Gardasil

[Katie618]

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[happygirl]

Kate, If you could post the ingredients here, maybe we could help. *Usually vaccinations are safe though.

Also, could your pharmacist help out, if needed?

[Katie618]

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[AndreaB]

I got this following article on HPV this summer from NVIC. I get regular updates from them. You can go to nvic.org if you are interested.

It's Not Just Religious Conservatives Who Oppose Mandatory HPV Vaccination

The Missing Debate on the HPV Vaccine

OpEdNews

July 25, 2006

by Suzanne Nelson

It's not very often that conservative Christian organizations sound the voice of reason when it comes to the politics of women's health. Their positions on access to emergency contraception and the ability of pharmacists to refuse to fill birth-control prescriptions on ideological grounds -- not to mention their long-standing opposition to meaningful sex ed -- have provoked a strong and a persistent counter- push by those who believe their politics put ideology before the health and lives of women.

So the story was already written before the Food and Drug Administration announced its approval last month of Gardasil, Merck's new vaccine against the human papillomavirus, a sexually transmitted virus linked to cervical cancer. Most of the reporting has depicted Christian conservatives as once again playing politics with the FDA's approval process, just as they did with Plan B. Never mind that the Family Research Council and Focus on the Family, two leading social conservative groups, actually issued press releases supporting FDA approval of Gardasil.

Because HPV is transmitted exclusively by sexual contact, the pervasive narrative has been that delusional religious conservatives want to deny their daughters --and everybody else's -- potentially life- saving preventative medicine on the questionable grounds that it would make girls feel immune to the dangers of pre-marital sex. Predictably, women's groups and public health advocates blasted religious ideologues as needlessly sacrificing women's lives for the foolish notion that adolescents are more likely to have sex if they believe they are protected from a sexually transmitted virus that heretofore they had probably never heard of.

Yet in the process of engaging that discussion, we're not talking about whether giving the vaccine to pre- adolescent girls makes sense in terms of their overall health, the long-term safety of the vaccine or whether it should be required to enter school -- all subjects much more controversial than news coverage would have you believe. This is about sex politics. And while that's a much easier debate to frame, it's also a sideshow.

s expected, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recently put the HPV shot on its recommended childhood vaccine schedule. The shot will now become de facto required for 11- and 12- year-old girls to attend school. Some states automatically use the CDC's schedule to formulate their own requirements. If recent vaccines are any guide, most, if not all, other states will follow via legislation or regulation.

But if you listen carefully to what the largest "pro-family" groups have said, none have opposed the widespread availability of the vaccine. In fact, both FRC and Focus have advised their members of compelling reasons to give their girls the vaccine even assuming they will stay abstinent until marriage. (Some of those reasons include the very real chance their daughters' future husbands many not have abstained until marriage, as well as the possibility of rape.)

Wendy Wright, executive vice president for Concerned Women for America, said she received calls from reporters who said they heard her organization was opposing the vaccine's approval but couldn't find any statement by CWFA that indicated as much. Liberals, Wright says, "kind of jumped the gun." So if cultural conservatives haven't engaged in a systemic effort to prevent the vaccine's release -- a factual point many news organizations have blurred considerably -- then why all the fuss?

For all their panic about adolescent sex, in this debate the "pro-family" groups stand for the rather fundamental belief that parents have the right to make health decisions for their children, especially as it relates to a vaccine for a virus that is not transmitted by casual contact. It would be difficult to tell from the caricatures held up on TV and online, but the real debate is much more substantive than the one we've been having about whether the vaccine will encourage sex outside of wedlock. And if discussed honestly, we would also have a much better chance of finding common ground than any battle in the culture wars.

Christian conservatives -- by once again driving themselves to distraction over premarital sex -- may have actually stumbled upon a position that aligns themselves with, dare we say, choice. HPV is not a virus a kid catches by sitting next to someone at school. It is not spread by sharing juice boxes or trading germs on the bus. That makes this vaccine completely different from the 14 others on the CDC's recommended schedule, save perhaps Hepatitis B, which is primarily (but not exclusively) transferred via intravenous drug use and sexual contact.

