Vaccines

HPV Vaccine Adverse Effects Summary

 

This Summary is loosely arranged as follows:

** NVIC and VAERS reports on the dangerous adverse effects of HPV Vaccinations, 2006-2010
** Transcript Analysis of Merck's 2006 Meeting
** JAMA Article excerpts
** Med Institute Statement on HPV Vaccine
** Questionable Safety
** Questionable Cost
** Questionable Purpose
** Questionable Motivation
** Harper, Lead Researcher Statements

This summary does not touch on the moral and ethical concerns of the HPV vaccines (Gardasil and Cervarix), many as there may be.

Parents Need to Evaluate Thoroughly and Carefully for the Good of their Children…

A BRIEF SUMMARY OF ADVERSE EFFECTS OF HPV VACCINE GARDASIL

This summary does not touch on the moral and ethical concerns of the HPV vaccines (Gardasil and Cervarix), many as there may be.

This summary primarily is a cut and paste of two chronological pages:

HPV Vaccine: Updates 2008 – 2011

HPV Vaccine: 2006 – 2007

Please peruse these webpages in their entirety for a better overall view of the concerns presented by these vaccines.

This summary is loosely arranged as follows:
** NVIC and VAERS reports on the dangerous adverse effects of HPV Vaccinations, 2006-2010
** Transcript Analysis of Merck's 2006 Meeting
** JAMA Article excerpts
** Med Institute Statement on HPV Vaccine
** Questionable Safety
** Questionable Cost
** Questionable Purpose
** Questionable Motivation
** Harper, Lead Researcher Statements
** Parents Need to Evaluate Thoroughly and Carefully for the Good of their Children

***

Gardasil was released for use in mid-2006. The National Vaccine Information Center (NVIC) released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006.

Of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL.

[NOTE: To be completely immunized, women and girls have to receive a series of three injections over six months. Many women and girls didn’t do so. For example, according to the U.S. Center for Disease Control, in their report of August 2010, although 44% of teenagers had received the HPV vaccine in 2009, only 27% of them received all three doses of the vaccine.]

NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.
***

Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to HPV Vaccination Gardasil.
This covers approximately the first 11 months of public use of the HPV Vaccine. (Judicial Watch filed its request on May 9, 2007, and received the adverse event reports from FDA on May 15, 2007.)  Judicial Watch has posted the adverse event reports on their Internet site at: http://www.JudicialWatch.org

Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil.Three deaths were related to the vaccine. One physician's assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine."

Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting. As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) included 371 serious reactions.

Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormalities. Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.

"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors," stated Judicial Watch President Tom Fitton. "Any state or local government now beset by Merck's lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports. It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug."

Serious reactions attributed to HPV vaccine.
Causes of death were myocarditis, coronary artery thrombosis, and pulmonary embolism. Two of the deaths were of girls aged 12 and 19 years.
The interval from vaccination to death ranged from several hours to about 2 weeks.
[23May07, DC, LifeSiteNews.com], 24May07, Association of American Physicians and Surgeons, Inc., http://www.aapsonline.org/nod/newsofday429.php]
***

As of August 2007, a review of the National Vaccine Information Center revealed the following, quite alarming, statistic about this unnecessary vaccine: 2,207 adverse reactions to Gardasil have been reported. Among them:
 
    * 5 girls died
    * 31 were considered life-threatening
    * 1,385 required a visit to the emergency room
    * 451 of the girls have not recovered as of July 2007
    * 51 of the girls were disabled

***
Slightly different statistics from the US Government's Vaccine Adverse Event Reporting System (VAERS) database through the end of July, 2007, indicates that there have been 7 deaths associated with administration of Gardasil.
Age is listed for four of the girls who died at: 11, 12, 15 and 19. VAERS lists 3,137 reported adverse effects stemming from Gardasil. The database is voluntary and thus is unlikely to include all adverse effects from the vaccine.
 
The database, placed online by the National Vaccine Information Center, also indicates 44 adverse effects associated with the vaccine's administrati

on were considered "life threatening".  In 1921 cases, vaccine recipients visited the ER; in 94 cases, vaccine recipients required hospitalization and 20 recipients had extended stays in the hospital.

