A vaccine against human papillomavirus, commonly known as HPV, a virus known to cause genital warts and cervical cancer, is safe, according to a study of almost 200,000 girls who received the vaccine.
Concerns over the safety of the Gardasil vaccine emerged shortly after the Food and Drug Administration approved it in 2006, despite the Centers for Disease Control and Prevention, the American Academy of Pediatrics and the American Academy of Family Physicians all deeming the vaccine safe and recommending it be given to girls ages 11 and 12.
Dr. Nicola Klein, pediatrician and lead author of the study published Monday in the Archives of Pediatrics & Adolescent Medicine, says she hopes the study puts those rumors to rest.
"All parents should feel assured this was a very comprehensive study and that the vaccine is safe for use," said Klein, of the Kaiser Permanente Vaccine Study Center in Oakland, California.
The HPV vaccine is administered in three doses over the course of six months. Researchers looked at emergency room records and hospital visits for 60 days after each dose given to the 189,629 females in the study.
The only side effects associated with the HPV vaccine were same-day fainting and skin infection around the injection side, according to the study.
Merck & Co., the makers of Gardasil, funded the research and worked in collaboration with the Kaiser study team. While it is common for the FDA to request or require post-marketing safety studies, the researchers say an independent safety review committee - made up of experts from the Mayo Clinic and Johns Hopkins University, among others - reviewed all final data and results.
HPV is the most common sexually transmitted infection. At least 50% of women and men will acquire it at some point in their lives. The virus itself is the leading cause of cervical cancer in women, and can also lead to other health problems like mouth cancer and genital warts.
The vast majority of infected people will never have symptoms, and continue to pass along the disease to their partners. Previous research published in the Journal of the American Medical Association found the virus is most prevalent in people right after they start having sex."In order to for the vaccine to combat to virus as designed, it is very important to vaccinate girls prior to them being sexually active," said Klein.
The FDA has approved two HPV vaccines - Cervarix and Gardasil - for use in females ages 9 to 26 years old. Earlier this year, the CDC and American Academy of Pediatrics recommended that boys also get the HPV vaccine.