June 8, 2006 — The US Food and Drug Administration (FDA) gave the nod today to a new vaccine that experts are calling one of the most important advances in women's health in recent years. The Merck product is the first developed to prevent cervical cancer, precancerous genital lesions, and genital warts from human papillomavirus (HPV). It got the go-ahead in just 6 months as part of the FDA's new priority-review system—a process developed to advance drugs thought to offer significant health benefits.
"Today is an important day for public health and for women's health and for our continued fight against serious life-threatening diseases like cervical cancer," Mr. Alex Azar, deputy secretary with the US Department of Health and Human Services, said in a statement to the press.
The HPV quadrivalent vaccine will be sold under the trade name Gardasil. It contains no live virus and is given in 3 separate intramuscular injections in the upper arm over a 6-month period. A Merck news release says the vaccine will cost about $120 US per dose—for a total of $360 for immunization.
The vaccine is approved for use in females aged 9 to 26 and is designed to prevent HPV types 16 and 18—the cause of approximately 70% of cervical cancers—as well as HPV types 6 and 11, which are linked to roughly 90% of genital warts.
But the FDA emphasized to reporters that the product does not protect women if they have already been infected with HPV before vaccination. Regulators say this fact "indicates the importance of immunization before potential exposure to the virus." The product is also not designed to protect against less common HPV types, and routine Pap screening will therefore remain critical moving forward.
Earlier this week at the 42nd annual meeting of the American Society of Clinical Oncology in Atlanta, Georgia, attendees were enthusiastic about what vaccines like this could mean. Many called this "a new era in cervical cancer."
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