Of the total, 1530 are known to have recovered; how much cost and physical and emotional trauma were involved in this experience may never be evaluated.
 To search the database online visit:  http://www.medalerts.org/vaersdb/index.html
[LifeSiteNews.com, 28Sept07]
***

Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil Since September 2007 (8,864 total Adverse Events)

The organization's work uncovered reports of about one death each month since last fall, bringing the total death toll from the drug to at least 18 and as many as 20.

There also were 140 "serious" reports of complications including about three dozen classified as life-threatening, 10 spontaneous abortions and about 6 cases of Guillain-Barre Syndrome.

The document reveals the case of an 18-year-old woman who got the Gardasil vaccine, was found unconscious that evening, and died. Another woman, age 19, got the drug and the next morning was found dead in her bed.

The new documents also reveal a total of 8,864 Vaccine Adverse Event Reporting System records, up from a total of 3,461 that had been reported in a document just last fall.
***

CDC website:
    As of December 31, 2008, there have been 32 U.S. reports of death among females who have received the vaccine.
***
To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse effects include Guillain-Barre syndrome, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths. [sometime in 2009]

Dr. Harper, lead researcher of the HPV vaccine, who seems to specialize in dropping bombshells, dropped another in an interview with ABC News when she admitted, “The rate of serious adverse events is greater than the incidence rate of cervical cancer.”

This being the case, one might want to take one’s chances with cancer, especially because the side effects of the vaccine are immediate, while the possibility of developing cancer is years in the future.

In the clinical studies alone, 23 girls died after receiving either Gardasil or the aluminum control injection. 15 of the 13,686 girls who received Gardasil died, while 8 died among the 11,004 who received the aluminum shot.

There was only one death among the group that had a saline placebo. What this means is that 1 of every 912 who received Gardasil in the study died (see page 8 of Merck’s prescribing information).

The cervical cancer death rate is 1 of every 40,000 women per year.

The numbers of deaths and adverse effects are undoubtedly underestimates…
On average, less than 10 percent of serious vaccine adverse events are ever reported, according to the American Journal of Public Health…

Due to the young age of the trial participants and the short duration of the studies, the effects of Gardasil on female fecundity have not been studied.

Possible Infertility Effect?

I did discover, in my post-conference reading, that Polysorbate 80 (sometimes referred to as “Tween 80”), an ingredient in the vaccine (see page 14 of Merck’s prescribing information)  has been observed in a European clinical study to cause infertility in rats.

Is this — infertility — an additional concern? Time will tell…

***

September 28, 2010
Judicial Watch Uncovers FDA Records Detailing 16 New Deaths Tied to Gardasil: Records Document 3,589 Adverse Reactions Related to Gardasil between May 2009 and September 2010, Including 213 Cases Resulting in Permanent Disability
[This is NOT the total since mid-June 2006; this is only May 2009 – Sept 2010]
***

The incidence of arthritis was three times greater among those given Gardasil than in the placebo group.

The National Vaccine Information Center reported, "There were twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a Tdap (tetanus-diptheria-acellular-pertussis) vaccination.

There have been reports of facial paralysis and Guillain-Barre syndrome, a disorder in which the body's immune system attacks part of the peripheral nervous system.

Effect on Pregnancies

Can Gardasil cause harm to an unborn child or affect reproductive capacity? In pregnancies that began within 30 days following an innoculation, five cases of congenital anomaly occurred in the Gardasil group while none occurred in the placebo group.

Effect on Existing HPV Infection

Examining Merck's clinical trial data, FDA staff noted that vaccinating women who are already infected with strains of HPV targeted by Gardasil may actually worsen their cervical disease.

Yet testing for prior HPV infection before vaccination is not now being done or recommended.

