FDA Reviews GARDASIL Vaccine

Written by OJ Fagbire

Sunday, 24 June 2007

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GARDASIL ®, the new vaccine against Human Papillomavirus (HPV), is under review by the Food and Drug Administration (FDA). GARDASUL ® is a recombinant vaccine that protects against the main types of HPV (types 16 and 18) that lead to vaginal and vulvar cancer as well as genital warts, and certain cervical lesions. Producers of the vaccine, Merck & Co, expect the FDA to review the vaccine data and provide some action by the beginning of next year.

GARDASIL ® is the first vaccine proven to help prevent cervical cancer. The vaccine is approved only for females between the ages of 9 and 26. It is important to note that the vaccine, while very effective, does not provide 100% protection and should not take the place of annual vaginal screening.

The vaccine is not designed for use as a treatment against active vaginal cancer or genital warts. It has also not shown to prevent other strains of the HPV. Recipients of the vaccine should receive three doses over a period of ix months. GARDASIL® is covered by most private insurances and has recently been included in the Vaccines for Children programs that funds vaccines for individuals who cannot afford them on their own.

HPV is a very common virus that the majority of women get before the age of 50. While in most cases HPV goes away without treatment, in some cases the virus can lead to cervical cancer. This form of cancer is the second leading cause of death in women around the world, almost 240,000 deaths yearly. Some types of HPV can cause genital warts that show up as abnormal on Pap screens and require follow-up visits.

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