Both vaccines aim to protect people from a virus that is basically only transmitted when a person engages in what amounts to optional behavior. (Hepatitis B can also be transmitted from mother to child if the mother is carrying the virus. Regardless of the mother's infection status, however, all babies are given that vaccine at birth.) HPV is not a public health threat in the same way, say, polio is. And that gives state governments much less of a compelling interest to mandate that children be vaccinated for it.

Let's put aside for the purposes of discussion the bizarrely controversial notion that parents should be able to decide what enters their children's body via injection, especially when that shot carries the risk of harm or death. HPV does not lurk in the air, in swimming pools or on playground equipment. That makes the vaccine's public health credentials dubious at best.

Yes, 3,700 women in the United States die of cervical cancer every year. But just having HPV doesn't mean you're going to get cancer. The FDA said as much in its press release: "For most women, the body's own defense system will clear the virus and infected women do not develop related health problems." Estimates of the number of people with HPV in the United States vary wildly, but perhaps up to 80 percent of women are infected with HPV at one time or another before they are 50.

Yet given that high incidence, the number of women who develop cervical cancer is pretty low, about 10,000 cases each year. Pap smears usually catch abnormal cells before cancer has progressed, when women are treated with extraordinarily high rates of success. According to Dr. Herschel W. Lawson of the CDC, the greatest risk factor (60 percent) for cervical cancer in the U.S. is not being screened or being screened at intervals greater than 5 years.

So uncommon is cervical cancer in the United States that it is listed as a rare disease by the National Institutes of Health. That's not to say that it's not painful or tragic for thousands of women, but it's nonetheless relatively rare. There's a reason that just about every prediction about a reduction in cervical cancer due to the HPV vaccine is reported as a worldwide statistic. The numbers in the U.S. are just not that high as a percentage of the population.

Most women in the U.S. who develop invasive cervical cancer have not had regular pap smears, according to the CDC. So to say that because 3,700 women in the United States die of cervical cancer every year, and thus there's an urgent public-health need to vaccinate every adolescent girl -- without mentioning that many if not most of those women did not have regular screenings -- is somewhat disingenuous.

But even if the vaccine proves to be successful at reducing overall HPV infection, and the reduced number of HPV infections lead to a correlating decline in cervical cancer cases -- both still assumptions at this point, as the vaccine hasn't been studied nearly long enough to determine that -- some parents still may not want to give it to their daughters. For starters, it could cause harm. All vaccines carry the risk of injury or death.

Additionally, the FDA's insert reveals that nine people developed arthritis after receiving the vaccine versus three for the placebo, out of approximately 21,000 individuals in that trial. Nine kids with arthritis after receiving the vaccine might not seem like a big deal in the grand scheme of things. After all, arthritis is better than cancer, right? That depends. Given the fact that cervical cancer is relatively rare, highly preventable and most often successfully treated early on, maybe the risk of arthritis -- a painful and often debilitating disease -- isn't a worthwhile tradeoff. Isn't that for parents to decide?

And maybe we won't know the true incidence of harmful effects until the vaccine is given to millions, rather than thousands, of children and young adults. Participants in the Gardasil studies were monitored for, at most, four years and many for a considerably shorter time frame. The largest trial is scheduled to be ended early and the people who were given a placebo now will be given the vaccine, meaning it's no longer possible to study long-term differences in health between those who received the vaccine and those who received the placebo.

In terms of long-term safety, one sentence in the FDA's insert is particularly revealing. "Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity," according to the insert. Yes, carcinogenicity means the ability to cause cancer. It's also not known whether the vaccine can cause chromosomal damage. We don't know because researchers didn't look. The trials were not set up to examine that question.

