HPV immunization in males becoming a ‘no-brainer’

Issue: December 2010

NEW YORK CITY - More than 100 countries have now licensed one or both of the approved HPV vaccines for females aged 9 to 26 years. According to a speaker here at the 23rd Annual Infectious Diseases in Children Symposium, held in New York City, the HPV vaccine shows good data for cancer prevention not only in females, but in males as well.

Kenneth Alexander, MD, PhD, Professor of Pediatrics and Chief, Section of Pediatric Infectious Diseases of the University of Chicago presented a discussion making the case for HPV immunization in both males and females.

Alexander reminded physicians that as of October 2009, there are two ACIP-recommended vaccines for females aged 9 to 26 years. HPV4 (Gardasil, Merck) has been approved for prevention of cervical, vaginal and vulvar malignancies, dysplasias, and warts due to HPV 6, 11, 16, and 18, as well as HPV2 (Cervarix, GlaxoSmithKline) for the prevention of cervical malignancies and dysplasias due to HPV 16 and 18.

“As time goes on, data for supporting the use of these vaccines are just getting stronger and stronger. The vaccines work, they’re safe, and their benefits appear to be worth the costs,” said Alexander.

Earlier this year, HPV4 was approved for permissive use in males aged 9 to 26 years for prevention of genital warts caused by HPV 6 and 11. However, data now indicates that the HPV4 vaccine can prevent anal cancers and anal intraepithelial neoplasias. In response to these findings, the FDA’s Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for HPV4 immunization as a means for preventing anal cancers and anal intraepithelial neoplasias.

In both genders, HPVs cause genital warts, genital malignancies, anal malignancies, and orpharyngeal and oral cavity cancers, as well as recurrent respiratory papillomatosis. Alexander noted, “Perhaps our biggest motive for HPV immunization is the one (currently) supported by the fewest data. I am pleased that the vaccine is effective against anal cancers. My earnest hope is that the HPV4 vaccine also prevents head and neck cancers.”

Alexander emphasized the importance of head and neck cancers in HPV immunization. Approximately half of cancers in the oral cavity are caused by HPV 16. These cancers are becoming more and more common, and will ultimately be more common than cervical cancers, he noted.

However, research suggests that the cost-benefit for HPV immunization in males is not as favorable as female immunization until it’s proven that HPV immunization prevents not only anal cancers, but head and neck cancers as well.

Unlike cervicovaginal disease and anal disease, head and neck malignancies do not, in 2010, have well established pre-cancerous states, Alexander said. As such, a definitive trial demonstrating vaccine efficacy against head and neck cancers is unlikely any time soon. This leaves immunizers with a difficult choice. “Do we want to wait 30 years and not immunize and risk losing young people to head and neck cancer, or do we make the leap of faith and immunize for what we think is likely to be the case, that the vaccine will prevent head and neck cancers given that it already prevents cervical and anal cancers?”

“We are now, more than ever, in the cancer prevention business, and this vaccine shows good data for cancer prevention not only in girls, but in boys. Increasingly, the use of the vaccine for both genders is becoming a no-brainer,” Alexander told Infectious Diseases in Children. – by Ashley DeNyse

For more information:

Alexander A. Making the case for HPV Immunization. Presented at: the 23rd Annual Infectious Diseases in Children Symposium; Nov. 20-21, 2010; New York City.

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