FDA approves Cervarix human papilloma vaccine as cervical cancer deterrent [Updated]
The Food and Drug Administration today approved Cervarix, the vaccine against human papilloma virus (HPV) manufactured by GlaxoSmithKline, for use in girls and young women ages 10 to 25. An FDA adivsory panel recommended approval of the vaccine on Sept. 9 and the agency followed the group's recommendation. The vaccine joins Gardasil, which was introduced in 2006. Glaxo had applied for approval about the same time, but consideration of the vaccine was delayed because of concerns -- since discounted -- about potential adverse reactions.
[Updated at 10:32 a.m.: The agency today also approved the use of Gardasil, manufactured by Merck & Co., for boys and men ages 9 to 26 for the prevention of genital warts. The advisory panel had also recommended such approval in September.]
Both vaccines protect against two of the 15 strains of HPV that cause cervical cancer: types 16 and 18. They have been shown to be more than 90% effective in preventing tumors caused by those strains, which account for about 70% of all cervical cancer cases. Gardasil also protects against two other strains of HPV, types 6 and 11, associated with genital warts, which are sometimes precursors of anal and penile cancer.
About 20 million Americans are infected by HPV each year. Most infections are cleared by the body, but the virus is thought to be responsible for an estimated 11,000 cases of cervical cancer each year, with 4,000 deaths. In men, the virus has been linked to anal cancer, which strikes about 2,000 men per year, and penile cancer, which is even rarer.
Gardasil has been controversial. Some religious critics argue that it seems to give young girls a license to engage in sexual intercourse. Other critics believe it has been linked to many adverse events, although the advisory panel discounted such claims. The vaccine is also quite expensive, about $400 for the recommended panel of injections.
-- Thomas H. Maugh II
Sadly the women who get cervical cancer (usually in their 50's or later) are not the same women who get regular gyn care or pap smears so we are essentially giving a vacine to young girls who aren't in the high risk pool of women who will get cervical cancer 30 some years later.
It is similar to looking for your keys under the streetling because the light is better there.
The drug companies have also gotten many states to require the vaccine so it is exempt from any lawsuits. No one knows if the vaccine lasts for more then a few years and the vast majority of women clear the HPV infection on their own and will never be at risk for cervical cancer. Instead of spending all of this money on an untested vaccine we should instead ensure that all women receive adequate pre-natal care, sex education and gyn services
Posted by: Dr Jennifer Bolen | October 16, 2009 at 09:17 AM
Now we will have fun fun fun...watching the little boys become paralysed to. I can't believe that the FDA had the gull to make it legal for them to poison the little boys. Wasn't it enough to damage our girls. My daughter has been ill since she received her gardasil shots. Look out for your boys and do your research. Big Pharma just wants to make money. My daughters symptoms are peripheral neuropathy both feet, peripheral vision loss left eye. Migraines with intermittant paralysis, mini strokes, bloody stools, bloody noses, brain fog. Constant fatigue, way to go FDA and CDC. I hope you all go get your gardahell shots and become cripples.
Posted by: karenahaack | October 16, 2009 at 12:44 PM
Cervarix is built upon a relatively new adjuvant which consists of a bacterial endotoxin derivative, called monophosphoryl lipid A, that awakens the immune system based on pathogen mimicry. In doing so, it elicits a robust immune response to the vaccine with the hope that lasting protection is rendered against HPV.
However, we may want to pay close attention or take a broader view that these types of adjuvants may reach beyond their intended purpose as a mere vaccine enhancing agent. For example, pre-clinical studies have shown that antibodies can be generated against monophosphoryl lipid A which may cross react with other lipids.
So before giving yourself a boost with this new generation vaccine, in particular, Cervarix -- and other GSK vaccines that use this adjuvant -- the informed health provider, parents and daughters may want to understand what anti-lipid antibodies are elevated, if any.
Based on the basic science literature, it is reasonable to assume that GSK and the FDA have already asked whether anti-lipid antibodies are generated in their clinical trial patients. Or at least, we hope so. And if so, what are the implications with elevated anti-lipid antibodies?
Posted by: SJ Green, PhD | October 16, 2009 at 01:00 PM
This is a sad day for all the Gardasil injured girls!
My daughter is one of them.
She had 2 of the 3 injections (Jan 9th and March 9th, 2009). Before Gardasil, she was a happy, healthy and vibrant teenager. Since Gardasil she is sick every day of her life. She has dizziness, overall weakness, numbness and tingling in both legs and left arm, back pain, neck pain, pressure headaches, vision problems, breathing problems, chest pains, racing heartbeats, brain fog, stomach problems, nausea, diarhea, weight loss, hair loss, jerking all over spells...the list goes on and on.
