The ACIP—the Advisory Committee on Immunization Practices—guides FDA and CDC on how to use a newly licensed vaccine. About
two-and-a-half years before the vaccine's approval, the HPV Working Group began milling through a "huge amount of material"
on the virus and the vaccine, recalls Janet Gilsdorf, MD, a professor of pediatrics and communicable diseases at the University
of Michigan and chair of the working group.
The group ultimately recommended that girls should receive the vaccine between the ages of 11 and 12—and up to age 26, if
they fail to get it at the recommended time. Girls who are 9 or 10 years old can receive Gardasil at their physician's discretion.
In explaining how ACIP chose its target age range, Gilsdorf described one of Gardasil's key challenges—getting adolescent
and pre-adolescent girls to go to the doctor—as a public health opportunity.
"The vaccine is licensed for females 9 to 26," she says. "The ACIP generally constrains its recommendations to what vaccines
are licensed for. We decided to focus on 11 and 12 year olds because there's a strong movement afoot to establish adolescent
visits [to the doctor] at a time of life when people aren't going to the physician for routine care."
Rick Haupt, Merck's executive director of medical affairs
"It was an enormous and appropriate recommendation," Haupt says. "It has huge implications. It sets the standard of medical
care of how vaccines are delivered in this country. It drives physician behavior."
And that's just the United States. Similar discussions played out worldwide. Take the European Union: Even though the European
Agency for the Evaluation of Medicinal Products, a regulatory body, has approved the vaccine, coverage decisions are made
on a country-by-country basis.
The Global Conundrum
The rural communities of India offer a window to the magnitude of cervical cancer in the developing world. There, about one
in three women with cancer will see the disease originate in cervical cells, and the country bears the burden of 20 percent
of all cervical cancer cases worldwide, according to the International Network for Cancer Treatment and Research.
The disease disproportionately affects poor, uneducated Indian women, and often goes undiagnosed until its advanced stages.
The same factors that hinder access to routine gynecologic care also create obstacles for delivering a preventative vaccine.
With Gardasil, Merck faced two audiences: rich countries that can afford to cover the vaccine, but where the threat of disease
is blunted by rigorous screening practices; and poorer nations, where a lack of resources is precisely why cervical cancer
remains a real and present danger. About 80 percent of cervical cancer cases are diagnosed in the developing world.
The Indian Council of Medical Research has partnered with Merck to host clinical studies of Gardasil. Merck also is working
with nonprofit group PATH, on a grant from the Bill & Melinda Gates Foundation, to get lower-priced doses of the vaccine to
girls who wouldn't otherwise receive it. "We've been working very closely with non-governmental organizations...to put together
important information that would allow access in the developing world," Barr says.