Gardasil HPV Vaccine Approved
by Jonathan Quince
Thursday, June 8, 2006 20:13:17
Bright news in a world bleak with diseases: Merck’s vaccine targeting four strains of HPV has been approved by the U.S. FDA as of June 8, 2006. According to Merck’s press release, approval is either pending or already granted in many other areas worldwide.
The quadrivalent vaccine targets two strains (16 and 18) responsible for 70% of cervical cancer incidences, as well as two others (6 and 11) that cause many cases of genital warts. If my memory serves me correctly, there are about 30 known strains of sexually transmissible HPV, including about 8 or so that can lead to cancerous effects, out of one or two hundred total known HPV strains. (The others can do things like cause warts on your fingers.)
HPV is transmitted through skin-to-skin contact; so condoms are of limited use in stopping it, and dalliances of a sapphic nature are not safe from its ravages.
Ladies, this nasty little virus—and its oncogenic effects—are the reason why you must have that annual Pap smear starting from the first time you have sex, pretty much forever. This vaccine will not eliminate the need for the Pap smear, since it only does target two of the cancer-causing strains—but it will essentially reduce by two thirds your chance of getting back heart-sinking results from your doctor, if (as noted below) you get this vaccine when you are a virgin. And men, if ye claim to be gentlemen indeed, protect your ladies: Get this vaccine and stop spreading these strains. (HPV can also lead to penile cancer, by the way, although this is much more rare than the cervical variety.)
For both men and women, the vaccine’s protection against the virus strains that cause 90% of genital warts should give pause for consideration, too.
In my view, everybody should get this vaccine unless it is specifically contraindicated for them. Although most people fail to realize this, HPV is endemic in the sexually active population. With a vaccine in our medical warchest, we can now take real steps toward eradicating four of the most common strains of this nasty and dangerous disease. In a perfect world—where vaccination was universal and all women continued to have annual Pap smears, and leaving aside the evolutionary dynamics that may be exerted on other strains—the next generation could see a 70% reduction in combined rates of cervical cancer and pre-cancerous lesions, plus a 90% reduction in genital warts. It is already well-recorded that I am a big fan of vaccines, and this is a great example of why.
Gardasil is a three-shot course over the course of six months, so starting as soon as possible would be wise. When all three shots were correctly administered, it essentially provided 100% protection during clinical trials (which is very darn good).
One caveat, though: This vaccine is only effective for people who have not yet been exposed to these strains. It should ideally be administered to people before they become sexually active, which is why the original clinical trials and the FDA’s initial approval are “for use in females 9–26 years of age”. For now, indeed, it is off-label for men and for women age 27 and up; but I cannot for the life of me think of any reason why it would be harmful. As the American pharma commercials say, “ask your doctor”. I certainly shall be asking mine; I put my body where my mouth is.
Here are some other informational details for this vaccine:
- Brand name: Gardasil®
- Generic name: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Manufacturer: Merck & Co., Inc.
- PDF: Gardasil Package Insert (Prescribing Information)
- PDF: Gardasil Patient Product Information
- Gardasil® website for patients (will probably soon host sleek ad copy)
- Gardasil® website for health care professionals (ditto, with bigger words)
GlaxoSmithKline has an HPV in the works, too; but it only targets strains 16 and 18, and it is not yet approved. When Merck’s offering shows such promise and offers tasty quadrivalence to boot, GSK’s shot seems like a non-starter to me, barring any future news that speaks contrariwise.
Thanks to Merck and to Kathrin Jansen (who spearheaded the research team) for this great news. This all dovetails into another idea I have had lately, too… But for now, it is time to stop reading, call the doctor, and get protected.
[No, I do not have cites on hand for any of the above; except for the bits from the press releases and product info sheets, it is all from memory. I am in an inexcusably lazy mood. Ask your doctor, and all that. At this writing, I am not affiliated with any of the principals involved; in any case, I would make a very odd pharma shill, indeed. ;-]