A vaccine that triggers immunity against those viruses that cause most cervical cancers was found to be safe and effective and should be approved soon, a federal panel recommended today. The pharmaceutical company that developed this vaccine, Merck, said the vaccine could reduce global deaths from the second leading cause of cancer in young women by more than two-thirds.
The Food and Drug Administration (FDA) advisory committee voted 13-0 on five separate occasions to endorse the Merck vaccine, Gardasil. The FDA rarely ignores its panels' recommendations when making its final decisions. The FDA decision regarding Gardasil is expected by 8 June.
The vaccine will work best in children and preteens before they become sexually active, so the recommendation will be to vaccinate girls and boys when they are as young as nine years old. Even though men are not suceptible to cervical cancer, they do act as carriers of these viruses, so vaccinating boys will help reduce transmission of the viruses throughout the population. The expense of the vaccine, which is administered in three shots over a period of six months, is estimated between $300 to $500. This will discourage widespread vaccine campaigns.
There are more than 100 types of human papillomaviruses (HPVs) known today, approximately 20 of them infect the genital tract. Gardasil is a genetically engineered vaccine that was designed to specifically protect against HPV types 6, 11, 16, and 18. HPVs 16 and 18 are linked to 78 percent of squamous cell cervical cancer and pre-cancerous cells (CIN), and HPV types 6 and 11 account for 90 percent of cases of genital warts. In the phase III trials, Gardasil was nearly 100 percent effective at preventing high-grade cervical pre-cancers and non-invasive cervical cancers (CIN 2/3 and AIS) associated with HPV types 16 and 18.
Recently, Gardasil was the focus of a lot of controversy due to political reasons: HPV is sexually transmitted and condoms do not prevent its spread. As a result, certain conservative Christian groups, such as the American Family Association, used the threat of cervical cancer, along with HIV, as a "fear factor" to argue strongly in favor of sexual abstinence outside of marriage. However, because Gardasil promises to effectively neutralize the cervical cancer "fear factor", these groups worried that young vaccine recipients would then feel free to engage in premarital sexual activity.
Eventually, the furor died down among the more rational conservatives. Unfortunately, there still are some religious wingnuts and social conservatives who apparently think that death from cancer is an appropriate punishment for young women who dared to engage in premarital sexual activity. But these extremists are in the minority.
GlaxoSmithKline is also working on a promising anti-HPV vaccine, and they are hoping for approval from US and British regulating agencies within the next year or so. I'm guessing that approval of this second vaccine might help reduce the overall expense to the public.
great news, we've been waiting for this for a long time, and it will be interesting to see what ACOG sets up in terms of guidelines. the GSK vaccine looks just as good.
Given that this is abortion/contraception related, FDA approval is most definitely not a slam dunk. The "day after pill," for example, was not approved by the FDA even though the advisory committee recommended it.
thanks for mentioning the day after pill, dave.
The conservative groups need to study psychology. Fear of long-term negative consequences generally is not effective at changing a behavior that carries a short-term reward. They may jump up and down, insisting that it ought to work, but the plain fact is, it does not.
No, the notion of punishment has nothing to do with deterrence. The punishment serves no purpose other than spite.
I agree with Dave Munger, approval still is not assured; the FDA seems to be getting increasingly puritanical lately.
I'm hoping this vaccine comes to light. Althought it won't help me (thanks, cheating boyfriend), I'm hoping it will spare future generations of girls from having to deal with the 6 month pap smears, cervical biopsies, and other pains of dealing with HPV. I'm all for medical advancements that can reduce the chance of cancer. I also agree with Joseph that the potential punishment in the future doesn't really serve to reduce activity in the majority of females. I think it's damn spiteful of certain conservative groups to wish bad things upon young women who made personal choices.
I think this belongs in the much-debated pre-conception care guidelines ...
I had intended to post my previous comment as 'llewelly', not 'ulg'.
ulg is my typekey username (because 'llewelly' was in use, not allowed, or something or other).
I did not know that if I had an active typekey cookie, the scienceblogs software would change the name I typed in - 'llewelly' to match my typekey identity.
I apologize for any confusion.
I am really puzzled that the wingnuts think HPV is the only thing standing between teenagers and naughty, evil premarital sex.
(1) Ask your average teenager (especially in these days of abstinence-only "sex ed") what HPV is, what her likelihood of contracting a strain is (very high), and what the likelihood of contracting a strain that leads to genital warts or cervical cancer is (much lower). I guarantee you the vast majority have no idea. Most adults probably don't know much about HPV or cervical cancer risks, either.
(2) HPV is not exactly high on the STI fear list. It's well below HIV and herpes. We still do not have vaccines for HIV and herpes, so there are still STIs that the wingnuts can use to scare their daughters.
And that's not even touching the psychology.
I'm crossing my fingers that the FDA won't pull a fast one here.
I assure you that I thought I was quite well-informed about sexual protection. I wasn't even having intercourse when I contracted HPV (manual/oral sex, yes, but not intercourse). I knew next to nothing about HPV until the doctor told me I had it. I know that my contemporaries in college had no clue what HPV was, and I had to explain about it for quite awhile before my friends understood why I had been so upset recently.
Cervical cancer vaccine, Gardasil, got FDA approval. At first, there was some opposition to Gardasil. There was concern that vaccinated girls may become more sexually active at a younger age. This opposition soon ebbed when people realised how many lives could be saved.