The Advisory Committee on Immunization Practices (ACIP) has recommended that boys aged 11 to 12 years should receive the human papilloma virus (HPV) vaccine to prevent genital warts and several types of cancer.
The new recommendation, delivered to the Centers for Disease Control and Prevention (CDC), states that the three-dose quadrivalent vaccine (Gardasil, Merck) schedule can begin as early as age 9. Unvaccinated boys and men between the ages of 13 and 21 also were included in the ACIP statement.
“It is truly exciting to have vaccines that can also tackle cancers. The idea that we could prevent cancer with the vaccine really motivated much of ACIP’s thinking [in making this recommendation],” said Anne Schuchat, MD, director, National Center for Immunization and Respiratory Diseases, during a CDC press briefing.
In 2006, the ACIP recommended the HPV vaccine for girls and women aged 11 to 26 years because of the increased risk for cancers of the cervix, vulva, vagina, anus and several forms of oral cancer. However, immunization rates among girls and women have increased modestly since 2006.
“There’s been a disappointing uptake among teen girls. HPV vaccination of males offers an opportunity to decrease the burden of HPV-related disease in both males and females,” Dr. Schuchat said.
Once the CDC approves the ACIP recommendation, it will encourage private insurers to cover the cost of the three-dose quadrivalent HPV vaccine (usually $130 per dose) without a copay. The HPV vaccine has been covered for Medicare-eligible teenagers since 2009 and costs $108 per dose in the public sector.
Although immunizing boys against HPV will lower their risk for oral and anal cancers, there is an additional benefit derived from this strategy. By preventing the transmission of HPV from males to females, the incidence of cervical cancer caused by HPV will decrease.
These new recommendations undoubtedly will enhance the debate over whether children need to be immunized against a sexually transmitted infection (STI). Opponents question why this population needs to be protected from an STI because they believe that children should not be sexually active.
“Antibody or immune responses are the strongest [at age 11 or 12] and that is well before girls and boys would become sexually active. So the vaccine works best when given at the younger age,” said Dr. Schuchat.
There also is some concern about the safety of Gardasil. The CDC has confirmed 34 death reports to its Vaccine Adverse Event Reporting System following vaccination with Gardasil. However, Dr. Schuchat noted that, currently, the ACIP does not believe there is any evidence to support severe life-threatening outcomes associated with Gardasil.
The most commonly reported adverse events for Gardasil, which range from mild to moderate intensity, are injection-site pain, headache and fever.
Currently, two FDA-approved HPV vaccines are available to girls and women: Gardasil and a bivalent vaccine (Cerevix, GlaxoSmithKline). Gardasil is the only HPV vaccine approved for use in boys and men.
More than 80% of anal cancers are caused by strains of HPV that the current vaccine protects against. It also prevents the most common strains that cause cervical cancer and genital warts.
Approximately 18,000 women and 7,000 men are diagnosed with HPV-associated cancers in the United States each year. One of every 100 sexually active adults in the United States has genital warts and an estimated 20 million people are infected with HPV overall. Men who have sex with men infected with HIV have the highest risk for HPV-related disease.
“Today is another milestone in the nation’s battle against cancer. We hope these deliberations will be a reminder to parents and health care providers about the opportunities we have to protect a generation from the cancers of tomorrow,” said Dr. Schuchat.