Additionally, five participants in the trial who were given the vaccine near the time of conception went on to give birth to babies with birth defects versus zero cases of congenital anomalies in the group that received the placebo. This is hopefully not an issue for many 11-year-olds, but it could impact teenagers and certainly young women who get the vaccine. The insert states that Gardasil is not recommended for use in pregnant women, but are pregnancy tests going to be routinely given before the vaccine is administered? Only time and widespread use will reveal whether those five babies born with birth defects reveal a pattern.

As a condition for Gardasil's approval, Merck agreed to monitor the "pregnancy outcomes" of women who receive the vaccine while unknowingly pregnant, along with general safety issues. But drug companies have had a poor track record on actually completing the post-licensure follow-up studies required by the FDA, according to the agency's own figures. The FDA announced in March that two-thirds of those promised studies had not even been started, and hundreds of trials have been pending for years. The agency has little leverage to force the companies to comply, according to a report by the Government Accountability Office. In many of those cases the companies received expedited approval from the agency on condition that the studies be carried out. Gardasil was approved on just such an expedited timeline.

So if this vaccine turns out to have safety issues are we even going to know? Or is it going to remain on the states' mandatory list long after many girls suffer serious side effects or worse? What about the safety of giving Gardasil at the same time as the meningococcal and diphtheria, tetanus and pertussis vaccines, shots 11- and 12-year-olds receive during the same visit to the doctor? Merck looked at the safety of administering the HPV vaccine at the same time as Hepatitis B, but what about the safety of concurrent vaccination with DPT, or any other combination of vaccines the kids could be "caught up" on during that visit?

The CDC's vaccine advisory committee also said the vaccine could be given to girls as young as nine, at the direction of the physician. The rationale for doing so is that the vaccine is only effective prior to exposure to HPV and actually leads to increased risk of precursors to cervical cancer in those previously infected, so it's best to catch girls as early as possible. Yet only 250 9-year-olds received Gardasil in trials, adding to the unknowns about administering a vaccine on still developing bodies. Shouldn't parents be permitted to weigh such considerations when making health decisions for their children?

Merck had an enormous amount at stake in making the shots mandatory. A place on states' required lists means a steady and exponentially larger revenue stream. Financial analysts predict Gardasil could be Merck's most important pipeline contributor to top- line growth, with peak sales of at least $2 billion -- revenue Merck badly needs after the Vioxx scandals. That revenue figure assumes that states will make Gardasil mandatory. The CDC's support also all but guarantees insurance reimbursement, as well as state and federal funding. Perhaps more importantly, it also gives Merck coverage under a federally funded vaccine liability program. If Gardasil turns out to have devastating or deadly consequences, Merck isn't liable.

"It's a stockholders dream," said Barbara Loe Fisher, president of the NVIC, a nonprofit that promotes right to informed consent on vaccine decisions. Fisher sat on the FDA's committee that reviews vaccines in 2001, when the vaccine underwent early reviews. "This has nothing to do with kids and whether they are going to have sex," Fisher added. "It has to do with whether they are going to be set up for chronic inflammatory disease" from yet another vaccine being added to the litany of those they already receive. "I would want more data on long-term effects of autoimmunity on certain genotypes," she said in an interview, "and whether this vaccine is going to harm far more girls than it is going to protect."

In a recent study published in the journal Pediatrics, 35 percent of parents surveyed were against having their children vaccinated for HPV. Safety was their primary concern. Although the study didn't specifically look at whether that resistance was tied to a fear that the shot would make their kids more likely to have sex, are we really going to deny parents the right to make an informed choice?

Beyond touting the misleading public-health argument, many progressive organizations have asserted that leaving HPV off the CDC's recommended schedule means that the resulting lack of public funds will prevent many poor kids from having access to it. If that's the only objection, then another public funding avenue could be devised to get the vaccines to those who want them and couldn't otherwise afford the $360 price tag.

Yet, at its core, the argument for mandatory use is really about something else. It was recently summed up aptly, if inadvertently, by Joe Kernan, anchor of CNBC's Squawk Box. He moderated a segment last month on whether Gardasil should be mandated. He said: "Parents aren't necessarily going to do the right thing. They might not even ... they might space. They might not take the time to get this done. There's a lot of reasons this wouldn't be done. Shouldn't we just do it with the kids, get it out of the way, no one gets cervical cancer?"

