The Boston Globe on Monday examined pediatrician and parental reactions to issues surrounding the potential FDA approval of Merck's experimental human papillomavirus vaccine Gardasil, including how to "pitch" the vaccine, what parents will tell their children about it and the vaccine's high cost and multidose administration (Goldberg, Boston Globe, 5/29). Merck in October 2005 announced that Gardasil in clinical trials was 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. The trials showed the vaccine -- given in three injections over six months -- also was about 99% effective in preventing HPV strains 6 and 11, which together cause about 90% of genital wart cases. An FDA advisory committee earlier this month in a 13-0 vote said that Gardasil is safe and effective for girls and women ages nine to 26, which effectively recommends that the agency approve the vaccine for sale and marketing to the age group. Although FDA is not required to agree with the advisory panel's recommendations, it often follows them (Kaiser Daily Women's Health Policy Report, 5/19).

Vaccine Administration Issues
According to the Globe, some parents said they might not delve into "awkward questions of sexuality" if they decided to vaccinate their daughters. David Watson, president of Pediatrics West, said most pediatricians are "leery about going into the gory details about different sorts of sexual transmission" when talking to parents about Gardasil. "I'll probably focus on the fact that the vaccine prevents cervical cancer in my sell and not on the fact that this prevents a sexually transmitted [infection]," Joseph Hagan, a Burlington, Vt.-based pediatrician, said. Several physicians said the "logistics" of cost -- which is expected to be about $300 to $500 per vaccine -- and the three visits required to administer Gardasil likely will create "more problems than parental attitudes," the Globe reports. Although insurance companies normally cover FDA-approved vaccines, Gardasil initially might not be covered by health insurance plans, according to the Globe. In addition, the three-visits requirement could be a "huge problem" because "[a]dolescents, unless they're dragged by their parents, don't come in unless they think they're pregnant, they have acne, or they need a note for soccer or work," Victoria McEvoy, medical director and chief of pediatrics at Mass General West Medical Group, said (Boston Globe, 5/29). The Globe on Monday also examined the safety and efficacy of Gardasil and FDA requirements for vaccine development and approval (Weintraub, Boston Globe, 5/29).