On Thursday, a Food and Drug Administration (FDA) Advisory Committee unanimously declared Gardasil, Merck’s new vaccine against human papillomavirus (HPV), both safe and effective for girls and women ages nine to 26. In essence, this means that the FDA experts are recommending that the FDA approve this drug for sale and marketing to this population.
Merck’s HPV vaccine, as well as a similar vaccine created by GlaxoSmithKline, has proven to be 100% effective against the two strains of HPV that account for 70% of the incidents of cervical cancer in the United States. The Merck vaccine is also 99% effective against the two strains of HPV responsible for 90% of genital warts. HPV is a little known but very common sexually transmitted infection that is the primary cause of cervical cancer in the U.S. The Centers for Disease Control and Prevention (CDC) estimates that some 20 million Americans are currently carriers of HPV, although the vast majority of these infections are with strains that cause no significant problems. Two strains, however, are responsible for most of the cervical cancer in the U.S., affecting over 10,000 women each year and killing more than 3,700 of them.
The approval of the advisory committee is to be commended, but more work remains to be done. The vaccine will now have to be approved by the FDA, which usually follows the recommendations of its advisory committees. After that, the vaccine will also be examined by the CDC’s Advisory Committee on Immunization Practices (ACIP), which issues recommendations and schedules for the administering of vaccines. Given the prohibitive cost of the vaccine, expected to be several hundred dollars for a three shot series, and the logistical difficulties involved in bringing 10 to 12-year-olds in for multiple doctor visits, it is important that ACIP make recommendations that ensure the vaccine will receive public funding and be readily available. It is not enough to approve this vaccine for the public’s use; we must also ensure that those who need it most are able to obtain and afford it.