CAP Statement on FDA Approval of HPV Vaccine

The Food and Drug Administration (FDA) today approved Gardasil, Merck’s new vaccine that protects against human papillomavirus (HPV) and cervical cancer. This is one of the greatest public health victories since the polio vaccination. FDA experts declared the vaccine safe and effective for girls and women ages nine to 26, and a similar vaccine produced by GlaxoSmithKline has been shown to be effective for women up to 55 years old.

Both Merck’s HPV vaccine and the GlaxoSmithKline vaccine have proven 100% effective against the two strains of HPV that account for 70% of the incidents of cervical cancer in the United States. Recent studies suggest that the Merck vaccine is also effective against strains that cause vaginal and vulvar cancers and is 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 (CDC) estimates that some 20 million Americans have been exposed to HPV, although the vast majority of these infections are with strains that cause no significant health consequences. Two strains, however, are responsible for most cases of cervical cancer in the U.S., a disease that each year affects over 10,000 women in the U.S. and kills more than 3,700 of them.

The FDA’s approval is to be commended, but more work remains to be done. The vaccine will also be examined by 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 adolescents 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 all women are able to obtain and afford it.

For more information, see:

Don’t Let Politics Interfere in the Fight against Cervical Cancer

The Hidden Victims of Cervical Cancer

Facts on HPV (PDF)

Preventing HPV, Easy as 1,2,3 Shots? Ensuring Access to the New Anti-Cancer Vaccines

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