The CDC’s Advisory Committee on Immunization Practices has issued draft recommendations backing routine vaccination of boys aged 11 and 12 years with quadrivalent human papillomavirus vaccine (Gardasil, Merck).
Boys and young men age 13 to 21 years who have not previously been vaccinated against HPV are also included in the recommendation, according to Anne Schuchat, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.
The routine recommendation is an affirmation of the previously permissive recommendation the ACIP issued for boys in 2009.
“Since that time, clinical efficacy data on prevention of the precursors of anal cancer have come out that were very striking [that quadrivalent HPV vaccine] is highly effective against that very severe type of cancer for which we don’t have routine screening […] or very effective treatment,” Schuchat said during a press conference.
Although the vaccine was previously available on a permissive basis to boys and men up until the age of 26 years, the new recommendations are “much stronger,” Schuchat added.
In addition to preventing future cases of genital warts and anal cancer, health officials believe that extending routine vaccination to boys and men may also translate into reduced HPV burden for women.
First added to the recommended routine vaccine schedule for girls aged 11 and 12 in 2006, quadrivalent HPV vaccine uptake among this population has been “disappointing,” according to Schuchat. “There is the potential that vaccinating boys will reduce the spread of HPV from males to females and reduce some of the HPV-related burden that women suffer from.”
“Male vaccination is most cost effective when coverage of females is low and unfortunately here in the U.S., coverage of females is currently low,” Schuchat said, explaining that vaccine’s relative newness may have contributed to patients’ hesitancy.
But now, approximately 40 million doses have been administered in the United States as of September 2011, and clinical data show it is safe and effective in both males and females.
The universal recommendation may further improve uptake simply by making it easier for providers to remember who should be vaccinated. “We know parents are confused about when they ought to be vaccinating their daughters and we hope to improve that messaging going forward,” Shuchat said.
The 11 and 12 year age group was chosen for routine vaccine, because immune responses are more robust among this age group than older groups, while providing an opportunity to vaccinate before sexual activity, Shuchat explained.
The average public sector cost per dose of the quadrivalent HPV vaccine, of which three doses are necessary, is $108, with private sector costs averaging $130 per dose. The vaccine is also available to Medicaid eligible children through the Vaccines for Children Program.
Although many insurance companies cover HPV vaccination, individual costs can vary based on insurance plans. However, provisions in the Affordable Care Act aim to mandate that in the future insurance companies cover ACIP recommended vaccines without co-pays.
The original FDA licensing of the vaccine for use in boys and men was to prevent genital warts. Last year, the licensure was expanded to include anal cancer prevention in both males and females.