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roval of a number of new products recently, including Gardasil, which address significant public health needs.’

Gardasil is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period. Gardasil however does not offer protection against less common HPV types not included in the vaccine, Therefore the importance of pap smear to rule out changes in cervical lining due to cancer still remains.

‘This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA's commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults,’ said Jesse Goodman, MD, MPH, Director of FDA's Center for Biologics Evaluation and Research.

Studies in some 21,000 women have shown how Gardasil has worked in women between the ages of 16 and 26 by giving them either the vaccine or placebo. The results showed that in women who had not already been infected, Gardasil was nearly 100 percent effective in preventing precancerous cervical lesions, genital warts precancerous vaginal and vulvar lesions caused by infection with the HPV types against which the vaccine is directed.

The studies also showed that the vaccine is only effective when given prior to infection. Immune response was found to be as good in 9-15 year olds as in 16-26 year olds.

Evaluation of the safety of the vaccine only revealed mild reactions such as pain or tenderness at the site of injection.

Gardasil is manufactured by Merck & Co., Inc., of Whitehouse Station, NJ. br>

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