Parents of Daughters & Women Injured from Gardasil React to FDA Decision

FOR IMMEDIATE RELEASE
Winston Salem, North Carolina, United States of America (Free-Press-Release.com) April 20, 2011 -- Apr 19, 2011 – On April 7, 2011 the media broke the news about the U.S. FDA’s ruling against Merck's supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil use to an older population of women.

According to a report in MedPage Today, (visit http://www.medpagetoday.com/OBGYN/STDs/25776 for details)

“The decision was based on a trial in 3,253 women ages 27 to 45. Although the vaccine appeared to prevent persistent HPV infection, no significant benefit was found for more important outcomes such as high-grade neoplastic lesions or cervical cancer when all participants were included irrespective of baseline HPV status.”

Within days the news of the FDA’s decision traveled across the country and across the world. SANE Vax Inc. asked parents whose daughters have been injured by the vaccine – as well as victims themselves to comment on the decision.

Instead of protecting her life, it took her life.

I am thankful that the FDA did not give Merck a license to provide Gardasil for women over the age of 26 to 45 years. That is only one small step when in my opinion the FDA has made many errors with this program of vaccination. My 14 year old daughter died after having her second shot of Gardasil. She was in perfect health until she received this vaccination. We were told that we had to be responsible parents and that it was important that she have this vaccine. Instead of protecting her life, it took her life. The FDA still dares to suggest that this program is safe and effective and the benefits outweigh the risks. That is not true in my case or in the cases of all those who have lost their daughters, and even their sons, to this vaccine; and not forgetting the many thousands who have also been injured. There can never be a benefit when there is the death of a child.
Linda Morin, Quebec, Canada

I am very disappointed in the FDA and CDC in general regarding Gardasil and the monitoring of adverse reactions. The FDA recently rejected Merck’s 4th request to expand Gardasil use to women 26 years and older. I think this was a very good decision on their part, but the fact that they have left the vaccine on the market for females 25 and below is appalling. My 12 year old daughter was disabled by the Gardasil vaccine and missed almost an entire year of school. 2 ½ years later, she still suffers from the adverse effects of the vaccine. With over 20,000 adverse injuries reported and around 100 deaths, why is nothing being done to pull the vaccine from the market?

I have personally seen the damage the vaccine can do to a young, healthy girl. I feel it is justified to not allow the vaccine to be marketed for older women. I personally would never consider this vaccine for my 18 year old son or for myself as one who falls in the older age bracket. I wish I had known of the adverse effects and Gardasil prior to my daughter’s vaccine injury.

I would like the FDA to explain how Gardasil is acceptable in younger women when they say it has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. What is the difference? How can it be accepted as safe in the younger group but not in the older group?
Rosemary Mathis, North Carolina

Our daughters will never recover the years they have lost suffering the side effects of a vaccine that has been on the market without enough evidence of its efficacy. The governments around the world should do something to prevent these things from ever happening again.

Parents should be informed of the risks involved with this vaccine so they can make informed decisions about their daughter´s health. I wish I had known all the dangers this vaccine had before vaccinating my daughter - but the only information I received was (1) the vaccine protects women from getting cervical cancer - not true- and (2) the vaccine may only produce local effects such as pain or swelling on the site of the injection - not true either.

When my daughter was in hospital we wrote a press release to the International Scientist Community asking for help and the answer we received was that the only two cases of seizures in Spain and Europe were the Valencian girls; one is my daughter. We felt hopeless when we learned all the incidents of seizures reported to VAERS before February 2009 when my daughter received her second shot.

Now the FDA has rejected the use of Gardasil in women between 27-45 years old. In Spain, the vaccine is recommended for women older than 26. How can it be effective for women in one country – and not the other? How can this happen?
Alicia Capilla, Spain

Prior to my first injection of Gardasil, I had no health problems – that is not the case now. . A few weeks after my second injetion everything started to deteriorate. This led to paralysis and

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