Child Health Safety
Posted on April 20, 2011 by childhealthsafety
SANEVax News Release
Parents of Daughters & Women Injured from Gardasil
React to FDA Decision
Why are medical consumers the medical experiments?
Safety and efficacy studies should be conducted for all intended age intended before market release.
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
‘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
With over 20,000 adverse injuries reported and around 100 deaths, why is nothing being done to pull the vaccine from the market?
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