Although HPV vaccination is approved for males as well as females, it has been routinely recommended only for girls and women up to age 26. The ACIP decision changes that.
The panel voted 13-0, with one abstention, to make HPV vaccination with Gardasil routine for boys aged 11-12. In a second 8-5-1 vote, the panel extended routine Gardasil vaccination to boys and men through age 21.
And in a third vote, the panel voted 13-0-1 to recommend Gardasil for 22- to 26-year-old men who have sex with men, or who have weakened immune systems. Boys 11-12 years old will be offered Gardasil as a routine vaccination; it can be given as early as age 9. It will be offered as a catch-up vaccination to older teens and young men who have not completed the three-shot series.
The ACIP continues to recommend either of the two HPV vaccines, Merck's Gardasil or GlaxoSmithKline's Cervarix, to women. It's routinely recommended at age 11-12 and may be given as early as age 9, with catch-up vaccinations up to age 26. Cervarix is not approved for men.
Gardasil's cost -- listed on a commercial Internet pharmacy site at about $140 a dose -- made some of the ACIP panel members hesitate to recommend it for young men. But many were swayed by an argument from James Turner, MD, executive director of the American College Health Association and a professor at the University of Virginia.
Turner noted that while most of the panel focused on the cancer-prevention benefit of HPV vaccination, the vaccine offers other less tangible benefits. A strong recommendation, he said, would ensure that the vaccine is covered by health insurance.
"The consequences of HPV rarely include cancer but always include anxiety, suspicion about a partner's fidelity, or about being 'damaged goods' and never able to enter into a valid relationship," Turner told the panel. "By making a firm recommendation, we remove any ambiguity about insurance covering this vaccine."
By the Numbers
HPV -- human papillomavirus -- causes cervical cancer in women. It also causes genital warts, anal cancer, and oral cancer in both sexes, as well as penile cancer in men. Men who have sex with other men are most at risk of anal cancer caused by HPV and are the men who may most benefit from Gardasil vaccination.
If at least 50% of women got all three doses of HPV vaccine, heterosexual men would largely be protected from the virus. But even though HPV vaccine is routinely recommended for girls, only 32% have completed the three-dose series.
Vaccinating males will not be cheap. The CDC estimates that the first-year cost will be:
- $136 million for boys aged 11-12, assuming 11% of boys start the vaccination series and 70% of them get all three shots.
- $661 million for teens aged 13-18, assuming 17% start the vaccine series and 70% finish it.
- $62 million for men aged 19-21, assuming 3.2% start the series and 55% finish it.
To reinforce that point, William Schaffner, MD, president of the National Foundation for Infectious Diseases, asked a pointed question.
"In view of recent political discussions, are there any indications of central nervous system dysfunction or mental retardation associated with this vaccine?" asked Schaffner, chair of preventive medicine at Vanderbilt University.
"There is no evidence," said Eileen Dunne, MD, MPH, who presented the CDC's report on Gardasil safety to the ACIP.
As with other vaccines, HPV vaccination sometimes is associated with fainting episodes. Fainting after vaccination usually happens within 15 minutes of getting a shot. It's more common in women than in men.
HPV vaccination has rarely been linked to skin infections, such as abscesses or cellulitis, near the injection site. There have been 12 reports of severe allergic reactions to Gardasil. All of these patients recovered.