Merck's Vaccine Victory Not Yet Complete

Despite securing Food and Drug Administration approval for Gardasil, the first cervical cancer vaccine, Merck (MRK) still needs more endorsements to ensure big sales.

An advisory group to the Centers for Disease Control and Prevention and state legislatures will play major roles in Gardasil's future, demonstrating to investors that there's more to assessing a drug's prospects than FDA clearance.

Gardasil prevents major types of human papillomavirus, or HPV, which causes cervical cancer and genital warts, and the vaccine was greeted upon approval with considerable fanfare because of its potential. Just how far that potential will take it could soon become easier to gauge.

On June 29, Gardasil goes before the Advisory Committee on Immunization Practice which consists primarily of experts in public health, infectious diseases and pediatric care. Although states have the ultimate say in what vaccines are required of school-aged children, the ACIP's opinion carries considerable influence in the public health arena for vaccinating children and adults.

Failure to win ACIP support would likely doom Gardasil. Lukewarm or narrowly defined support could deflate sales of a vaccine that many analysts believe will be an annual $1-billion-plus seller. Some peak sales estimates are upward of $3 billion.

Influential Group

"While the ACIP recommendation is very significant, the ultimate decision as to whether HPV vaccination will be mandated as a condition of school attendance is the responsibility of each state," says Jason Schwartz, a researcher at the University of Pennsylvania Center for Bioethics, in recent comments on the Web site that he edits for the university's Ethics of Vaccines Project.

"Since that appears to be the key point of contention for critics of the vaccine," Schwartz adds, "the federal actions expected in [late June] will likely only mark the start of months of deliberation, lobbying and scrutiny centering on each state's department of health."