FDA Rejects Gardasil for Older Women
The pharmaceutical company, Merck & Co. Inc., won approval in 2006 from the US Food and Drug Administration (FDA) to market Gardasil, the first vaccine ever approved for the prevention of infection from human papillomavirus (HPV), which often causes cervical cancer. Gardasil is approved for use only in young females, those between the ages of 9 and 26.
Merck recently applied for FDA approval to use the vaccine on women aged 27 to 45 but the government agency denied approval of the vaccine for women in that age group, saying there are unresolved issues that prevent approval at this time. The FDA rejected Merck’s application for approval because they did not expect the unresolved issues to be addressed thoroughly within the time allocated for review.
A Merck official says the company expects to have a complete response to the FDA’s concerns ready in July.
The company is approaching the FDA’s current decision as a delay, not a final outcome, and is continuing with its plans to apply for approval to market Gardasil to men by the end of 2008. Men contract HPV and risk spreading it to their sexual partners. By vaccinating both males and females, the spread of the virus can be dramatically reduced.
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(Washington, DC) Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released a report based on new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reactions include 10 deaths since September, 2007. (The total number of death reports is at least 18 and as many as 20.) The FDA also produced 140 “serious” reports (27 of which were categorized as “life threatening”), 10 spontaneous abortions and six cases of Guillain-Barre Syndrome – all since January 2008. Adverse reports excerpts include:
• Information has been received…concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil….The patient died four days after…patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown. VAERS ID: 310262-1 (D)
• Information has been received…concerning a 23-year-old female…who on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil…the patient experienced anaphylactic shock 2 minutes after vaccination characterized by a brief loss of consciousness…respiratory arrest, eyes rolled upwards, blurred vision and greyish skin tone…Anaphylactic shock was considered to be immediately life-threatening. VAERS ID: 304739-1 (S)
• Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate post-injection reaction….Pt [patient, 14-year-old female] received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness. [Blood pressure] after seizure 60/40 pale clammy skin. [Patient] had bit her tongue and had foam around her mouth. VAERS ID: 305259-1 (S)
• Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a coma and is now paralyzed. At the time of this report, the patient’s outcome was unknown. VAERS ID: 303188-1
“Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” stated Judicial Watch President Tom Fitton.
Judicial Watch had previously obtained 3,461 reports relating to Gardasil. On June 10, 2008, Judicial Watch received a compact disk from the FDA with a new total of 8,864 Vaccine Adverse Event Reporting System (VAERS) records. These documents and the new Judicial Watch report, titled “Examining the FDA’s HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment,” are available at http://www.judicialwatch.org.
This is reprehensible that after all that has happened with Gardasil that it is still being hyped on t.v. and Texas is making it mandatory. Why hasn’t this information been more publicized before now? It seems that we cannot get the REAL news anymore. I am heartsick for the vulnerable little girls that have taken this drug and we don’t know what side effects are down the line. They are human guinea pigs for Merck. This is shameful and the greed involved is horrendous. Who manufactures the drug? Is it China? It’s all about the money and the young kids are collateral damage. Shame on this country.
FDA Rejects Gardasil for Older Women : MedHeadlines…
The approval of Gardasil for men, women, and children in the U.S. races through another curve on the fast track towards ending the spread of the S.T.D. Genital Warts and H.P.V….