FDA staff also questioned whether other high risk strains not targeted by the vaccine could become more dominant after Gardasil suppresses the two most prevalent strains. For example, some of the seven strains of pneumococcus in Prevnar, a vaccine recommended for universal use in babies in 2000, were offset by some of the more than 80 other pneumococcal strains not contained in the vaccine.
[Susan E. Wills, NCR, March 18-24, 2007]
***


TRANSCRIPT ANALYSIS OF MERCK'S MEETING WITH VRBPAC
Judicial Watch uncovered a transcript of Merck's May 18, 2006, meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC), at which the vaccine received a unanimous vote of approval. Analysis of the records shows:

. Gardasil is a prophylactic, preventative vaccine and will not treat pre-existing HPV infection. It is not a cancer vaccine or cure.

. Gardasil is marketed as a vaccine that prevents cancer, but it " . . . has not been evaluated for the potential to cause carcinogenicity or genotoxicity."

. Gardasil is not 100% effective against all HPVs. It is designed to protect against only four strains of HPV, even though there are over thirty strains including at least fifteen that can cause cancer.

. While Gardasil is the most expensive vaccine ever to be recommended by the FDA, its long-term effectiveness is unknown and could be as brief as only two to three years.

. During testing, an aluminum-containing placebo was used. Aluminum can cause permanent cell damage and is a reactive placebo, unlike most standard saline placebos. This means that tests of Gardasil may not have given an accurate picture of safety levels.

. Although some states are considering making it mandatory for young girls to get the Gardasil vaccine, it has only been tested with one other vaccine commonly given to children. There are ten commonly administered adolescent vaccines.

. Gardasil is still in the testing stages, and will
not be fully evaluated for safety until September 2009.
VAERS reports show that as many as eighteen people have died after receiving Gardasil.

See full report:
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf
***

JAMA ARTICLE EXCERPTS
For more on Gardasil, see JAMA article (free full text) “The Risks and Benefits of HPV Vaccination,” by Charlotte Haug MD, PhD, MSc

From the abstract: “Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain.

"Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.
When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the balance.

"If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.”
[ http://jama.ama-assn.org/cgi/content/full/302/7/795?home ]
***

MED INSTITUTE'S STATEMENT ON HPV VACCINE
5 February 2007
The Medical Institute's Statement on HPV Vaccine

An HPV (human papillomavirus) vaccine[1] received FDA approval in June 2006. This vaccine is intended to provide immunity against four common HPV types – 16, 18, 6, & 11.

Scientific evidence on immunization with the quadrivalent vaccine suggests that it substantially reduces the risk of pre-cancer and cancer of the cervix caused by HPV types 16 & 18[2,3,4] (responsible for ~70% of all cervical cancers in the US)[5], substantially reduces the risk of genital warts caused by HPV types 6 & 11[6] (responsible for ~90% of all genital warts in the US)[7], and is cost effective when administered to adolescent females[8].

However, there is NO EVIDENCE to suggest that the vaccine…

–reduces the risk for cervical cancers caused by other HPV types (responsible for ~30% of all cervical cancers in the US)

–reduces the risk of other sexually transmitted infections (STIs)

–offers any protection against the other consequences of nonmarital sexual activity such as pregnancy and emotional damage.

Furthermore,
–currently the duration of immunity following immunization is unknown
–the role of the vaccine for males is uncertain

Therefore, we promote abstinence for unmarried persons as a primary method to prevent pregnancy,[9,10] STIs including HIV,[11] and the emotional consequences of sexual activity[12];

we promote monogamy as a primary method to prevent STIs including HIV[13]

–encourage further research into the duration of immunity and the optimal timing of immunization
–recommend continued regular health screening and counseling including pelvic examinations, Pap tests, and appropriate STI screening

Finally, we encourage physicians to counsel all their patients regarding sexual health.
***

QUESTIONABLE SAFETY
According to the National Institutes of Health National Cancer institute, in more than 90% of the cases, HPV infections are harmless and go away without treatment. [2]

Also, according to the CDC, most cervical cancer can be prevented and cervical cancer is very rare in women who get regular PAP tests.[3] 

The CDC says there are more than 100 strains or types of HPV and over 30 strains are sexually transmitted. [5] Yet [Gardasil] covers only 4 strains. [6]   Merck says that about 30% of cervical cancers can’t be prevented by the vaccine, so women will still need regular cervical cancer screenings. [7].