If only it were that simple. His essential point -- that parents are too stupid or too lazy to figure out this issue for themselves and thus the government should step in -- highlights a consistent criticism conservatives have about liberals. So perhaps it's not surprising that conservative groups have argued that mandating the HPV vaccine isn't the government's place. But looked at another way, ultimately this is about an intrusive government versus one that doesn't meddle in the affairs of women's bodies. That's a principle progressives usually fall all over themselves to support.

The protracted debate about whether the HPV vaccine will make adolescent kids more likely to have sex is largely irrelevant. If some parents decide that possibility is reason enough to forgo the shot, however, isn't such their right -- regardless how foolish others may think their reasoning? Linda Klepacki of Focus on the Family replied to Kernan's remarks with a simple statement: "Parents have the right to be the decision-makers for their children, especially when it comes to medicine."

Indeed.

[Katie618]

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[Jestgar]

it will help rid of the HPV you might already have, it is safe-

I actually heard that the opposite was true. Has anyone seen studies or a legitimate source about this?

[Jestgar]

Here's the FDA site.

Open Original Shared Link

[mommida]

although i appreciate your intentions, that wasn't the information i was looking for.

- my dr. explained to me ..., it will help rid of the HPV you might already have, ?????

I think you should read the information on this vaccine. The reason they want to vaccinate nine year-old girls is they think the nine year-olds haven't been infected yet. If you are all ready infected there is no protection from the HPV types the vaccine is for. ( Which is about four out of thirty known types of HPV)

The long term affects of the vaccine are unknown.

You must read the vaccine package insert to make an informed decision. The ingredients, the effiency rate, the contraindications, should all be taken into consideration.

L.

[Jestgar]

The reason they want to vaccinate nine year-old girls is they think the nine year-olds haven't been infected yet. If you are all ready infected there is a possibility of excerbating the condition.

The long term affects of the vaccine are unknown.

This is what I heard as well. The FDA site doesn't say anything about making anything worse so I'm not sure if this is speculation or if they feel it is a real risk.

[elonwy]

This is the information I was looking for:

# Will Gardasil help a female who already has a vaccine type HPV?

In the studies, females with current or past infection with one or more vaccine-related HPV types prior to vaccination were protected from the diseases caused by the other remaining HPV types contained in the vaccine.

So it doesn't help with anything you would already have, it just keeps you from getting other types.

I didn't realize there were so many kinds of HPV.

Seems to be gluten-free, though.

[AndreaB]

Jestgar,

This article has reference to adverse reactions from the shot. A link is included to get the full report at the bottom of the letter.

June 27, 2006

MERCK'S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS

National Vaccine Information Center Criticizes FDA for Fast Tracking

Licensure

Washington, D.C. - The National Vaccine Information Center (NVIC) is

calling on the CDC's Advisory Committee on Immunization Practices (ACIP) to

just say "no" on June 29 to recommending "universal use" of Merck's Gardasil

vaccine in all pre-adolescent girls. NVIC maintains that Merck's clinical

trials did not prove the human papillomavirus (HPV) vaccine designed to

prevent cervical cancer and genital warts is safe to give to young girls.

"Merck and the FDA have not been completely honest with the people about

the pre-licensure clinical trials," said NVIC president Barbara Loe Fisher.

"Merck's pre and post-licensure marketing strategy has positioned mass use

of this vaccine by pre-teens as a morality play in order to avoid talking

about the flawed science they used to get it licensed. This is not just

about teenagers having sex, it is also about whether Gardasil has been

proven safe and effective for little girls."

The FDA allowed Merck to use a potentially reactive aluminum containing

placebo as a control for most trial participants, rather than a non-reactive

saline solution placebo. A reactive placebo can artificially increase the

appearance of safety of an experimental drug or vaccine in a clinical trial.

Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have

been used in vaccines for decades, they were never tested for safety in

clinical trials. Merck and the FDA did not disclose how much aluminum was in

the placebo.

Animal and human studies have shown that aluminum adjuvants can cause

brain cell death and that vaccine aluminum adjuvants can allow aluminum to

enter the brain, as well as cause inflammation at the injection site leading

to chronic joint and muscle

pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85

percent of

aluminum placebo recipients reported one or more adverse events within 15

days of

vaccination, particularly at the injection site. Pain and swelling at

injection site and fever occurred in approximately 83 percent of Gardasil

and 73 percent of aluminum placebo recipients. About 60 percent of those who

got Gardasil or the aluminum placebo had systemic adverse events including

headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil

recipients had more serious adverse events such as headache,

gastroenteritis, appendicitis, pelvic inflammatory disease, asthma,

bronchospasm and arthritis.

"Merck and the FDA do not reveal in public documents exactly how many 9

to 15 year old girls were in the clinical trials, how many of them received

hepatitis B vaccine and Gardasil simultaneously, and how many of them had

serious adverse events after being injected with Gardasil or the aluminum

placebo. For example, if there were fewer than 1,000 little girls actually

injected with three doses of Gardasil, it is important to know how many had

serious adverse events and how long they were followed for chronic health

problems, such as juvenile arthritis."

According to the Merck product manufacturer insert, there was 1 case of

juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis,

and 1 case of reactive arthritis in 11,813 Gardasil recipients plus 1 case

of lupus and 2 cases of arthritis out of 9,701 participants primarily

receiving an aluminum containing placebo. Clinical trial investigators

dismissed most of the 102 Gardasil and placebo associated serious adverse

events, including 17 deaths, that occurred in the clinical trials as

unrelated.

"There is too little long term safety and efficacy data, especially in

young girls, and too little labeling information on contraindications for

the CDC to recommend Gardasil for universal use, which is a signal for

states to mandate it," said Fisher. "Nobody at Merck, the CDC or FDA know if

the injection of Gardasil into all pre-teen girls - especially

simultaneously with hepatitis B vaccine - will make some of them more likely

to develop arthritis or other inflammatory autoimmune and brain disorders as

teenagers and adults. With cervical cancer causing about one percent of all

cancer deaths in American women due to routine pap screening, it was

inappropriate for the FDA to fast track Gardasil. It is way too early to

direct all young girls to get three doses of a vaccine that has not been

proven safe or effective in their age group."

The National Vaccine Information Center (NVIC), founded in 1982 by

parents of vaccine injured children, has been a leading critic of

one-size-fits-all mass vaccination policies and the lack of basic science

research into biological mechanisms and high risk factors for

vaccine-induced brain and immune system dysfunction. As a member of the FDA

Vaccines and Related Biological Products Advisory Committee (VRBPAC),

Barbara Loe Fisher urged trials include adequate safety data on

pre-adolescent children and warned against fast tracking Gardasil at the

November 28-29, 2001 VRBPAC meeting

Open Original Shared Link

Vaccines & Related Biological

For references and more information, go to www.nvic.org.

Here's another excerpt from July 28 that talks about a few women that had babies with birth defects who had got the shot prior to conception. Whether the shot caused them, who knows for sure.

In terms of long-term safety, one sentence in the FDA's insert is particularly revealing. "Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity," according to the insert. Yes, carcinogenicity means the ability to cause cancer. It's also not known whether the vaccine can cause chromosomal damage. We don't know because researchers didn't look. The trials were not set up to examine that question.

Additionally, five participants in the trial who were given the vaccine near the time of conception went on to give birth to babies with birth defects versus zero cases of congenital anomalies in the group that received the placebo. This is hopefully not an issue for many 11-year-olds, but it could impact teenagers and certainly young women who get the vaccine. The insert states that Gardasil is not recommended for use in pregnant women, but are pregnancy tests going to be routinely given before the vaccine is administered? Only time and widespread use will reveal whether those five babies born with birth defects reveal a pattern.

