Study provides further evidence to dispel HPV vaccine fears

Physicians have more research to help them reassure patients and families of the safety of the quadrivalent human papillomavirus vaccine. A study published online Oct. 1 in Archives of Pediatrics and Adolescent Medicine found no significant adverse events associated with the vaccine.

The findings should help alleviate concerns about the HPV vaccine, said Nicola Klein, MD, PhD, lead study author and research scientist and co-director of the Kaiser Permanente Vaccine Study Center in Oakland, Calif. The vaccine has faced controversy since it received Food and Drug Administration approval in 2006. Its vaccination rates have been lower than other vaccines, Dr. Klein said.

Thirty-five percent of girls 11 to 17 received all three recommended doses of the HPV vaccine in 2011, according to the Centers for Disease Control and Prevention’s latest data.

For the Archives study, researchers followed 189,629 girls and women 9 to 26 who received a total of 346,972 doses of the vaccine between 2006 and 2008 (link). They found that there was an increased risk of patients fainting at the time of the injection or developing a skin infection later. Those findings are in line with what was expected, Dr. Klein said.

“It’s a very reassuring study for both parents and health care providers,” she said.

HPV is the most commonly transmitted sexual infection and is associated with cancers of the cervix, vulva, penis, anus and oropharynx, the CDC says. About 20 million Americans are infected with one of the more than 40 types of the virus, and an estimated 6 million more are infected annually. Meanwhile, about 12,000 U.S. women are diagnosed with cervical cancer annually, the CDC says.

The CDC recommends three doses of the vaccine for preteen boys and girls at ages 11 and 12. It also is recommended for unvaccinated women through age 26 and unvaccinated men through age 21.

The side effects of fainting and skin infections are common with any vaccine, particularly among adolescents, said Harry Keyserling, MD, a professor of pediatrics at Emory University School of Medicine in Atlanta.

When a vaccine is licensed, there are multiple efforts to investigate potential adverse effects, he said. The CDC-sponsored Vaccine Safety Datalink monitors immunization safety. The Vaccine Adverse Event Reporting System — a joint initiative of the CDC and FDA — provides a place for patients and physicians to report adverse reactions to vaccinations.

“They are always looking at potential adverse effects,” Dr. Keyserling said.

Controversy about the HPV vaccine has centered around its safety and resistance from some parents and religious organizations to mandating the vaccine for adolescents. Dr. Keyserling is not sure whether the study will alleviate concerns of opponents of the vaccine.

“I can’t speculate on their motivations, but this [study] provides evidence to demonstrate that the vaccine has no significant safety concerns, and it is one of many studies that have come to this conclusion,” said Dr. Keyserling, a member of the American Academy of Pediatrics Committee on Infectious Diseases.