Kaylyn Wright didn’t really have a choice. Her mom, Annette, made the appointments for Wright, Roeland Park sophomore, and her sister to be vaccinated against the sexually-transmitted disease Human Papillomavirus.

That was in 2006, just after the Food and Drug Administration approved Gardasil for use in women ages 9 to 26 to protect against HPV.

According to the Centers for Disease Control, the genital HPV infection is the most common sexually transmitted disease. About 20 million Americans have HPV, and another 6.2 million will become infected this year. While men can’t be tested for HPV, they are still affected by the virus through genital warts and can be transmitters of the infection.

To protect men against the virus, the FDA approved Gardasil earlier this month for use in men. Now Annette Wright has the choice to get her 16-year-old son, Brandon, immunized as well.

Getting the go ahead

Merck & Co., Inc., the manufacturer of Gardasil, has issued approximately 25 million dosages of the vaccine in the United States since 2006. Though the vaccine uses the same chemical formula for both men and women, it had only been approved for use in females.

Ali Kresge, global communications representative at Merck, said the company held trials for both sexes from the beginning but couldn’t receive approval at the same time.

“The FDA wanted more expansive clinical trials,” Kresge said. “They wanted to make sure that the data was comprehensive and strong.”

Lorrie McNeill, an FDA representative, said the multistep process for a drug to receive FDA approval started early in its development. Once the manufacturer can prove the drug works, it must submit a Biologic License Application to the FDA. If the application is for a drug that is intended to prevent a serious disease, it is marked “priority” and the FDA is required to review it within six months. All other drugs have a 10-month review period.

McNeill said because Gardasil was intended to prevent cervical cancer, the original application and the supplemental application for use in men were marked “priority.”

In September, the FDA’s Vaccines and Related Biological Products Advisory Committee recommended Gardasil’s approval for use in men.

“Our decisions are based on science and data,” McNeill said. “If a drug is proven safe and effective, we’ll approve it.”

The vaccine

Mai Hester, marketing coordinator at Watkins Health Center, said they planned to order additional dosages to accommodate males who wanted to be vaccinated.

Dr. Carolyn Johnson from Watkins Memorial Health Center said there were more than 40 types of HPV, but the vaccine only protected against the four most common types, which caused genital warts and vulva, vaginal and cervical cancers. She said the types that caused genital warts made up about 90 percent of the cases.

Kresge said the vaccine for both women and men was given in three dosages. The first one is given on a date chosen by the patient. Two months later the second dose is given. The final dose is given six months after the original date.

Hester said for uninsured students, each shot costs $148.50 plus a $12.50 injection fee at Watkins. For the entire vaccine, the cost is around $483. Hester said insurance coverage varied based on the individual.

“We are seeing more and more that insurances are covering it,” Hester said.

Kresge said the side effects and overall safety of the vaccine were the same regardless of gender. She said the most common side effect was soreness at the injection site. Headaches were also common among some patients. Fever, nausea, and dizziness can also occur.

The FDA had reports of fainting related to Gardasil injections, which is common with any vaccine given to adolescents.

Kaylyn said she did not notice any side effects when she received the vaccine and her family’s insurance covered the entire cost of the vaccine. She said if it hadn’t, she probably would not have gotten the vaccine because of the high cost.

Annette said Brandon would receive the vaccine if his doctors recommended it.

— Edited by Betsy Cutcliff