As a condition for Gardasil's approval, Merck agreed to monitor the "pregnancy outcomes" of women who receive the vaccine while unknowingly pregnant, along with general safety issues. But drug companies have had a poor track record on actually completing the post-licensure follow-up studies required by the FDA, according to the agency's own figures. The FDA announced in March that two-thirds of those promised studies had not even been started, and hundreds of trials have been pending for years. The agency has little leverage to force the companies to comply, according to a report by the Government Accountability Office. In many of those cases the companies received expedited approval from the agency on condition that the studies be carried out. Gardasil was approved on just such an expedited timeline.

So if this vaccine turns out to have safety issues are we even going to know? Or is it going to remain on the states' mandatory list long after many girls suffer serious side effects or worse? What about the safety of giving Gardasil at the same time as the meningococcal and diphtheria, tetanus and pertussis vaccines, shots 11- and 12-year-olds receive during the same visit to the doctor? Merck looked at the safety of administering the HPV vaccine at the same time as Hepatitis B, but what about the safety of concurrent vaccination with DPT, or any other combination of vaccines the kids could be "caught up" on during that visit?

The CDC's vaccine advisory committee also said the vaccine could be given to girls as young as nine, at the direction of the physician. The rationale for doing so is that the vaccine is only effective prior to exposure to HPV and actually leads to increased risk of precursors to cervical cancer in those previously infected, so it's best to catch girls as early as possible. Yet only 250 9-year-olds received Gardasil in trials, adding to the unknowns about administering a vaccine on still developing bodies. Shouldn't parents be permitted to weigh such considerations when making health decisions for their children?

[Jestgar]

Yes, I kind of read through this the first time you posted it and I have to say I'm not really sure where I stand on the vaccine.

I think that some of the arguments aren't valid with regard to Gardasil, because they question the use of aluminum in the placebo, which is a different concern. (Yes, I know it's in the vaccine as well, but they don't give reference numbers so that you can tell whether 225mcg of aluminum is a lot, and if that refers to one shot, or a whole vial.

"Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse

events, including 17 deaths, that occurred in the clinical trials as unrelated."

They could have been hit by cars or gotten food poisoning or fallen of a bridge. The presentation of this sentence makes it sound as if Merck and the FDA are deliberately hiding results (which they could be doing, but it would be a lot sneakier than this).

""Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity," according to the insert. Yes, carcinogenicity means the ability to cause cancer. It's also not known whether the vaccine can cause chromosomal damage. We don't know because researchers didn't look. The trials were not set up to examine that question."

This would be incredibly hard to do, as many viruses insert themselves into your genome. I don't know what the stats are for normal HPV viruses to do this, but they obviously do, hence the cancer. This sentence is almost a wash. Even if the vaccine is equally as tumorogenic as the virus, it's unlikely to be worse.

When information is presented in a way designed to scare people, instead of inform them, I tend to take it less seriously.

I still have only seen "reports" about Dr Miller saying the vaccine could exacerbate current HPV infections. I haven't seen any direct quotes from her.

[Katie618]

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[elonwy]

Hey- I wasn't attacking you. I'm trying to figure out if I can get the vaccine or not, as I have had HPV. Your comment was interesting to me, and I went to the FDA website to get more information for myself, and posted what was relevant so as to further discussion.

I think the HPV vaccine is awesome, I just want to make sure I can get it without getting MORE sick, since I've already had HPV. I'm here for the same reason you were, but we'd already settled the gluten-free question.

The article doesn't interest me, because it's mostly opinion. Because of your statements, I'm more interested in talking to my doctor about the vaccine, so thank you.

I'm sorry you felt I was attacking you.

Elonwy

[Jestgar]

I'm pretty sure I just asked if any else had concrete information.

I think Andrea and I are just posting different viewpoints. I know that I don't know the facts, and I appreciate that she and others take the time to present opposing viewpoints.