The only current vaccine manufacturer for the HPV vaccine, Merck, admits on their package insert that the duration of immunity from the vaccine is unknown. [8]  In clinical trials, the vaccine’s effectiveness was followed for 4 years.[9]  Yet we do know from the CDC that the incubation period for the HPV virus is about 20 years [10] and the median age of women diagnosed with cervical cancer is 48 [11].

Therefore, no claims to proof of cervical cancer prevention by vaccinating preteen girls should be made.

The HPV vaccine Gardasil was approved by the FDA on June 8, 2006 after 6 months of review.[12]  It has been on the market for less than 1 year.

The chairman of the American Academy of Pediatrics committee on infectious diseases was quoted in the Washington Post in response to a proposed mandate in Washington D.C. saying that he thought it was premature to recommend making the vaccine mandatory. "I think it's too early," said Joseph A. Bocchini,…"This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine." [13]

Dr. Martin Meyers, director of the National Network for Immunization Information, was quoted in the Baltimore Sun in response to a proposed bill in Maryland to mandate HPV vaccines for 6th grade girls, “A lot of us are worried it's a little early to be pushing a mandated HPV vaccine."  He also said "It's not the vaccine community pushing for this."

The article spotlighted HPV vaccine manufacturer Merck’s aggressive role in pushing for a mandate where across the U..S., HPV vaccine mandates could mean $4 billion dollars in sales for Merck [14] who is currently plagued by lawsuits for withholding critical safety information to doctors and patients about their popular painkiller drug Vioxx.[15]

The FDA’s Vaccine Adverse Events Reporting System has already received 82 reports of serious adverse events following HPV vaccination with Gardasil since its approval last June. [16]

More questions remain.  Disclaimers printed on the manufacturer’s package insert state that the vaccine has not been tested for it’s own ability to cause cancer [17] and the effect on a woman’s reproductive capacity is unknown. [18]

Additionally, the vaccine is genetically engineered yet the manufacturer admits it has not tested the vaccine for genotoxicity[17] (testing to see if the vaccine is toxic to our own human DNA).

Each dose of the vaccine contains 225 mcg of aluminum [6] which means girls receiving all 3 HPV doses will be directly injected with 675 mcg of aluminum.

In particular, the use of aluminum in the vaccine and placebo used in trials raised concern, since studies have linked aluminum to brain cell death and joint inflammation. About 60 percent of those participating in trials experienced headache, fever, nausea, dizziness, vomiting, or diarrhea, the NVIC reported. Among those who received Gardasil, more serious side effects included 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,” the statement said.
&n

bsp;
“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.
[21Feb07, LifeSiteNews.com, Gudrun Schultz]

QUESTIONABLE COST

The retail cost of the vaccine is $120 per dose, or $360 for the full series of 3 shots. [7] 

According to the bill’s author Sen. Leticia Van de Putte, there are 162,000 6th grade girls[19] which translates to forcing Texas families paying over $58 million dollars not including the doctor visits for a vaccine not proven to prevent cervical cancer. 

This is a high price to force families to pay especially for families skeptical of the necessity, efficacy, or safety of the vaccine. 

Merck is absolved from liability for the injuries and deaths caused by the HPV vaccine through the National Childhood Vaccine Injury Act of 1986 [20] leaving families to deal with the emotional and monetary costs of the harm caused by the vaccine to their daughters on their own.

The vaccine is available to anyone who wants it, so it does not need to be mandated. 

***

Doctor: QUESTIONABLE PURPOSE
The Gardasil’s product insert states their endpoint is the prevention of "High Grade Disease", this encompasses CIN II-III and adenocarcinoma in situ (AIS) which are "immediate and necessary precursors" for squamous cell and adenocarcinoma of the cervix.1 The MAXIMUM median follow up in any of their studies is FOUR years.

However, the time course from CIN III to invasive cancer averages between 8.1 to 12.6 years.2 Claiming this vaccine prevents cervical cancer, with the longest median study subject being 4 years, is inappropriate.

The study of the vaccine in children and adolescents is limited to only measuring the development of antibodies to the HPV subtypes in the vaccine. There is absolutely no evidence that the vaccine prevents anything when administered at this young age. Merck expects you to extrapolate their adult data to the immune response in children.

