New developments: HPV4 for boys, licensing a bivalent vaccine
At its meeting in October 2009, ACIP decided to approve HPV4 for the prevention of anogenital warts in boys and young men ages 9 to 26.14 The potential benefits of using the HPV vaccine in males include reduced incidence of anogenital warts, possible reduction in HPV-related cancers, and reduced transmission of the HPV viruses in the vaccine to women and other men. The ACIP panel did not recommend routine immunization, however, leaving it up to physicians and patients to decide whether the vaccine is worthwhile. The advisory group said it would take up the question of the vaccine’s effectiveness in preventing HPV-related male cancers at future meetings.
At the same meeting, ACIP also voted to recommend Cervarix, the bivalent HPV vaccine from GlaxoSmithKline, for routine use in girls 11 and 12 years of age for the prevention of cancer and precancerous lesions.14 This vaccine contains antigens against HPV types 16 and 18 and does not provide protection against genital warts. Cervarix has been licensed in other countries and, to date, has demonstrated effectiveness comparable to that of the HPV4 against HPV 16- and 18-related outcomes.1,2,6
The availability of 2 HPV vaccines, 1 against both warts and cervical cancer and the other against cervical cancer only, will present some challenging ethical and practical issues for ACIP, as well as for states and physicians.
Unresolved issues
Some critics of the vaccine have pointed out that neither HPV vaccine has yet been proven to prevent cervical cancer. Because the amount of time it takes HPV infection to progress to cervical cancer is, on average, 10 to 20 years, vaccine trials will need to be continued for years to establish this point. However, high-grade cervical lesions and genital warts are outcomes important to patients on their own and are associated with considerable morbidity. It is unknown how continued use of the vaccine will affect the epidemiology of HPV infection and the incidence of HPV types not affected by the vaccine.
Safety monitoring of the vaccine continues. At this time it appears that syncopal episodes occur at increased rates shortly after administration of the HPV4 vaccine, and vaccine providers are encouraged to follow ACIP recommendations of a 15-minute waiting period after the administration of the vaccine.13 Ongoing studies will continue to look at potential rare adverse reactions and determine if the vaccine is truly a cause of venous thromboembolic events.
The approved age range for the use of HPV4 in women for the prevention of cancer, precancerous lesions, and warts may be expanded above 26 years. The benefit among women of this age will be less than for younger women, because of the higher probability of previous exposure to HPV. ACIP will need to decide on whether the vaccine should be routinely or selectively recommended above age 26.