Merck & Co. has submitted an application to the Untied States Food and Drug Administration (FDA) to consider Gardasil®, the vaccine against the human papillomavirus, in boys 9 to 26 years to prevent genital warts and other lesions. The FDA has two months to make a decision as to whether the new application meets its standards.
The new application includes data from approximately 4,000 males ages 16 to 26, in which Gardasil prevented 90% of cases of penile cancer and genital warts.
The submission is expected to renew questions regarding the cost-effectiveness of Gardasil.
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