If they were really interested in vaccine efficacy in children, should it not be studied properly in children?

Vaccinating children for this or any other sexually transmitted infection is not without risk.

There are over 30,000 immunization reactions reported to the Vaccine Adverse Events Reporting System (VAERS) annually 8, and it has been estimated that only 10% or less of vaccine reactions are reported.9

In light of these facts the integrity of the post marketing surveillance of vaccines is questionable. Currently no vaccine has ever been examined for possible carcinogenic, mutagenic, or teratogenic effects, and yet the pharmaceutical industry stands ready to add Gardasil to the list of vaccines mandated for school admission.

Currently, precancerous lesions are readily identifiable and treatable in the developed world.

Cervical cancer causes approximately one percent of all cancer deaths in America.

The utility of this vaccine may be in third world countries in which regular screening is not available and cervical cancer is still a major cause of morbidity and mortality. The Committee Opinion states that there continues to be a significant population of women not receiving adequate screening.

If you estimate the cost of the series at $360.00 (the most expensive vaccine on the market) administered to all adolescent girls and use that money to expand and enhance screening, I believe the results might be quite impressive. To invest that amount of healthcare dollars in an immunization with no long term efficacy or safety data is unwise.

I have personally witnessed the devastation caused by severe vaccine reaction, including patients, their children, nurses and my own family. To proceed with mass vaccination against this embellished "threat" is premature.
Clayton Young, M.D., F.A.C.O.G., 2006
***

QUESTIONABLE MOTIVATION

While Merck’s behavior is probably adequately explained by the PROFIT MOTIVE [Gardasil grossed over $1.1 billion U.S. within nine months after hitting the market. By that time, Merck Frosst had distributed 13 million doses of the vaccine, which had been approved in 86 countries], what about those in the Health and Human Services bureaucracy who apparently see Gardasil as medicine’s gift to women?

What motivates them?

I (Mosher) think that they see Gardasil as what one might call a “wedge” drug. For them, the success of this public vaccination campaign has less to do with stopping cervical cancer than it does with opening the door to other vaccination campaigns for other sexually transmitted diseases, and perhaps even including pregnancy itself.

For if they can overcome the objections of parents and religious organizations to vaccinating prepubescent—and not sexually active—girls against one form of STD, then it will make it easier for them to embark on similar programs in the future.

After all, the proponents of sexual liberation are determined not to let mere disease—or even death—stand in the way of their pleasures. They believe that there must be technological solutions to the diseases that have arisen from their relentless promotion of promiscuity. After all, the alternative is too horrible to contemplate: They might have to learn to control their appetites. And they might have to teach abstinence.
[Joan Robinson is assistant editor for the Population Research Institute. By Joan Robinson and Steven Mosher; 26Oct09, ALL Pro-Life Today]
***

HARPER, LEAD RESEARCHER STATEMENTS
Diane M. Harper, a lead researcher in the development of the humanpapilloma virus vaccine, says giving the drug to 11-year-old girls "is a great big public health experiment."
According to Harper in 2007, the facts about the HPV vaccine are:

• It is not a cancer vaccine or cure. It is a prophylactic – preventative – vaccine for a virus that can cause cancer. "Merck has proven it has zero percent effectiveness for curing cancer," Harper said. "But it is a very, very good vaccine that prevents types of HPV responsible for half of the high-grade cervical lesions that cause about 70 percent of cervical cancers. For the U.S. what that means is the vaccine will prevent about half of high-grade precursors of cancer but half will still occur, so hundreds of thousands of women who a

re vaccinated with Gardasil and get yearly Pap testing will still get a high-grade dysplasia (cell abnormality)."

• It is not 100 percent effective against all HPVs. It is 100 percent effective against two types that cause 70 percent of cervical cancers.

• The vaccine only works if the woman/girl does not have a current vaccine type related infection (in other words, the vaccine only works when the woman/girl does not have HPV 6, 11, 16 or 18 – the viruses that Gardasil targets when she receives her first vaccine shot).

