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Title: FDA Approves Expanded Uses for HPV Vaccine to Include Prevention of Certain Vulvar, Vaginal Cancers
URL: http://www.pslgroup.com/dg/22C5D2.htm
Doctor's Guide
September 15, 2008

ROCKVILLE, Md -- September 15, 2008 -- The US Food and Drug Administration (FDA) has approved additional indications for the Human Papillomavirus (HPV) vaccine (Gardasil) to include the prevention of vaginal and vulvar cancer caused by HPV types 16 and 18 in girls and women aged 9 to 26 years.

"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," said Jesse L. Goodman, MD, FDA's Center for Biologics Evaluation and Research, Rockville, Maryland.

"While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV."

The new indication approval is based on studies which followed more than 15,000 participants from the original studies for about 2 additional years. Approximately half had received the vaccine as part of the original study, while the other half did not receive the vaccine and served as a control group.

Among females who tested negative for HPV types 16 or 18 at the start of the study, the vaccine was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions.

In the control group that did not receive the vaccine, 10 individuals developed precancerous vulvar lesions and 9 developed precancerous vaginal lesions, all related to HPV types 16 or 18. No one in the vaccine group developed either kind of precancerous lesion due to HPV types 16 or 18.

There was no evidence for benefit among women found to have been previously infected, prior to immunisation, with the HPV types included in the vaccine.

The vaccine's label has been revised to note that presently available information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that the vaccine does not protect against diseases caused by HPV types not contained in the vaccine.

The most commonly reported adverse events have included syncope, pain at the injection site, headache, nausea, and fever.


SOURCE: US Food and Drug Administration

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