Merck's Vaccine Victory Not Yet Complete

Stock quotes in this article: MRK  

The ACIP's vote will influence insurers as well as government agencies that could help people who can't afford $360 for the three-shot Gardasil regimen. Insurers "usually cover" vaccines endorsed by vaccine advisers, says the CDC. "However, while some insurance companies may cover the vaccine, others may not," the agency says.

The ACIP will govern the response of the federal Vaccines for Children program, which provides free vaccines to children and teens under 19 who are uninsured, Medicaid-eligible, American Indian or Alaska natives. If ACIP votes in the affirmative, Gardasil will be included.

The advisory group's vote also could influence the states that provide free or low-cost vaccines to the uninsured at public health clinics. Merck recently said Gardasil would be part of a new program to provide free vaccines to adults who are uninsured or who can't afford the medications.

Money and Medicine

Earlier this month, the FDA approved Gardasil to much medical acclaim for fighting HPV, the most common sexually transmitted disease in the U.S.

"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," Dr. Andrew von Eschenbach, acting FDA commissioner, said on June 8 when the agency cleared Gardasil.

Gardasil is approved for females between the ages of 9 and 26. It covers two types of HPV that account for 70% of cervical cancers and two types of HPV that cause 90% of genital warts. The vaccine doesn't protect women against other types of HPV, and it doesn't help women who are already infected.

Needless to say, a lot is riding on the ACIP vote.

"The ACIP is a distinct, stand-alone entity," says Susanna Matter of Leerink Swann in a June 9 research report. "Therefore, despite the FDA's strong endorsement of Gardasil, its placement on the national immunization schedules is not guaranteed."

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