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Gardasil was approved in 2006, but the hyped vaccine does not benefit the appropriate population and has not been tested for long-term safety.
Merck’s Cervical Cancer Vaccine
On June 8, 2006 the FDA approved Gardasil, made by Merck and Co., as a vaccine for women aged 9-26 years to protect against cervical abnormalities caused by infection with HPV strains 6, 11, 16, and 18. The FDA clinical study summary states that Gardasil does not prevent HPV infection; it protects against the development of cervical cancer which has been shown to be caused by persistent HPV infection.
Gardasil Safety
Long term safety and efficacy studies have not been done on Gardasil. The FDA approved the vaccine based on short term benefits (24 months after the first injection) in women aged 16-26 and a study showing an immune effect in girls aged 9-15. Though the 90-100% efficacy seen in the short term studies is impressive, there have been no studies about the safety of using the vaccine in young girls and no studies of the effect on pregnancies that may occur within 30 days of receiving the vaccine, though it is advised that women thought to be pregnant should not receive the vaccine. However, in the FDA approval it was noted that Merck has promised the FDA that those studies will be done “post-marketing”.
The Cervical Cancer Vaccine
The vaccine contains purified viral proteins, called L1. They are non-infectious, but have been shown to activate the immune system in an identical manner to HPV infection. The proteins are injected with an adjuvant, a substance that helps speed the actions of the protein within the vaccine. In the case of Gardasil the adjuvant is an aluminum salt, despite a 2001 research study which found that the HPV-16 L1 protein is sufficient for an immune response and does not need an adjuvant.
In clinical trials more than three quarters of subjects receiving injections of just the aluminum adjuvant had adverse skin reactions; 83% of subjects receiving Gardasil had reactions at the injection site. Only about half of participants who received injections of plain saline had reactions at the injection site. This implicates a problem with the adjuvant solution. Though reactions at the injection site are normal for intramuscular vaccinations, the high rate and the development of reactions up to 5 days after the injections raises questions about the safety of the vaccine.
Gardasil Side Effects
It is no surprise then that there have been reports of fainting and dizziness in young girls who receive the vaccine. The clinical trials saw over half of participants receiving the vaccine experience headaches, nausea, and fever (an indicator of anaphylactic reactions when in the absence of infection) up to 15 days after the vaccination was received. Now that vaccinations have been given to a larger population there are more prevalent adverse reactions including deaths. A
ccording to LifeSiteNews.com in October 2007, the US Government's Vaccine Adverse Event Reporting System (VAERS) lists 3,779 adverse effects with 52 of the cases deemed "life threatening" and 119 requiring hospitalization. A review of some of the files pertaining to the deaths, obtained by Judicial Watch from the FDA via the Freedom of Information Act, points to a trend of young girls with heart conditions or unrecognized flu infections having cardiovascular or systemic autoimmune reactions to the vaccine. The FDA is lacking much of the important information surrounding the deaths and has been sued by Judicial Watch for not being forthcoming with the information. The adverse side effects reported by many media outlets in the United States as well as the UK include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures in otherwise healthy girls.
The Cost of Gardasil
The series of 3 shots costs, on average, $360 per girl and would be a huge profit for Merck since Gardasil is the only vaccine available for cervical cancer or HPV infection. In November 2007, Merck announced to stockholders that they are seeking FDA approval to vaccinate women up to age 45, despite clinical studies cutting off the ages of interest at 26. As stated by the BloggingStocks website, “[E]xpanding the market to older women could take the focus off that issue [of young girls receiving the vaccine] as well as increase Merck's market at the same time.”
Merck had also funded a legislative push to make the vaccine mandatory for school aged girls, spending a reported $250,000 in Texas, the first state to mandate vaccination. Merck backed off the legislative push in other states when reports of deaths began to surface and parent groups spoke up against mandated vaccination. The American College of Pediatricians has called for long term studies of efficacy and side effects before making the step forward.
References
- Kjaer, S.K. et al., 2002. Type specific persistence of high risk human papillomavirus (HPV) as indicator of high grade cervical squamous intraepithelial lesions in young women: population based prospective follow up study. BMJ (Clinical research ed.), 325(7364), p.572.
- Cuschieri, K.S. et al., 2005. Persistent high risk HPV infection associated with development of cervical neoplasia in a prospective population study. Journal of clinical pathology, 58(9), p.946-50.
The copyright of the article Cervical Cancer And Gardasil in Vaccinations is owned by Alicia Mae Prater. Permission to republish Cervical Cancer And Gardasil in print or online must be granted by the author in writing.
Comments
Sep 6, 2008 3:01 PM
Guest :
Possible side-affect: Seizure?
About 7 months ago and in order
to attend the high school I was required to get a physical exam. Of
course, the doctor STRONGLY recommended the Gardasil shot. I refused to
take it because it was so new, I was afraid of the possible long-term
affects that were still unknown. I have had three other doctor
appointments since then, and all recommended the shot, despite that I am
not sexually active. None of the doctors could give me straight answers to
any of my questions.
Earlier today I had my first
Gynecologist appointment. When I asked her the same questions as the other
doctors I got some clarification.
