FDA approves Cervarix human papilloma vaccine as cervical cancer deterrent

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The Food and Drug Administration today approved Cervarix, the vaccine against human papilloma virus (HPV) manufactured by GlaxoSmithKline, for use in girls and young women ages 10 to 25. An FDA adivsory panel recommended approval of the vaccine on Sept. 9 and the agency followed the group’s recommendation. The vaccine joins Gardasil, which was introduced in 2006. Glaxo had applied for approval about the same time, but consideration of the vaccine was delayed because of concerns -- since discounted -- about potential adverse reactions.

[Updated at 10:32 a.m.: The agency today also approved the use of Gardasil, manufactured by Merck & Co., for boys and men ages 9 to 26 for the prevention of genital warts. The advisory panel had also recommended such approval in September.]

Both vaccines protect against two of the 15 strains of HPV that cause cervical cancer: types 16 and 18. They have been shown to be more than 90% effective in preventing tumors caused by those strains, which account for about 70% of all cervical cancer cases. Gardasil also protects against two other strains of HPV, types 6 and 11, associated with genital warts, which are sometimes precursors of anal and penile cancer.

About 20 million Americans are infected by HPV each year. Most infections are cleared by the body, but the virus is thought to be responsible for an estimated 11,000 cases of cervical cancer each year, with 4,000 deaths. In men, the virus has been linked to anal cancer, which strikes about 2,000 men per year, and penile cancer, which is even rarer.

Gardasil has been controversial. Some religious critics argue that it seems to give young girls a license to engage in sexual intercourse. Other critics believe it has been linked to many adverse events, although the advisory panel discounted such claims. The vaccine is also quite expensive, about $400 for the recommended panel of injections.

-- Thomas H. Maugh II