The HPV vaccine is the stuff of debate, and by that we mean there are parents who feel great about marching their sons and daughters to the doctor to get the shots, and there are parents who would rather put their kids in a canoe without a life preserver than have them vaccinated.
Their reluctance is often tied to doubts about the vaccine’s safety. On the Web site Truth About Gardasil (which makes one of the HPV vaccines), information on the home page states that “thousands of girls are having adverse reactions to the HPV Vaccines, some have even died.” Among those adverse reaction claims are seizures, strokes, fatigue, stomach pains, insomnia and rashes.
A study released today may or may not quell some of those fears. An independent safety committee looked at side effects soon after vaccination among 189,629 women who got one or more doses of the quadrivalent human papillomavirus vaccine between 2006 and 2008.
The only side effects associated with the vaccine were a higher incidence of fainting soon after being given the shot, and skin infections within two weeks of the shot.
A couple of things to note about the study: it was funded by Merck & Co., which manufactures Gardasil, and the study was done as a postlicensure commitment.
Those are often required by the Food and Drug Administration and the European Medicines Agency after a drug is approved as a condition to allow the pharmaceutical company to continue to market its medication.
The FDA approved the quadrivalent vaccine in 2006 for girls and women age 9 to 26 to protect against diseases such as cervical cancer. Gardasil was approved in 2009 for boys and men to guard against genital warts and certain types of cancer. The Centers for Disease Control and Prevention recommend the vaccine for males and females.
During the course of the study there were 14 deaths, but none were attributed to the vaccine. Causes included lymphoma, drug overdose, lupus and pneumonia. No links were seen between the vaccine and hospitalizations or emergency room visits due to autoimmune disorders.
One caveat: the authors acknowledged that the study only looked at conditions that came on within two months of getting the vaccine and didn’t examine at long-term effects. “On-going monitoring of spontaneous reports and other sources such as the Vaccine Safety Datalink,” they wrote, “will further contribute to the HPV4’s safety profile.”
The study was released online today in the Archives of Pediatrics & Adolescent Medicine.
Have you opted to get your children the HPV vaccine? Let us know in the comments.