[AndreaB]

I hope my posts weren't perceived as attacking anyone.

I'm just presenting what NVIC has.

Whether to vaccinate is a personal decision.

[Jestgar]

excerpts from "The American Journal of Managed Care" December 2006

Worldwide, cervical cancer is second only to breast cancer as the leading cause of cancer-related mortality in women.

Cervical cancer represents the eleventh most frequent cancer in the United States and was responsible for more than 3500 deaths in the United States in 2005; more than 10 000 new cases were diagnosed during that year alone.

It was discovered that L1 proteins were capable of self-assembling into virus-like particles (VLPs) when expressed in cells. These VLPs share great similarity to native HPV virions, are noninfectious and nononcogenic, and can induce high levels of neutralizing antibodies; vaccination with VLPs has protected against HPV infection in animal models.

CIN1 represents low-grade dysplasia, which is not thought to be a true cancer precursor, whereas CIN2 and CIN3 are moderate-and high-grade dysplasias, respectively, and immediate precursors of cervical cancer. In keeping with these outcome markers, a controlled proof-of-principle efficacy study (n = 2392) conducted by Koutsky et al13 demonstrated 100% efficacy of an HPV-16 VLP vaccine in women. All cases of new HPV-16 infections, including HPV-16-related CIN, occurred in the placebo group. Additional follow-up of these patients revealed protection against persistent infection and HPV-16-related CIN2-3 for an average of 3.5 years.

Cervarix and Gardasil differ with respect to adjuvants. The former uses AS04 (aluminum hydroxide plus 3-deacylated monophosphoryl lipid A [MPL]), whereas the latter employs amorphous aluminum hydroxyphosphate sulfate. It is unclear if greater and more sustained antibody responses are obtained with the AS04 adjuvant compared with aluminum salt-based adjuvants without MPL, as some investigators suggest.

Approval of Gardasil in very young girls was not based on clinical efficacy, but rather "bridging immunogenicity and safety studies," where efficacy was inferred from immunologic responses in women aged 9 to 15 years of age when compared with immunologic responses in women aged 16 to 26 years of age with known efficacy against HPV disease. Significant antibody responses were seen in more than 99% of these girls, and were higher than those observed in 16-to 26-year-old women.

Specific Targeted Populations

Young Girls. Infection with HPV is highly prevalent in the United States. More than half of men and women in the United States will be infected during their lifetime, with most infections occurring in the teens and early 20s; most women acquiring infection will contract HPV shortly after becoming sexually active. CDC data indicate that approximately a quarter of all girls in the United States have had sexual intercourse before the ninth grade; high rates of HPV infection also accumulate in women during college years.7 Thus, the ideal time for vaccine administration is before the onset of sexual activity, with the most apparent population being preteens, which is consistent with ACIP recommendations. As previously indicated, immunogenic responses are greater in young girls compared with older women.

Preliminary data suggest that HPV VLP vaccines in women with pre-existent infection with vaccine-oncogenic types of HPV may prove beneficial. Limited studies have reported a significant antibody response to the HPV-6,11,16,18 L1 VLP vaccine and the HPV-16 L1 VLP vaccine in women with vaccine-type antibodies at baseline; levels were higher and more persistent compared with baseline HPV na

[mommida]

I'm not trying to attack anyone.

I feel the best place to find answers to particular vaccine questions is to start with the vaccine package insert.

I have read articles that have the opposite viewpoint, may help or may exacerbate previous HPV infection.

I wish everyone would ask more questions and make an informed decision.

[mommida]

posted

[Electra]

I got this following article on HPV this summer from NVIC. I get regular updates from them. You can go to nvic.org if you are interested.

Wow thanks so much for posting that article. I was thinking about asking my dr. about the vaccine, but I didn't realize that HPV was sexually transmitted. I guess I don't need it so I'm definitely safe on this one

Oh I missed the age deadline too so I must be an "OLD LADY" Now Hehe.

[elonwy]

I didn't even see the age deadline the first time. Guess its not for me either.