• The vaccine doesn't care if the girl/woman has been sexually active, Harper said. "HPV is a skin-to-skin infection. Although the only way to get cervical dysplasia is through an HPV infection, and HPV is most often associated with sexual activity, HPV is not just spread through sex. We have multiple papers where that's documented. We know that 3-year-olds, 5-year-olds, 10-year-olds, and women who have never had sex have been found to be positive for the cancer-causing HPV types."

• Therefore, for example, if a girl is positive for HPV 16 when she is inoculated with the vaccine at any age, she will not be protected against it later, Harper said. "That means it's a failure and those people are at risk for getting the HPV 16 and 18 cancers later."

• The only way to test for the presence of HPV is through a vaginal swab – which is inappropriate for young girls, she said.

• So what happens if the girls are vaccinated anyway, not knowing whether they were carrying the virus at the time of their inoculation? "They will not be protected if they were positive for the virus at the time they are vaccinated," Harper said.

• That is why it is important to note that the vaccine has not been tested for efficacy (effectiveness) in younger girls, she said. Instead, the effectiveness was "bridged" from the older girls to the younger ones – meaning that Merck assumed that because it proved effective in the older girls, it also would be effective in the younger ones. The actual tests on the younger girls, ages 9 to 15, were only for safety and immune response, Harper said, and then only as a shot by itself, or in combination with only one other vaccine, Hepatitis B. It has not been tested in conjunction with any other shots a girl receives at about age 11, Harper said.

• So far more than 40 cases of Guillian-Barre syndrome – a dangerous immune disorder that causes tingling, numbness and even paralysis of the muscles have been reported in girls who have received the HPV vaccine in combination with the meningitis vaccine. Scientists already know that sometimes a vaccine can trigger the syndrome in a subject. "With the HPV vaccine, it is a small number but higher than is expected, and we don't know if it's the combination of the two, or the meningitis alone," Harper said.

• In the end, inoculating young girls may backfire because it will give them a false sense of protection. And, for both young girls and women, because the vaccine's purpose has been so misinterpreted – and mis-marketed – Harper feels that too many girls and women who have had the vaccine will develop a false sense of security, believing they are immune to cancer when they are not, and failing to continue with their annual Pap exams, are crucial to diagnosing dysplasia before it can develop into cancer.

Keep getting pap smears
***

PARENTS NEED TO EVALUATE
Parents need to evaluate all aspects of the HPV vaccine since there are no long-term studies yet on the way these sixth graders might be affected in future years when it comes time for them to have their own babies. Also, since the vaccine has only followed girls for five years, nobody knows for sure how long the vaccination may last without having a booster.

The HPV vaccine covers 4 out of types of HPV (Types 6, 11,16,18) which account for 70% of cervical cancers and 90% of genital warts. That still leaves 30% of cervical cancers and 10% of genital warts which are not covered by the HPV vaccine.

Also, it will be important for the public to be continually reminded that there are many more sexually transmitted diseases than just HPV (e.g., chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, HIV/AIDS, etc.)

A definite drawback to Gardasil is that girls must get three full doses of the vaccine for it to be effective. How many families are going to understand the urgency of making sure their girls get three full doses over a six months' period of time? 

The seriousness of HPV has been one of the driving forces behind the plea for teens to remain abstinent until marriage. 

Condoms do NOT offer any kind of adequate protection against HPV since the virus is often carried/transmitted through skin to skin contact (on the parts of the body which are not covered by the condom).

It is important NOT to downplay the seriousness of HPV. Close to 90% of women who are infected with HPV will clear it; but according to the American Cancer Society webpage (Link: Cancer.org – How many women get cancer of the cervix=), "The American Cancer Society predicts that there will be about 11,150 new cases of invasive cervical cancer in the United States in 2007. About 3,670 women will die from this disease that same year." 
***

Certainly, no one wants to become a cervical cancer statistic; but so far, the statistics seem to show that girls and women experience a higher rate of adverse effects from the vaccine than from acquiring the cervical cancer.

 

Parents are urged to seriously consider all the vast amounts of information available regarding the HPV vaccines and decide if the benefits really outweigh the risks…
It is very hard to see that they do; but parents are entitled to make that final decision for their children…