Merck and Company are the makers of Gardasil, the vaccine that protects girls and women ages 9-26 against the human papillomavirus (commonly called HPV). Merck recently submitted the drug again to the FDA, attempting to use the vaccine for women ages 27-45 who had not yet contracted the cervical cancer causing virus, HPV.
According to Bloomberg.com, the FDA has "issues" and "questions" about the use of the HPV vaccine in the "older" age group and Merck plans to respond to those "issues" (Merck declined to indicate what the FDA's issues were) by next month. The FDA's concerns for the 27-45 age group do not affect the Gardasil approved for use by girls and women ages 9-26. Beverly Lybrand, senior vice president at Merck stated: "We will continue to persue this and other supplemental approvals to extend the use of this vaccine to others. "
In a study sponsored by Merck last year, results indicated that Gardasil prevented 91% of cases of precancers and genital lesions in women ages 24-45. With cervical cancer killing over 250,000 women a year (according to the World Health Organization) Merck should move fast to work out the kinks of the vaccine and eliminate FDA concerns for this age group.
According to Bloomberg.com, the FDA has "issues" and "questions" about the use of the HPV vaccine in the "older" age group and Merck plans to respond to those "issues" (Merck declined to indicate what the FDA's issues were) by next month. The FDA's concerns for the 27-45 age group do not affect the Gardasil approved for use by girls and women ages 9-26. Beverly Lybrand, senior vice president at Merck stated: "We will continue to persue this and other supplemental approvals to extend the use of this vaccine to others. "
In a study sponsored by Merck last year, results indicated that Gardasil prevented 91% of cases of precancers and genital lesions in women ages 24-45. With cervical cancer killing over 250,000 women a year (according to the World Health Organization) Merck should move fast to work out the kinks of the vaccine and eliminate FDA concerns for this age group.
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