She was an A/B student but failed her 10th grade year because she was too sick to retain what she was trying to learn (brain fog). She no longer has the energy to go off with her friends. Most days she lays in bed, in pain.
This just doesnt happen to a healthy teenager!! And it just doesnt happen to THOUSANDS of other girls with no connection except they all had the Gardasil vaccine.
It doesnt take a rocket scientist to figure this one out.
Please educate yourself as much as you can before you allow anyone to push this unproven and unsafe vaccine on your daughter! The guilt is overwhelming from a mothers' standpoint! I thought I was doing something to protect my daughter. Instead, I allowed the doctor to inject poison into my child and take away her life!
These 'side effects' are NOT rare! They are happening every day to literally hundreds of thousands of young girls after receiving Gardasil. The numbers in VAERS is estimated to only be between 1-10% of the true numbers! Try asking some of us moms who have to deal with these horrible side effects every day if we consider it to be RARE!
Everyone should look at the other side of the fence and research this. There are thousands of girls that are coming down with strange illnesses, paralysis, gran mal seizures, etc. after receiving Gardasil.
We are now getting reports of girls as young as age 9 that are breaking out with genital warts and severe cases of cervical cancer AFTER receiving Gardasil. Some of these girls/women did not initially have any side effects from the vaccine.
There are perfectly healthy girls all of a sudden come down with all of these strange sicknesses (some that I cant even pronounce) after getting jabbed with Gardasil. All within hours/days/weeks?
Just like Merck's 'wonderful' Vioxx...what will it take? How many dead/injured before someone takes notice?
The doctor that literally pushed this vaccine on us at a routine doctor visit told us that there were no side effects except for soreness or redness at injection site.
She also told us that it would protect her from a whole LIST of things! I had seen the commercials but had not researched it.
As a matter of fact, I never really THOUGHT about vaccines until my daughter suddenly started having all of these strange health issues.
She was ALWAYS a healthy child, happy and outgoing, active and just a joy to be around.
Now, she is a totally different child. She is always sick..always in pain..and cries a LOT, so scared that she will die in her sleep from the breathing problems. She describes it as breathing through a blanket or that an elephant is sitting on her chest.
She has SO many of the exact same symptoms as all of the other girls that have been injured.
It is NOT a coincidence! All of these Gardasil girls have the same symptoms, some worse than others, but the bottom line is the one thing they all have in common is Gardasil.
These symptoms are NOT in their heads!
My daughter started having dizziness, overall weakness, pain and numbness in both legs and left arm BEFORE we found out about any of these other girls having the same issues.
When I called her doctor that gave her the vaccine (as soon as she started with these symptoms) she said it was NOT the Gardasil vaccine that is causing it. How could she be so sure? This is such a NEW vaccine...a DANGEROUS and UNNECESSARY vaccine!
HPV is not an STD (research this!)
How can they just dismiss all of these girls getting the SAME symptoms after receiving Gardasil or Cervarix? It just doesnt make sense!
Cervical cancers have gone down 70% since the PAP smear came along.
This is NOT an epidemic! Why are they mandating this vaccine for as young as 9 year old girls for a vaccine that doesnt even do what they claim it will do?
Girls are now coming down with cervical lesions and HPV AFTER receiving Gardasil! I'm talking about healthy young girls that did NOT have these things BEFORE getting Gardasil.
Young girls dropping dead within hours of getting the vaccine and they think we are all stupid enough to believe it was a huge tumor that was in her heart and had spread to her lungs? (I'm speaking of the 14 yr old that just recently died after receiving Cervarix).
If that young and healthy and active young girl really DID have this so called huge tumor, she would have had symptoms. A tumor like that doesnt just up and kill it's host without a 'wasting away and painful period'.
That is a complete cover-up!
Just like the young girl that has been paralyzed and hospitalized for the last year, Ashleigh Cave. Because her mother was trying to speak out and find out what exactly happened to her daughter, they have now placed that child under protective orders! To shut the mother up?
This is all about $$$$$ at the expense of our young daughters (and now sons) health and lives!
It is an outrage!!!
Please see my posts at www.injuryboard.com/Teresa-Allen
And this website:
http://wbx.me/l/?u=http://lecafpolitiquedecamusdecaf.blogspot.com/2009/09/gardasil-and-how-it-has-affected-lives_14.html
There, you can see other girls' stories and their pictures..there is also a memorial document with pictures and stories of young girls that have died after receiving Gardasil.
Educate Before You Vaccinate!!
Posted by: Teresa Allen | October 16, 2009 at 01:34 PM