FDA Advisory Panel Approves Gardasil Vaccine Against Cervical Cancer
Filed in archive Drugs, Vaccines and Therapeutics on May 20, 2006
The US FDA Vaccines and Related Biological Products Advisory Committee unanimously approved Gardasil®, Merck's recombinant vaccine against the human papilloma virus (HPV), a sexually-transmitted disease that can lead to cervical cancer in women.The committee also agreed that the data from Phase 2 and Phase 3 clinical trials prove Gardasil's safety and efficacy against other cervical, vulvar and vaginal lesions caused by HPV types 6, 11, 16 and 18 including genital warts. The vaccine got priority review earlier this year, and the full review will be completed by June 8, 2006. If approved (the FDA does not necessarily have to follow the advisory committee's recommendations), this will be the first and only vaccine to prevent cervical cancer, which afflicts approximately 10,000 women in the US annually, as well as other serious HPV-related diseases.
One thing that is not yet definite however, is how broadly the vaccine will be used. Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex. Merck also suggested using it in young boys, who cannot get cervical cancer, but play a role in controlling its prevalence.
On the business scene:
Some investors have been bidding up shares of MedImmune (nasdaq: MEDI - news - people ), the Gaithersburg, Md.-based maker of a drug for treating infections in premature infants, because the biotech has licensing agreements for key technology in the HPV vaccines of both Merck and GlaxoSmithKline, which is close behind with a similar preventative. Australia's CSL Limited, which is not traded in the U.S., may also receive a royalty.
Bernstein's Porges estimates that MedImmune could get $175 million in 2010 royalties from both vaccines, adding 46 cents to its earnings per share; that could be worth $7 to MedImmune shares, he says. Porges estimates 2010 worldwide sales of $3.3 billion for Gardasil, compared to $940 million for Glaxo's Cervarix.
Read more from Forbes, On Guard for Gardasil, and from Merck's press release.
[Photo: Institute of Human Virology]

Bernstein's Porges estimates that MedImmune could get $175 million in 2010 royalties from both vaccines, adding 46 cents to its earnings per share; that could be worth $7 to MedImmune shares, he says. Porges estimates 2010 worldwide sales of $3.3 billion for Gardasil, compared to $940 million for Glaxo's Cervarix.
Tags: vaccine cancer biotech cervical gardasil cervical+cancer vaccine+against advisory+panel
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Response from:
Jodi Speakman
(02/20/10 8:32am)
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My daughter has been seen by several neurologists, a psychiatrist, psychologist, several neuropsychologists, an immunologist, several infectious disease doctors, and also treated a at Wellness Center for a period of time. Wellness Center physicians believe that my daughter may have Lyme disease that was dormant until she was given the Gardasil vaccine. Infectious disease doctors differ. Which doctors are correct? I have no idea.
My daughter currently experiences the following symptoms: non-epileptic seizures, migraines, fainting, various tremors, twitches and numbness, intermittent leg paralysis and facial paralysis, tingling, staring or blank episodes, eye pain, joint pain, neck pain, back pain, memory loss, confusion, brain fog, regression, mood swings, hair loss and chronic fatigue. She continues to have bouts of nausea and diarrhea. She has not been in school since April 2008. My daughter can never be left home alone. She can't go to school, go out with her friends or work or has little "normalcy" in her life. She has very few good days and always says she doesn't feel good.
I do not know which way to turn for help. We have seen so many doctors and I can't seem to find anyone willing to help my daughter. There are so many other young girls who have the same exact symptoms as my daughter and the one thing that all of the girls seem to have in common is the Gardasil vaccination.
There are no "traditional medical doctors" who relate my daughter's symptoms to Gardasil as I am told "there is not enough information available" about the vaccine and doctors believe it to be "safe" . Most recently, a neurologist informed that he does believe that my daughter’s symptoms were brought on by the vaccine, just not in a way that he could test or prove.
The vaccine has been available for less than three years. Meanwhile, there are some doctors who are making the correlation between Gardasil and many of the girls' symptoms. However, the only doctors I know of right now are in California and Kansas. Other doctors are willing to "try" treatment, most of which is "homeopathic" in nature and extremely costly. Once again, I must reiterate that there are so many other young girls experiencing negative symptoms.
Each night, I check on my daughter many times in the middle of the night to make sure she is still breathing (like we ALL did when they were babies). I have increased security in my home in that I have a chime on her bedroom door so that each time she opens the door, I know she has walked out of her room. I had a deadbolt put on the front door of our home with a key that can be removed from the inside. I never leave the key in the door for fear that Victoria will be confused after a seizure or and leave our home. (This has happened several times and she has been missing). When she is in the shower, I have to either stand outside the door and/or keep asking her "are you okay?"
I often cry and wonder if Victoria will be next one to die from adverse reactions to Gardasil.
We are in desperate need of medical treatment for my daughter. I have run out of ideas, doctors to treat with and finances have dwindled. I do not know which direction to turn. Any thoughts are most appreciated, especially from the medical community.
The National Vaccine Information Center is in the process of circulating a petition to have Gardasil investigated by the government. There are more than 16,000 reported cases of adverse effects from the vaccine which have been reported to the NVIC (many of the adverse effects are extremely serious) and approximately 38 deaths have been reported.
Please feel free to forward this information.
Thank you for your time and attention.
Jodi Speakman
(267) 939-0591
Jodispeaks@aol.com
P.S. Victoria is one of five girls mentioned on the NVIC website. Victoria’s story appeared on the front page of the Philadelphia Weekly Newspaper in June 2009 and also mentioned on the front page of the Philadelphia Inquirer in August 2009. A Fox news story recently aired as well.