The Gardasil vaccine is still in its infancy after its public debut in June 2006. Yet, despite that short amount of time, several points of controversy and a handful of unpleasant side effects have hit the public and people want an explanation, now.
The vaccine, produced in a competition-free market by Merck & Co. Inc., is the only one of its kind thus far. Its purpose is to protect women against diseases caused by four types of the Human Papillomavirus (HPV) and is administered to women between ages nine and 26.
Some of these diseases include cervical or vulvar cancer and genital warts.
The side effects as listed in the patient product information release range from headache, dizziness and fainting to hives or a rash, to chills, stomachaches and seizures. Anaphylaxis, which is a fatal allergic reaction, has also been reported.
This leads to reports of deaths caused by the vaccine. According to the prescribing information, reviewing the clinical trials, there were 24 deaths reported in the 25,274 subjects (only 13, 686 actually received the vaccine; the others received a placebo).
According to the Centers for Disease Control and Prevention, a total of 27 deaths have been reported between June 2006 and August 2008 in the United States. The reports were not directly attributed to the Gardasil vaccine, but all women had received it prior to their deaths. Some of the deaths were linked to blood clots, seizures and heart failure, which are side effects of the vaccine.
The CDC also reported that Guillain-Barre Syndrome (GBS), a disorder that causes muscle weakness, has resulted from the vaccine.
The CDC and the Food and Drug Administration encourage users to report all side effects to the Vaccine Adverse Event Reporting System (VAERS) and as of June 30, 2008, the FDA had received 9,749 “adverse events” reports after the injection of Gardasil.
The CDC sent CBS News an e-mail listing important points after CBS broadcast a story about an 18-year old woman who received the vaccine and developed a serious reaction that led to myofasciitis, a painful autoimmune disorder.
“We are surprised by the number and type of reported adverse event cases following Gardasil,” the FDA stated in the memo. “Most adverse events (94 percent) reported to VAERS for Gardasil were not serious.”
Part of the controversy is in choosing to receive the vaccine. Not everyone has a choice or fully understands the vaccine.
Gardasil has now become a requirement for all female immigrants ages 11 to 26. This ruling went into effect in August 2008, and more than 130,000 immigrants will be affected.
The younger female population of the United States receives the vaccine based on parental discretion. Most nine-year-olds have never heard of HPV.
Men are also susceptible to contracting and spreading HPV, but there is no licensed vaccine for them. The FDA is currently considering approval so long as Gardasil is safe and effective for men.
According to research and testing done on all other approved vaccines, the research and time spent on Gardasil is no different.
“I don’t think there’s any cause for alarm, whatsoever,” said Dr. Daron Ferris, a member of the Gardasil research team. “Tens of thousands of patients were studied for as long as five years.”
The other points of controversy lie in necessity and safety. Some parents do not see reason to administer a vaccine for a sexually transmitted disease to their children. Another point is the duration of the vaccine. At this time, no one knows how long Garadsil’s protection lasts.
The vaccine is administered in three doses, the final dose occurring six months after the first. Missing a dose or not completing the sequence will not harm the patient, but she will not receive the full benefits of the vaccine.
If you have received the Gardasil vaccine or are considering it, visit www.gardasil.com to learn more and make an educated decision. Also, visit the College Living page of newsrecord.org to comment on your experiences with Gardasil.
The News Record > Sections > College Living
Gardasil Side Effects, Controversy
Published: Sunday, February 8, 2009
Updated: Friday, November 20, 2009





data manipulation,deception. This is a horrific tragedy. CDC and FDA paid by Merck, represent Merck interest. The
VAERS database was not even updated in the last two month. God help us all.
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