women have already been infected with a strain of HPV, and, oddly enough, many in the medical profession are hesitant to recommend treatments without a strong belief that they will be effective.

Can the vaccine be prescribed to someone older than the approved range?

Yes, this is known as an "off-label" prescription, and happens all the time.
posted by trevyn at 5:38 PM on June 8, 2006

I think it needs to be given to girls/women prior to the age when they become sexually active. Maybe 26 is just the age that researchers assumed that most (if not all) women have already become sexually active. Therefore, perhaps you have a shot if you are still a virgin....
posted by msali at 5:38 PM on June 8, 2006

From the reading I've been doing, it looks like that's just the age group they tested.

Because the overall strategy for cervical cancer prevention calls for the vaccination of preteen and adolescent girls, the investigators also attempted to determine if it would be effective and safe in this age group.

They recruited 158 healthy girls aged 10 to 14 years and 458 healthy women aged 15 to 25 years. The subjects received the vaccine at the study's onset and at months 1 and 6 after enrollment.

Other press releases talk about testing it on younger women and men. I haven't seen any mention of testing older age groups. It seems the biggest issue is that you have to be disease-free for the vaccine to work, so they're targeting people before they become sexually active (at least for now).
posted by occhiblu at 5:41 PM on June 8, 2006

Put yourself in the shoes of an investor in a biotech company. It seems counterproductive to put money into stages of increasingly expensive clinical trials for age groups that are more likely to already be infected — remember that HPV infects a number of people who do not show symptoms. If you're infected, a vaccine won't necessarily help you stave off infections. An older demographic would be a harder market to make a profit from.

Another issue is that Gardasil is an adenovirus-based vaccine. AdV-based vaccines have a few engineering problems:

• immunogenic (tend to trigger heightened immune response)


• hard to control site of infection


• high virus titer is needed (high dosage required, making it more expensive to manufacture — and sell)

Older women may have a harder time with vaccine tolerance. Added to that is the requirement of making a lot of the vaccine before being able to administer it. If you have a finite supply of the vaccine and (as mentioned above) a certain group of patients will likely be healthier in the long-term from that finite supply, then ideally you would want to target those folks.
posted by Mr. Six at 5:44 PM on June 8, 2006

The approval came for younger women because that was the focus of the clinical trials (in populations that would be vaccinated prior to infection). The FDA won't approve drugs for treatment in populations that haven't been tested.

I've seen ads recently recruiting women age 25-35 for a clinical trial for vaccinations, so researchers are working on it and there should be results in a few years. I believe they intend to test the vaccines in males eventually (or are doing it now) as well.
posted by pekala at 5:49 PM on June 8, 2006

Actually, with a bit of Googling, the recruiting in the last stage is for ages 25-45, not 35. There's information at the end of this article. The article says that hundreds of sites are participating, so maybe you can find one nearby if you'd like to contribute.
posted by pekala at 5:56 PM on June 8, 2006

This Slate article has a pretty good run-down. I think trevyn's right; they're assuming that if you've been sexually active, you've already gotten HPV, and the vaccine won't help you in this case.
posted by snickerdoodle at 6:11 PM on June 8, 2006

From CNN:
The FDA is approving the vaccine for women between the ages of 9 and 26. It was not tested in women older than 26. Later this month an advisory committee to the Centers for Disease Control and Prevention will decide on its recommendation for who should get the vaccine.
posted by j at 6:34 PM on June 8, 2006

In addition to the issue of the vaccine having not been tested on women over the age of 26, there's some evidence that vaccinating already-infected women can make the infection and risk of cancer worse:

"The vaccine may not protect people already infected and may increase their risk of the kind of lesions that can lead to cervical cancer, the FDA has said."
posted by jesourie at 6:39 PM on June 8, 2006

They're currently doing studies for women ages 26-45.... here's an article that mentions (bottom of the page):

The GSK vaccine is also now being tested on women 26-45 to determine if the protection is as good as when it's first administered to teens and pre-teens. DHMC is one of the study sites. Women interested in taking part in the project can call [phone], or e-mail [e-mail].

So maybe you could get involved with the study?
posted by strikhedonia at 7:39 PM on June 8, 2006

This link provides more information about the current trials strikhedonia mentioned. There's a list of trial sites (many in the USA and a few elsewhere) and a toll-free contact number for those who are interested.
posted by sanitycheck at 11:17 PM on June 8, 2006

I believe the reason they focused on younger women is that early age of unprotected coitarche is a particular risk for later cervical dysplasia/cancer. ie the teenage cervix is particular susceptible to the carcinogenic effects of HPV.
posted by roofus at 3:32 AM on June 9, 2006

What if you're much older than 26, but you've tested negative for HPV ??
posted by marsha56 at 10:47 AM on June 9, 2006