Unlike the U.S., where for some unfathomable reason some people still fight tooth and nail against vaccines, Australia has had a nationwide program to vaccinate females in that age group since April 2007.
There were 35 reports of suspected hypersensitivity, but only reactions from three of the 25 patients that agreed to skin-prick and injection (to confirm reactions) were likely tied to the vaccine.
The blurb on the BMJ site says:
Allergy and immunology consultant Liew Woei Kang and colleagues evaluated suspected hypersensitivity in adolescent girls immunized with a human papillomavirus vaccine in Australian schools. They found that true hypersensitivity to the quadrivalent human papillomavirus vaccine was uncommon, and most girls tolerated subsequent doses.The authors say that their data suggest that "true hypersensitivity to the quadrivalent vaccine is uncommon and that suspected hypersensitivity reactions such as urticaria are often idiosyncratic and not usually a contraindication to further vaccinations. Studies of other vaccines have found that most reactions after immunisation are not due to hypersensitivity and revaccination is usually well tolerated."
In an LA Times article on the study, reporter Mary Engel notes:
In the U.S., the Centers for Disease Control and Prevention recommends Gardasil be part of routine vaccinations for girls ages 11 and 12. The vaccine is most effective if given before young women become sexually active and possibly exposed to the virus.More than 10.000 adverse reports?? That's a lot. I wonder how many of those are confirmed to be associated with the vaccine. [Of course, if there is an actual reaction, then yes, it should be noted and included in the vaccine's label.] What I'm most excited about is a follow-up on the females that were vaccinated to see how the rates of cervical cancer are affected.
About a quarter of U.S. teen girls -- roughly 2.5 million -- received at least one of the three-shot series in the vaccine's first full year of distribution, according to the CDC. The goal is 90%. Only Virginia has made Gardasil mandatory.
The FDA has received more than 10,000 "adverse events" reports from physicians and patients after Gardasil injections.
Most involved pain at the injection site, headaches, nausea, fainting or fever. The 6% of incidents that were deemed serious included almost 30 deaths as well blood clots and several cases of Guillain-Barre syndrome, an autoimmune disease that can lead to paralysis. The FDA says there is no evidence that Gardasil caused the deaths or led to Guillain-Barre.