Me- "I’m am not sure about it
because they do not know the long term affects."
Doc - " it
has been tested for a very long time and in fact i gave it to my three
girls"
Me-"Are there any known side-affects or possibility
of anything being passed on to future children"
Doc- "No.
Not at all, beside pain in the arm."
With the ominous
cancer threat, a possible prevention, and the security of her words, I was
won over.
About 3 seconds after my shot, I passed out and had
a mild seizure.
It was the worst and scariest experience of my
life.
About an hour later, still dizzy, Nauseated and
traumatized, two doctors came to visit my mom and I and started talking as
if I simply passed out, due to shot anxiety...I do not have shot anxiety.
EVEN THOUGH, my mother had overheard a nurse in the hallway say "the
girl had a mild seizure, that’s the second one with that shot."
I was talking to a woman after I had semi-recovered, and she
explained how this was happening to girls all over the country, some even
becoming paralyzed...
WORST DAY OF MY LIFE.
I
want other girls to know, how can I get the word out?
D.
16
yrs.
Sep 6, 2008 3:09 PM
Alicia Mae Prater :
That's a tremendous story and I thank you for sharing it.
What
you can do to get the word out? Tell everyone your story, post it, blog it,
embrace it as your experience and don't back down about what you
experienced.
The truth is that the vaccine has NOT been tested
long-term, as 5 years is not long-term for a disease that can take 20 years
to develop. The doctor that told you it has been and that there are no side
effects should be told your story. She obviously does not know all the
facts.
May 8, 2009 3:08 PM
Guest :
My daughter had the series of 3 injections, the last one was given in 2008
(summer of last year). We didn't observe anything alarming other than
tenderness and soreness at the injection site. Early this year, starting
Feb 2009, our daughter became nausiated and threw up several times. We
checked and she did not have a fever. The nausia lasted about a week and
she missed 2 days of school... no big deal. Since then she has had 3 other
bouts of this condition. Up until now she has not missed a single day of
school, ever. She has been very healthy other than thsi unexplained nausia,
weakness and vomiting about every 4 to 6 weeks appart. This has not been
explained by our doctor but I wanted to post this and see if others are
experiencing the same problems.
Aug 26, 2009 9:25 AM
Guest :
My daughter received 2 of the 3 doses about a year ago when she was 13.
Since the second shot, she developed migraines. They have worsened over
time. She went for an MRI and they found white matter lesions on the
frontal lobe of her brain. I did not take her for the third dose. I can't
help but wonder if the shot was the cause of this. She has never had
headaches prior to this. She is currently under the care of a pediatric
neurologist and they cant even decide what the cause of her troubles are.
Has anyone else had similar problems?
Sep 3, 2009 7:44 PM
Guest :
looks like i will be home schooling my kids if this is now required for
attendance in public schools.
Sep 3, 2009 7:50 PM
Alicia Mae Prater :
It's not currently mandatory in most states, and if it is in your state you
can get an exemption for philosophical or religious reasons
http://www.unhinderedliving.com/statevaccexemp.html
Oct 1, 2009 5:12 PM
Guest :
I worry that people simply googling about the HPV vaccine will see so many
negative comments regarding the vaccine and panic. Simply put, people are
more likely to describe negative experiences than positive ones. For every
"horror" story regarding the Gardasil and any
vaccination/medication, there's going to be hundreds or thousands of
positive ones that don't get told. As for all the stories saying, "I
got the shot(s) and some time later I developed this horrible and
debilitating disease!", I can only be critical. There's absolutely no
proof that a vaccine caused such-and-such medical issue. As a research
scientist (and no, not a pharmacological researcher), I'm disappointed that
the ignorance of a few spread and influence the opinions of many. A little
scientific education can go a long way.
Oct 1, 2009 6:12 PM
Alicia Mae Prater :
For anyone interested, here is the Adverse Event Reporting Database of the
FDA
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillan
ce/AdverseDrugEffects/default.htm
Most of the adverse events
considered life-threatening have not been definitively linked to the
vaccine over the past almost 2 years. Further studies on the vaccine are
still ongoing.
Oct 21, 2009 8:32 AM
Guest :
My daughter is having adverse effects from the first of the series of 3
shots. Without going into detail, her info. was reported to VAERS after
the last reports to come out by the Freedom of Information Act reported by
Judicial Watch. It is critical that parents have their doctor fill out the
VAERS report and follow up to make sure that it is done. Much of the info.
reported to VAERS is incomplete. All info. should be put into the reports.
The report will show a temporary VAERS no. Have your info. and especially
that no. so you can follow up with further info. Without doing so, Merck
and I imagine GSK, will continue their big push of deception in the public
school system. My daughter, a senoir in hs brought home a permission slip
to leave school so she could attend a meeting about college and being on
your own. The agenda was clear, push girls to get vaccinated with Gardasil
by telling them it is their responsibility to take control of their
lives-along with the visual pictures of std's and thoughts of getting
cancer. The male students apparently had a separate meeting. The FDA has
now approved Gardasil for boys. You can go to UPI.com to read the article,
"Medical groups paid for vaccine promotion."
9 Comments
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Jan 16, 2008
