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Home HPV Vaccines HPV Vaccines FDA Rules on Cervical Cancer Vaccines

FDA Rules on Cervical Cancer Vaccines

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Agency approves GSK’s jab for use in the U.S.; expands Merck vaccine’s indication to include males

On October 16, 2009, the U.S. Food and Drug Administration announced two major rulings with HPV/cervical cancer vaccines, approving GlaxoSmithKline’s cervical cancer vaccine, Cervarix®, for use in the U.S. with females ages 10-25 and green-lighting use of Merck’s Gardasil® with boys.

The approval of Cervarix® brings another cervical cancer vaccine to the market; Gardasil® was the first cervical cancer vaccine licensed in the U.S., approved in 2006 for use with girls and young women. In clinical studies both vaccines were highly effective in blocking persistent infections and diseases associated with HPV types 16 and 18, the viral types responsible for about 70% of cervical cancers. The Merck vaccine also protects against HPV types 6 and 11, the “low risk” viral types found with about 90% of genital warts.

Less than a week after FDA’s decision, the Advisory Committee on Immunization Practices (ACIP) voted to recommend vaccination with Cervarix for 11 and 12 year old girls, with “catch up” for those ages 13-25 who have not previously received the vaccine.

At the same time, the committee decided to recommend “permissive use” of Gardasil with males 9-26, which means it can be given at the discretion of health care providers. The committee also voted to include Gardasil® for boys in the federal Vaccines for Children program, a significant move that triggers funding and makes the vaccine accessible to poor children.  Vaccines for Children provides free immunizations to those under age 18 who are Medicaid eligible, are uninsured or underinsured, or are Native American or Alaska Native. The program also covers both vaccines for eligible girls. 

In late September the FDA said it would delay it’s decision on Cervarix®, saying it wanted more time to fully review the product. The announcement came only a day after a 14-year old girl in the U.K. died shortly after receiving the vaccine. GSK says the postponement was not connected to the death, a view backed by public health officials in the U.K. who say the girl’s death was due to a malignant chest tumor discovered during the autopsy. The FDA and Centers for Disease Control and Prevention say Cervarix® and Gardasil® both have excellent safety profiles.